instructions for use

Transcription

CAT No. 8040883
Operator's Manual
VITRO
' Ortho:Clinical Diagnostics
a ô&wton^flo^HiOH company
Export authorized under general license GTDA (General Technical Data Available)
IMPORTANT
The information contained herein is based on the experience and knowledge relating to the subject
matter gained by Ortho-Clinical Diagnostics, Inc. prior to publication.
No patent license is granted by the information.
Ortho-Clinical Diagnostics, Inc. reserves the right to change this information without notice, and
makes no warranty, express or implied, with respect to the information.. The company shall not be
liable for any loss or damage including consequential or special damages, resulting from the use of this
information, even if loss or damage is caused by its negligence or other fault.
VITROS is a trademark of Ortho-Clinical Diagnostics.
©2004 Ortho-Clinical Diagnostics, Inc. All rights reserved.
2004-03-30
About the VITROS DT II System Binder
This binder contains all you need to know to analyze samples on the
VITROS DT60 II Chemisty System and the accompanying
VITROS DTSC II and VITROS DTE II Modules.
Operator's Manual
This section provides general information about how to operate and
maintain the VITROS DT II System. Topics covered are:
• Operating Instructions
• Coronary Risk Classification (CRC) and Derived Tests
• Calibration
• Instrument Care and Cleaning
• Quality Control
• Options
• Troubleshooting
• Instrument Status Messages
• Coded Warning Messages
• Installation and Site Specifications
• Warranty
In writing the Operator's Manual we strove to achieve multiple goals
in meeting your needs. The Operator's Manual has some sections (1,
6, and 7-12) that are primarily informative. These are formatted
vertically, making it easier to read these sitting down or at a desk.
Sections 2-5 and 1 3 are considered functional, for daily use while
you are operating the analyzer, and are oriented horizontally.
Rev. 2004-03-30
VITROS DT II System Binder
VITROS DT II System
I
VITROS Chemistry Products DT Instructions for Use Manual
|
This separate manual provides information on the specific
chemistries that the DT II System analyzes. It includes the following
information for each chemistry:
• Intended Use
• Summary and Explanation of the Test
• Principles of the Procedure
• Test Type and Conditions
• Warnings and Precautions
• Reagents
• Specimen Requirements
• Testing Procedure
• Calibration
• Quality Control
• Expected Values and Reporting Units
• Limitations of the Procedure
• Performance Characteristics
iv
VITROS DT II System Binder
VITROS DT l| System
Rev. 2004-03-30
Revision History
Revision Date
Description
2004-03-30
About the VITROS DT II System Binder iii-iv, updated to reflect moving
Instructions for Use to separate manual
Revision History v-viii, updated to reflect current documentation
List of Revised Pages ix-x, updated to reflect current documentation
Table of Contents xi-xiv, updated to reflect current documentation
Chapter 1, page 1 - 1 , removed reference to Hb
Chapter 2, page 2-19, 2-23 and 2-25, inserted text for tracking error
Chapter 4, page 4-3, updated "When to Calibrate" section
Chapter 4, page 4-3, removed reference to Hb
Chapter 4, page 4-11, removed section "Preparing DT Hb Calibrators"
Chapter 4, page 4-13 and 4-15, inserted text for tracking error
Chapter 6, page 6-3, removed section "Preparing DT Hb controls"
Chapter 8, page 8-3, added "Unexpected Results" to section title, added bullet
for calibration failures
Chapter 8, page 8-4, In 'Possible Causes" extracted text from third bullet to
emphasize importance, added bullet for overfilled slide disposal box
Chapter 8, page 8-4, In "if You Suspect a Tracking Error" added text to review
and confirm previous results
Chapter 8, page 8-4, In "Important Points to Remember" underlined text for
emphasis
Chapter 9, page 9-8, added Important note to prevent tracking error
Chapter 1 0, page 10-1 and 10-3, added tracking error text
Chapter 1 0, page 10-2 and 10-20, removed reference to Hb
Chapter 10, page 10-10, added tracking error text
Rev. 2004-03-30
Operator's Manual
VITROS DT II System
Revision Date
Description
2003-10-01
Note: Formatting has changed but only pages with content changes are labeled
2003-10-01.
Added "For in vitro Diagnostic Use"
Replaced "Methodology Sheets" with "Instructions for Use"
About, pages iii-iv, edited to reflect current documentation
Revision History, v-vii, added update information
List of Revised Pages, viii, updated to include all pages
Table of Contents, xi-xii, updated
Introduction, page 1-1
Introduction, pages 1-7-1-8
Introduction, pages 1 -7 and 1 -9; removed DT from VITROS Micro Tips
Section 2.2.1, page 2-5
Section 2.2.1, page 2-7, updated the power socket illustration
Section 2.2.1, page 2-27, changed J&JCD to OCD
Se tion 6.10, page 6-13
Section 7.2, page 7-3, changed J&JCD to OCD
Section 7.2, page 7-7, changed J&JCD to OCD
Section 8.2, page 8-3-8-6, replaced information with a reference; changed
paging to 8-3-8-4
Section 9.1, page 9-5
Section 10.1.8, page 10-19
Revised Instructions for Use:
• ALB DT
• ALT DT
• AST DT
• BUN DT
• CHE DT
• CKDT
• Cl- DT
• CREA DT
• FeDT
• LAC DT
• LDH DT
• Mg DT
• Na + DT
• NBIL DT
• N H , DT
• THEO DT
• TBIL DT
• TPDT
• UrCr DT
VI
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
Revision Date
Description
2003-08-11
Revised Instructions for Use for:
• AMYL DT
• CO 2 DT
• GGT DT
• GLU DT
• HDLC DT (Using the VITROS DT HDL Cholesterol Kit)
• HDLC DT (Using the VITROS DT Micro HDL Cholesterol Kit)
• Li DT
• URIC DT
Removed:
• Anion Gap Calculation Supplement, C-363
• Coronary Risk Classification Supplement, C-359
• Globulin and Albumin_Globulin Calculations Supplement, C-360
• VLDL, LDL, and CHOLJHDLC Ratio Calculations Supplement, C-362
2003-04-30
New Format.
New organization and sections consistent with IVD Directive.
Revised Instructions for Use:
• ALKP DT
• Ca DT
• CHOL DT
• CKMB DT
• CRSC DT
• K+ DT
• LI PA DT
• PHOS DT
• TRIG DT
2OO3FEB
Update the Methodology Section to include revision to Test Methodology:
CK2003FEB01
10/01
Revised Table of Contents to include Test Methodology Sheets.
Revised Section 5, pages 1-46, deleted all references to cleaning and charging
the VITROS DT Pipette. Refer to the VITROS DT Pipette User's Guide for
information on cleaning and charging the DT Pipette.
• Section 5, pages 1-10, minor text and format changes.
• Section 5.1, page 3, deleted reference to the daily cleaning of the DT Pipette.
• Section 5.3, pages 19-26, removed.
• Section 5.4, pages 27-34, removed.
• Updated Methodology Section to include Test Methodologies: NBIL
2001 SEP24, TBIL 2001 SEP24.
11/00
Updated Methodology Section to include Test Methodologies: GGT 8/99, CK
2000SEP21, CREA 2000SEP21.
1/99
Reflects company name change to Ortho-Clinical
Johnson Company.
4/96
Reprinted for the introduction of J&JCD VITROS Chemistry Systems trademark
nomenclature.
Rev. 2004-03-30
Operator's Manual
VITROS DT II System
Diagnostics, a Johnson &
VII
Revision Date
Description
5/95
Reprint of all pages.
Trade dress changes.
Style changes for consistency.
Section 2.2.1, pages 7-1 7, changes made to reflect new pipette information.
Section 2.2.2, page 23, item 6, new information added.
Section 4.2, minor text changes.
Section 4.4, page 13, pipette graphic updated.
Section 4.4, page 15, step 4, minor text changes.
Section 5.3, pages 19-25, new information on cleaning the DT Pipette.
Section 5.4, pages 27-33, heading changed to Charging the DT Pipette and
new information added.
Section 5.5, page 35, clean cloth changed to cotton swab.
Section 8.2, page 3, new pipette troubleshooting information added.
Section 8.3, Analyzer Tracking Errors section added.
Section 11.1, page 2, item 3, reference to Electrical Requirements added.
Section 11.2.3, page 5, rewrite.
Section 11.3, page 6, changes in headings and rewrite of item 2 under 11.3.1
and 11.3.2.
9/93
Reprint of all pages.
2/92
Table of Contents undated to reflect derived tests in Section 3 and switch of
subheads in Section 11.
Section 2, page 13, second bullet under Ektachem DTE pipette removed.
Section 3, style changes to comply with other subheads.
Section 3, pages 11 and 13, md/dl changed to mg/dl.
Section 3, pages 18-36, new pages added as per derived test development.
Section 4.3.2, page 11, second bullet changed.
Section 4, page 1 7, IMPORTANT NOTE changed.
Section 6.4.2, page 3, second bullet changed.
Section 7, pages 4-10, new pages added as per derived test development.
Section 11.3.1 and 11.3.2, heading corrections.
1/92
Updated Sections 3 & 7 to include new features.
Revised tab for Section 3 to include both CRC and Derived Tests.
Revised Section 3 in Table of Contents to reflect additions.
9/91
First release.
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
List of Revised Pages
Each page in your manual should be at the date listed below:
Chapter or Section
Page Number(s)/Portrait (P)
or Landscape (L)
Revision Date
P
Rev. 2004-03-30
Title Page/Copyright
Rev. 2004-03-30
About
Revision History
Table of Contents (book)
iii-iv
v-viii
ix-x
xi-xiv
P
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P
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Introduction
1-1
1-2-1-6
1-7-1-9
1-10
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Operating Instructions
2-1-2-4
2-5
2-6
2-7
2-8-2-18
2-19
2-20-2-22
2-23
2-24
2-25
2-26
2-27
2-28-2-34
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CRC
3-1-3-36
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Calibration
4-1-4-2
4-3
4-4-4-10
4-11
4-12
4-13
4-14
4-15
4-16-4-22
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Instrument Care & Cleaning
5-1-5-30
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Rev. 10/01
Quality Control
6-1-6-2
6-3
6-4-6-12
6-13
6-14
P
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Options
7-1-7-2
7-3
7-4-7-6
1-7
7-8-7-10
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Rev. 2003-10-01
Troubleshooting
8-1-8-2
8-3-8-4
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Operator's Manual
VITROS DT II System
IX
Chapter or Section
Page Number(s)/Portrait (P)
or Landscape (L)
Revision Date
Status Messages
9-1-9-4
9-5
9-6-9-7
9-8
P
P
P
P
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Rev. 2004-03-30
Coded Warning Messages
10-1-10-3
10-4-10-9
10-10
10-11-10-18
10-19
10-20
10-21-10-22
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Installation and Site Spec
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Warranty
12-1-12-2
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Log Sheets
13-1-13-3
13-4-13-8
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5/95. Reprinted 1/99.
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
Table of Contents
About the VITROS DT II System Binder
Operator's Manual
VITROS Chemistry Products DT Instructions
for Use Manual
Revision History
Table of Contents
Section 1
Getting To Know Your
VITROS DT II System
1.1
1.2
1.3
1.4
1.5
1.6
Section 2
2.1
2.2
2.3
Rev. 2004-03-30
General Description
Equipment Features
1.2.1 Keyboard and Functions
1.2.2 Display Panel
1.2.3 Printer and Results Printout
Principles of Operation:
VITROS DT60 II Chemistry System
1.3.1 Slide Identification
1.3.2 Slide Spotting
1.3.3 Incubation and Readout
Principles of Operation: VITROS DTE II Module
Principles of Operation VITROS DTSC II Module
Supplies and Supply Handling and Storage
1.6.1 Storage Temperature Requirements
1.6.2 VITROS DT Slides
1.6.3 VITROS DT and DTE Pipettes and Micro Tips
1.6.4 VITROS DT Calibrator Kits
1.6.5 ViTROS DT Control I and DT Control II
1.6.6 VITROS DT Reference Fluid
1.6.7 VITROS DTE Dual-Sample Cups..
1.6.8 Printer Paper
1.6.9 VITROS DT Accessory Kit*
Start-up Procedure
Testing Procedure
2.2.1 Pipetting Techniques
2.2.2 Steps for Analysis on the VITROS DT II System ....
Calibration Data Module and
Chemistry Language Module
2.3.1 Description of Calibration Data Module
Operator's Manual
VITROS DT II System
iii
iii
iv
v
ix
xi
1-1
1-2
1-2
1-3
1-3
1-3
1-3
1-3
1-4
1-5
1-5
1-5
1-5
1-6
1-6
1-6
1-6
1-7
1-7
1-7
1-7
1-7
1-8
1-8
1-8
1-8
1-9
2-1
2-5
2-5
2-19
2-27
2-27
xi
2.3.2
2.3.3
2.4
2.5
Description of Calibration Language Module
2-27
How to Install a New Calibration Data Module
(CDM) and a Chemistry Language Module (CLM) .2-29
Normal Shutdown Procedure
2-33
Emergency Shutdown
2-33
Section 3
Coronary Risk
Classification (CRC)
3.1 CRC Overview
3.2 Entering Data for Coronary Risk Classification
3.3 Printing CRC Results
Derived Tests
3.4 Overview
3.5 GLOB and A/G
3.6 Lipid Calculation (VLDL, LDL and CHOL/HDLC Ratio)
3.7 Anion Gap (AGP)
3-1
3-3
3-13
3-21
3-21
3-23
3-27
3-33
Section 4
Calibration
4.1
4.2
4.3
4-1
4-3
4-5
4-7
4-11
4-13
4.4
Section 5
Instrument Care and
Cleaning
5.1
5.2
5.3
5.4
Section 6
Quality Control
6.1
6.2
6.3
6.4
6.5
6.6
6.7
6.8
XII
Why You Need to Calibrate
When to Calibrate
How to Calibrate
4.3.1 Preparing VITROS DT Calibrators
4.3.2 Entering the Calibration Mode
Calibration
Daily Cleaning
Weekly Cleaning
Other Cleaning: VITROS DT60 II Chemistry System
FORSHead
'...
..
Paper Loading
,;;:
5.4.1 Removing the Paper
5.4.2 Inserting Paper
'.
What Is Quality Control?
What Are Controls?
How Often Should Controls Be Run?
How to perform a quality control test
6.4.1 Preparing Lyophilized Controls
Analyzing the Controls
How to Record the Results
6.6.1 Recording Quality Control Results on a Log
6.6.2 Recording Quality Control Results on a Graph
Interpreting Control Results
6.7.1 Interpreting the Control Results from the Log
6.7.2 Interpreting the Control Results from the Graph
Establishing Your Own Control Ranges
6.8.1 How to Calculate the Mean
6.8.2 Variables to Consider in Establishing the Mean
Operator's Manual
VITROS DT II System
5-3
5-5
5-19
5-21
5-21
5-23
6-1
6-1
6-1
6-2
6-2
6-3
6-4
6-4
6-5
6-6
6-6
6-6
6-7
6-8
6-9
Rev. 2004-03-30
6.8.3 Calculating the Standard Deviation
6.8.4 How to Calculate a Standard Deviation
6.9 Quality Control Troubleshooting Chart
6.10 Factors to Consider When Your Results Are Out of Range
Section 7
Options
7.3
7.4
How to Run Options
Options for the VITROS DT60 II Chemistry System
7.2.1 Serial Communication Options for the
DT60 II System
Options for the VITROS DTE II Module
Options for the VITROS DTSC II Module
Section 8
Troubleshooting
8.1
8.2
8.3
General Troubleshooting
Pipette Troubleshooting
Unexpected Results (Analyzer Tracking Errors)
8-1
8-3
8-3
Section 9
Instrument Status Messages
9.1
Status Messages
9-1
Section 10
10.1 Coded Warning Messages
10.1.1 Calibration (C)
10.1.2 Data Storage (D)
10.1.3 Electrometer (E)
10.1.4 Instrument Function (F)
10.1.5 Temperature (H)
10.1.6 Communications (N)
10.1.7 Reflectometer (R) DT60 II System
10.1.8 Reflectometer (L) DTSC II Module
Section 11
Installation and Site
Specifications
11.1 Installation
11.2 Site Specifications
11.2.1 Space Requirements
11.2.2 Environmental Requirements
(Temperature, Humidity, and Altitude)
11.2.3 Electrical Requirements
11.2.4 Refrigerator and Freezer Space
11.3 Moving the Analyzer
11.3.1 Relocation Outside the Office
11.3.2 Relocation Within the Office
11-1
11-3
11-3
12.1 New Equipment Warranty VITROS DT II System
12.2 New Accessory Warranty VITROS DT Pipette and
VITROS DTE Pipette
12-1
Section 12
Warranty
Rev. 2004-03-30
7.1
7.2
6-9
6-10
6-12
6-13
Operator's Manual
VITROS DT II System
7-1
7-1
7-8
7-9
7-10
10-1
10-1
10-4
10-6
10-10
10-14
10-16
10-18
10-19
11-4
11-5
11-6
11-6
11-6
11-6
12-2
XIII
Section 13
Log Sheets
CALIBRATION LOG
13-1
SERVICE LOG
13-2
TEST/REAGENT LOG
13-3
VITROS DT II System Maintenance Log
13-4
VITROS DT II System Quality Control Log
13-5
Levey-Jennings Quality Control Chart for VITROS DT II System.13-6
Section 14
Instructions For Use
xiv
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
Getting To Know Your VITROS DT II System
This manual is designed to familiarize you with the operation of your
VITROS DT60 II Chemistry System and, if applicable, your ViTROS
DTE II and VITROS DTSC II Modules. We suggest that the operator
become familiar with the information in this manual prior to
operating the analyzer and the associated modules.
1.1 General Description
Intended Use
For in vitro diagnostic use.
The VITROS DT60 II System uses VITROS DT Slides to perform a
number of discrete clinical tests on serum or plasma specimens. All
reactions needed for a single quantitative measurement take place
within the multilayered analytical element of the slide. A slide is
used once for a single patient test and is then discarded. The unique
properties of these slides eliminate the need to store, mix, and
dispose of liquid reagent chemicals and permit reliable analyses with
a very small patient sample.
All processes performed by the analyzer are controlled by a selfcontained microcomputer. You communicate with the
microcomputer through the keyboard; it communicates with you
through messages that appear on the display screen and printouts.
TABLE 1 Summary of System Characteristics
.and
y
^mîM^MstC:
h. ::! I l l : :Jhr:
: the specific Instructions;for Use^ta;rrrore: infofrrfaiti(Jinr;
'Specimen Sample: - : : : m : "•" :v •;: )•:'!':: •••""% N#i::::;:;; : :.n •; C i i H J
Serum or|p)asma*
; : ';S.f-wi:;H-|Vi; i -^XM^/
Sample Size:
:;
• -^r^
; 1 ; Q ( J L p e r t e s t r T " ; ^ : : ; : ; / : :: » : :
:
•: y '• -^ ^'•un^&S^,
•L
- v i i J •••••••
JJiinii..
;
:1 ^'^
M
;
per -lest JResutfc
VITR(3iS:PT60 II Chemistry
VlTRQfilpE II Module: A
dJfc
iModule:
^ f K W | > M g h p u t Rate:" • •" '^îW^Bttlu;
I ^"••'•1
DTOpli : l-i|eni^try:Systern: i;: ApproximiSlf.feS tests per hour
0 I E i r M o | ( u ] e : i'Approxiniately 15 testsêrihour -M
:
y' : : ' ^ ^ M l ^ = ^^fflGscJWlijt^tiK" -t 5 f^M-1^!^1^ -hour••:|-:i:':.:. :
. •
* Appropriate anticoagulants for plasma specimens are suggested in the test
Instructions for Use
Rev. 2004-03-30
Operator's Manual
VITROS DT II System
1-1
1.2 Equipment Features
1.2.1 Keyboard and Functions
The keyboard is used to issue commands to the analyzer's
microcomputer and to enter necessary data. Instructions for using the
keyboard are provided in this section.
To protect the analyzer against damage from spills and to make the
equipment easier to clean, the keyboard consists of a pressuresensitive pad rather than actual keys. An audible tone sounds shortly
after a key is pressed. If no tone sounds, you have to apply more
pressure to the center of the key. A double tone sounds if you attempt
to enter information that is incorrect.
1
print
patient ID
in progress
complete
service mode
cal mode
delete test
chemistry
select
' clear
.shift
enter
SHIFT:
NUMERIC KEYS:
Used to perform all functions shown in red on
your keyboard—test in progress, service
mode, and delete test. Use the shift key first,
then proceed with your second key selection.
Used in entering numeric data, such as patient
identification numbers, and in identifying
calibrators used in the calibration procedure.
ENTER:
Enters the information input via the keyboard into
the microcomputer.
CLEAR:
Erases data from the display panel.
TEST IN PROGRESS/COMPLETE:
Test in Progress: (Press SHIFT key.) Used to
display tests that are currently in the incubator
of the DT60 II System and any active tests in
the DTE II or DTSC II Module.
Test Complete: Used to display the results of
the last 20 tests that were completed.
PATIENT ID:
Used to assign the patient identification
number to a sample. Test results are then
printed with the appropriate patient
DELETE TEST/CHEMISTRY SELECT:
—
Delete Test: (Press SHIFT key.) Used to delete a test
after a slide has been entered, identified and
spotted. When a test is deleted, the slide must
continue through the analyzer, DTE II Module, or
DTSC II Module. The printout indicates that the test
was deleted. Do not remove a slide manually once
deleted.
Chemistry Select: Used to identify a test if the
analyzer is unable to read the information
contained in the barcode. Press the CHEMISTRY
SERVICE MODE/CAL MODE:
Service Mode: (Press SHIFT key.) Used to enter and
exit the service mode and to access various
equipment options.
Cal Mode: Used to enter and exit the calibration
mode. Signals to the microcomputer that the
analyzer is about to be calibrated and registers the
PRINT:
Advances paper in the printer when pressed during
normal analyzer operation.
1-2
Operator's Manual
VITROS DT II System
1.2.2 Display Panel
The liquid crystal display panel is located above the keyboard and
displays messages of up to two 40-character lines. In general, the first
line of the display message tells you the status of the function you are
in the process of performing, and the second line provides
instructions on what to do next.
1.2.3 Printer and Results Printout
The printer is located to the left of the keyboard and is used to print
out test results and other information. It provides a paper record.
1.3 Principles of Operation: VITROS DT60 II Chemistry System
Place the VITROS DT Slide into the loading station of the analyzer.
After loading a slide for the DT60 II System into the loading station,
push the slide advance lever steadily and smoothly to move the slide
into the spotting station.
As the slide enters the spotting station, a bar code reader reads the
laser bar code on the slide to identify the test and the slide
generation number for the microcomputer. The test identification
then appears on the display panel.
When the display says SPOT SLIDE WITH FLUID, insert the
VITROS DT Pipette into the pipette locator and press down on the
pipette button to dispense 10 uL of sample fluid onto the slide in the
spotting station.
An optical drop detector starts the analyzer's built-in timer and
verifies that the slide has been spotted. Then, the analyzer
automatically transports the slide into the incubator.
Operator's Manual
VITROS DT II System
1-3
The incubator can hold a maximum of six slides stacked one on top
of the other. Each slide enters the incubator at the top of the stack
and exits from the bottom. The slides are incubated for
approximately 5 minutes at 37°C (98.6°F).
At the completion of the incubation period, the lower rack assembly
automatically moves the slide from the bottom of the slide stack in
the incubator to the read station. White and black reference readings
are automatically taken. These readings, together with the slide
reading, are used to determine the density of the color formed by the
chemical reactions in the slide. As the lower rack assembly is
retracted, the slide falls on top of the fiber-optics reflection system
(FORS) head in the read station. The FORS head contains red, green,
and yellow light-emitting diodes (LEDs). The appropriate LED is
energized depending upon the type of slide present in the read
station.
The light is transmitted to the slide by fiber optics, and the light
reflected off the slide is conducted to a photodetector within the
FORS head. The microcomputer uses this reflectance reading,
together with the white and black reference readings, a calibration
model, and the stored calibration parameters, to calculate the
concentration of the sample.
This concentration is printed out by the analyzer's printer. The slide
remains in the read station until the next slide pushes it into the slide
disposal box at the rear of the analyzer.
1-4
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VITROS DT II System
1.4 Principles of Operation: VITROS DTE II Module
Place the DT Slide in the loading station on the moduleand use the
slide advance lever to move the slide to the spotting station. As the
slide enters the spotting station, a bar code reader in the module
identifies the test and the slide generation number by reading the bar
code on the slide. The test identification then appears on the
analyzer's display panel.
The VITROS DTE Pipette, a dual pipette designed for use with the
DTE II Module, allows you to simultaneously aspirate sample fluid
and electrolyte reference fluid from the VITROS DTE Dual-Sample
Cup. After the fluid is aspirated, you position the pipette over the
slide in the spotting station. When you press down on the pipette
button to dispense the fluids on the slide, a 3-minute timer is
activated. When the slide is spotted, the indicator on the module
lights up and begins flashing to alert you to wait before loading
another slide.
The electrometer assembly moves over the slide. The slide is then
incubated in place for 3 minutes at 25°C (77°F). The electrometer
has two contact points: one penetrates the contact area on the half of
the slide where the reference fluid was dispensed, the other
penetrates the contact area on the half where the sample fluid was
dispensed.
At the completion of the 3-minute incubation period, a tone sounds
and the electrometer measures the potential difference between the
two ion-selective electrodes in the slide. This potential difference is
related to the difference in ionic concentration between the
reference fluid and the sample fluid. This reading is used by the
analyzer's microcomputer, together with the calibration parameters,
to calculate the concentration of the electrolyte in the sample.
The slide remains in this position until the next slide pushes it into
the slide disposal box in the left side of the module.
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1-5
1.5 Principles of Operation VITROS DTSC II Module
Place the DT Slide for the DTSC II into the pick-up station of the
DTSC II Module. After the slide enters the slide pickup station, it is
automatically moved to the bar code reader in the module. The bar
code scanner identifies the test and the slide generation number on
the slide. This information is then transmitted to the DT60 II System,
where the test identification is displayed on its display panel.
The DT Pipette is designed for use with the DTSC II Module. A green
indicator light on the DTSC II Module, and a message on the DT60 II
System, signal you that you may spot the slide. You then insert the
pipette into the pipette locator and press down on the pipette button
to dispense 10 uL of sample fluid onto the slide in the spotting
station.
The spotting of the slide is automatically detected by an optical drop
detector and the slide is transported to the preheat station.
The slide is transported to the preheat station and then to the
incubator where it is incubated in place at approximately 37°C
(98.6°F) for a time specified by the tes-t. After incubation, while the
slide is being transported to the read station, it momentarily stops to
allow the system to take a white reference reading, a dark reference
reading, and a voltage reference reading, and then transmits these
readings to the DT60 II System for later use.
At the completion of the reference readings, the slide is transported
to the reflectometer read station where it is illuminated with light
from a xenon flash lamp. At this point several readings are taken
depending on the test. The light reflected from the analysis slide
passes through an interference filter of the proper wavelength and
onto a silicon photodetector. The electrical signals from the
photodetector are fed to an analog-to-digital converter and the
resulting data is sent to the DT60 II System. The microcomputer uses
the reflectance readings, reference readings, and the calibration
parameters to determine the concentration of the sample.
When the slide readings are completed, the slide is automatically
moved to the disposal station and into the slide disposal box.
1-6
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1.6 Supplies and Supply Handling and Storage
1.6.1 Storage Temperature Requirements
VITROS slide and fluid boxes are color coded in order to indicate the
storage temperature of the slides and fluids.
• Light blue indicates the product must be frozen at temperatures
less than -18°CorO°F.
• Purple indicates storage in refrigerator or freezer (<8°C or 46°F).
• Yellow indicates storage in a refrigerator at temperatures between
2° an.d 8°C or 36° and 46°F.
1.6.2 VITROS DT Slides
The DT60 II System, DTE II Module, and DTSC II Module each use a
different type of DT Slide for analysis. The slides are individually
wrapped for their protection during storage. The slide wrapper
identifies the test and the slide lot number. The laser bar code on the
slide is used by the analyzer and the associated modules to identify
the slide and the generation number.
1.6.3 VITROS DT and DTE Pipettes and Micro Tips
The DT Pipette (a battery operated pipette) is supplied for use with
your DT60 II System and DTSC II Module. The DTE Pipette is
supplied with the DTE II Module. It is a dual sample pipette designed
to permit you to simultaneously aspirate and dispense sample fluid
and VITROS DT Reference Fluid.
Disposable VITROS Micro Tips are used with these pipettes. These
micro tips are designed to meet the specific metering requirements of
the VITROS DT II System. A tip is used once to spot a single slide and
is then discarded.
1.6.4 VITROS DT Calibrator Kits
Calibration of the analyzer requires the use of calibrator fluids which
are provided in sets.
Storage and stability requirements of calibrators are provided in the
instruction sheet packaged with the fluids. The instruction sheet
should be read prior to using the calibrators. Refer to the specific test
Instructions for Use for special calibration precautions.
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1-7
1.6.5 VITROS DT Control I and DT Control II
VITROS DT Control I and DT Control II contain known amounts of
the same analytes that the analyzer measures in actual patient
samples. Use these to compare analyzer results with known values
which are provided with the control fluid. Quality control verifies the
success of a calibration and allows you to monitor the long-term
performance of the equipment.
Refer to the specific test Instructions for Use for information on DT
Controls I and II.
Storage and stability requirements of unreconstituted and
reconstituted fluids are provided in the instruction sheet packaged
with the fluids and should be read prior to using controls. For
specific analyte stability information, handling precautions and assay
control values, refer to the assay sheet.
1.6.6 VITROS DT Reference Fluid
DT Reference Fluid is required for use with slides that are tested on
the DTE II Module. Reference fluid is supplied in 10 mL squeeze
bottles with a dropper-like tip that permits dispensing fluid into the
DTE Dual-Sample Cup. The fluid is colored to permit you to easily
view the amount aspirated.
The bottle label identifies the fluid generation number, the lot
number, and the expiration date. Storage and stability requirements
are provided in the instruction sheet packaged with fluids and should
be read prior to using reference fluids.
1.6.7 VITROS DTE Dual-Sample Cups
Single-use, disposable dual-sample cups are used in the sample
holder of the DTE II Module. The sample cups contain two wells. As
indicated on the sample carrier in the module, the sample to be
analyzed is placed in the large well, and DT Reference Fluid is
placed in the small well. The wells are positioned in the cup so that
the DTE Pipette will aspirate both fluids simultaneously.
1.6.8 Printer Paper
Thermal printer paper is used in the analyzer's data printer. The
paper is supplied in rolls 57 mm (2.25-inches) wide and 44mm
(1.75-inches) in diameter.
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Rev. 2003-10-01
1.6.9 VITROS DT Accessory Kit51
The VITROS DT Accessory Kit is supplied with each new system.
The kit contains:
• One 3 mL pipette
• One package of 75 pipette tips for the 3 mL pipette
• One package of 100 2 mL plastic sample cups
• One package of 100 plastic sample cup caps
• One package of 100 transfer pipettes
• One box microwipes
• One package of 250 ViTROS Micro Tips
• One package of 1 60 VITROS DTE Dual-Sample Cups
• One VITROS DT Pipette battery recharger
• U.S. customers only
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The previous section gave you an overview of your equipment's operating features. By following the
operating instructions and illustrations in this section, you will discover how easy it is to make your
VITROS DT60 II Chemistry System work for you. As you become more familiar with your DT60 II System,
many of the frequently performed operating procedures explained in this section will become second
nature.
2.1 Start-up Procedure
STEP
1. Prepare materials for use.
ACTION TO TAKE
Allow the controls, slides, and reference fluids to
come to room temperature (15-30 minutes). Unless
otherwise noted on the control sheet packed with
the control, reconstitute a new vial after 7 days.
Write the date on the control and reference fluid
when first opened.
Allow patient samples to come to room
temperature if refrigerated or frozen.
Mix all fluids before using (gently invert several
times).
2. Check power cord connections.
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Check that all power cords are securely plugged
into the proper outlets.
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2.1 Start-up Procedure (continued)
STEP
3. Turn DT60 II System on.
ACTION TO TAKE
The On/Off switch is on the back of the analyzer.
Requires a 20-minute warm-up period.
4. Turn DTSC II Module on.
The On/Off switch is on the back of the module.
Requires a 5-minute warm-up period.
Turning the DTSC II Module off and on every 24
hours will allow it to adjust for changes in lamp
output.
5. Do daily maintenance.
Empty all slide disposal boxes.
Check the end of the.pipettes for residue and clean
if necessary. See the Cleaning the DT Pipettes
section of this Operator's Manual
Press SHIFT and SERVICE keys.
6. Enter date.
Key in option 1 7 and ENTER.
Key in month, day, and year (NN-NN-NN) and
ENTER. Press SHIFT and SERVICE to exit.
7. Run control materials.
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VITROS DT II System
Run the controls on those tests that you will be
using that day. See the How to Perform a Quality
Control Test section of this manual.
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2.2 Testing Procedure
2.2.1 Pipetting Techniques
Samples to be analyzed require accurate fluid dispensing through pipetting. The importance of accurate
pipetting procedures cannot be over-emphasized. Before attempting to analyze patient samples or
performing routine calibration procedures, you should become thoroughly familiar with the pipetting
procedures recommended for the DT Pipette and the DTE Pipette. Follow the simple instructions outlined
on the next page.
Collect and handle the patient sample according to standard laboratory procedures, centrifuging it to
separate the serum or plasma. Place a cap on the container to avoid sample evaporation and
contamination. Refer to Instructions for Use for proper storage of samples if analysis cannot be performed
the same day that the sample is drawn.
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2.2.1 Pipetting Techniques (continued)
COMMENT OR ACTION TO TAKE
DT Pipette
STEPS
DTE Pipette
1. Place disposable tips in the holder.
2. Check pipette(s).
2a. If the message I* R5P] appears in the
display proceed to step 3.
IMPORTANT: When the message appears in
the display the DT P pette may be used to
aspirate samples as long as the display
indicates the presence of at least one
aspiration |* Lo (]. The DT Pipette should
remain plugged into the charger until it is
fully charged.
2b. Plug the recharge unit into a wall outlet.
NOTE: The DT Pipette only charges when the
Long Term Storage switch is in the On
position.
2c. Plug the power cord of the recharge unit
into the power socket on the top of the DT
Pipette.
Power
Socket
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STEPS
DT Pipette
DTE Pipette
2d. Make sure the message \jh
. [ appears
in the display. If it does not, check the
power cord and make sure it is attached
2e. The message Lo will appear in the display
when the DT Pipette is ready to aspirate a
10 uL drop of fluid.
3. Insert tip(s).
Attach a disposable tip by pressing the tip
cone of the DT Pipette into one of the tips
in the tip holder. The tip will click into
place when it is seated correctly.
To attach disposable tips, press the DTE
Pipette firmly into two of the tips in the
holder. The tips will click into place when
seated correctly.
Visually inspect tips to make sure that the
tips project equally from the pipette.
••••?
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STEPS
DT Pipette
DTE Pipette
Swing the sample holder into the loading
position. Place a dual-sample cup into the
holder so that the small well fits into the
small depression in the holder and the large
well fits into the large depression in the
holder.
4. Insert and fill dual-sample cup.
• Gently invert the bottle of VITROS DT
Reference Fluid to mix the fluid, and then
squeeze at least 4 drops into the small well
of the cup. Using a transfer pipette, pipette
4 drops (need at least 50 uL) of sample to be
analyzed into the large well of the cup.
IMPORTANT: Avoid bubbles in the fluid.
• Gently swing the sample holder back into
place.
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STEPS
5. Aspirate fluids.
DT Pipette
DTE Pipette
• Hold pipette in vertical position.
Hold pipette in vertical position.
• Insert the tip below the surface of the fluid,
but not to the bottom of the fluid container.
Depress button and continue to hold button
down as you insert pipette into pipette
locator at the aspiration station.
• Press the Start button to aspirate 10 uL of
fluid.
NOTE: The start button must be pressed twice
to aspirate a sampje just before the messages
f Ltffl] and f LoG] appear. This is an
indication that the pipette needs to be
charged.
• Remove the DT Pipette from the fluid
within two seconds.
Slowly release pipette button and wait one
second before removing pipette from the
pipette locator in the aspiration station.
Hold the pipette vertically whenever there
is fluid in the.tips. If you tilt the pipette or
lay it on its side, fluid might enter the
mechanism, causing it to become clogged.
If this occurs, clean the pipette immediately.
IMPORTANT: A dotted line will appear in the
display for two seconds while the DT Pipette
is waiting. The pipette must be removed from
the fluid before the dotted line disappears to
prevent accidental aspiration of additional
fluid.
After the two second pause, the DT Pipette
will aspirate 2 uL of air. Upon completion
of the 2 uL pullback, the message j< d5P|
will appear in the display.
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STEPS
6. Remove excess fluid.
DT Pipette
DTE Pipette
Remove any droplets which may be
clinging to the outside of the tip by taking a
laboratory tissue and wiping the outside of
the tip in a light, quick, downward motion.
Do not wipe across the bottom of the tip.
To remove any droplets which may be
clinging to the outside of the tips, take a
laboratory tissue and wipe the outside of
the tips in a light, quick, downward motion.
Do not wipe across the bottom of the tip. If
the tips are not wiped, test results may be
inaccurate.
IMPORTANT: If the tip is not wiped, test
results may not be accurate.
7. Check fluid volume.
Visually check the fluid level inside the tip.
If fluid volume is not as shown, dispense
sample, eject tip, and repeat steps 1-6.
• Visually check fluid level in both tips as
shown in the illustration.
• Both tips should have approximately equal
fluid levels.
• If fluid level is not as shown, dispense
sample, eject tips, and repeat steps 1 -6.
NOTE: Inadequate fluid in tip(s) can lead to
errors in test results.
Fluid Level
Check for Air
Space at Tip
NOTE: Inadequate fluid in tip can lead to
errors in test results.
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STEPS
8. Spot the slide.
9. Check pipette tips.
1O.Ejecttip(s)
DT Pipette
For procedures on slide spotting refer to
Section 2.2.2.
Visually check the tip to assure that the fluid
was completely dispensed from the tip. If
fluid is still visible, dispense the fluid into a
tissue and repeat the test with a fresh tip.
IMPORTANT: Never eject a tip that has fluid
in it. Always dispense the fluid completely
before ejecting the tip.
• Press the tip eject lever to eject the used tip.
DTE Pipette
For procedures on slide spotting refer to
Section 2.2.2.
Check that the fluid was completely
dispensed from the tips. If fluid is still
visible, press the button to dispense the
fluid into a tissue.
• Press the latch button to eject the used tips.
• Dispose of tips.
NOTE: Fluid should not be used if it has been
in the dual-sample cup for more than 5
minutes. If so, take a clean dual-sample cup
and pipette fresh fluid.
• Dispose of tip.
NOTE: Use tips only once. Always use a new
tip for each aspiration, even if it is drawn from
the same fluid.
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2.2.2 Steps for Analysis on the VITROS DT II System
STEPS
GENERAL
INFORMATION
1. Warm slides to room
temperature.
This takes approximately
15 minutes
2. Load slides.
Position the slide into the
loading station.
IMPORTANT: Inserting
or removing a slide without
following the analyzer
prompts can cause
unexpected results:
DT60 II System
Manually push the slide
advance lever to move
slide into spotting
station.
DTSC II Module
Manually insert the
slide. It is automatically
carried to the spotting
station.
DTE II Module
Manually push the slide
advance lever to move
slide into the spotting
station.
• Wait until the
"ANALYZER READY"
message appears before
inserting a slide.
• DO NOT remove slide
from spotting station after
insertion unless directed
by the analyzer.
U
cm •
0
See illustrations for
proper insertion of slide.
Rev. 2004-03-30
• Notch in first
• Notch to right
• Notch in first
• Bar code up
• Bar code up
• Bar code down
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2.2.2 Steps for Analysis on the VITROS DT II System (continued)
STEPS
3. Enter patient
identification
(optional).
GENERAL
INFORMATION
DT60 II System
DTSC II Module
DTE II Module
• Analyzer will display
the message (optional)
to enter information
with "1D=".
• To enter any patient
identification number
up to 10 characters,
press the PATIENT ID
key and the numbers or
characters you wish to
enter, then press the
ENTER key.
• If you do not wish an ID
to printout, press the
PATIENT ID and CLEAR
key and then press the
ENTER key.
4. Insert tips onto the
DT Pipette or DTE
Pipette.
Press tips firmly into
place.
• Use 1 new tip.
• Use 1 new tip.
• Use 2 new tips.
5. Aspirate the fluid.
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STEPS
6. Spot the slide.
GENERAL
INFORMATION
• Gently insert pipette(s)
into locator. The pipette
must be fully seated in
the pipette locator.
• Press the Start button to
dispense 10 uL of fluid
onto the slide.
DT60 II System
An audible tone
indicates that the slide
has been spotted.
Remove the DT pipette
from the pipette locator
within one second of
the tone.
• A dotted line will
appear in the display
after which the message
(* R5P] or the message
la will appear in the
display indicating that
the DT Pipette is ready
for the next aspiration/
dispense cycle.
DTSC II Module
Green flashing light
indicates "ready-tospot" status.
At the sound of the tone
promptly remove the
pipette from the locator.
Delay in the removal of
the pipette may result in
inaccuracy and
imprecision.
Rev. 2004-03-30
Always use a new tip(s)
for each sample
analyzed.
• Depress the pipette
button and continue to
hold it depressed. With
the button still
depressed, promptly but
slowly, remove the
pipette from the locator.
• An audible tone will tell
you when the slide has
been spotted.
IMPORTANT: Do not
release the pipette button
until you have removed it
from the pipette locator.
Reaspiration of fluid that
has already been
dispensed on the slide
may occur.
IMPORTANT: DO NOT
remove slide from spotting
station after insertion unless
directed by the analyzer.
7. Eject tip(s).
DTE II Module
• Red indicator light will
flash while slide is
incubating.
Dispose of tip.
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Dispose of tip.
Dispose of tips.
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STEPS
8. Repeat for other
tests.
GENERAL
INFORMATION
Repeat steps 1 -7 for
additional sample
analysis once analyzer
is ready to accept
another slide.
DT60 II System
Display will read
ANALYZER READY.
DTSC II Module
DTE II Module
Display will read DTSC
MODULE READY.
Display will read DTE
MODULE READY.
IMPORTANT TIPS
Allow the slides to reach room temperature before use.
Press tip(s) firmly onto pipette.
Check fluid level in tip(s).
Wipe excess fluid from Ihe oulside of tips.
Handle pipette carefully while aspirating fluid and spotting slide.
Orient slides as shown in illustrations.
Enter the patient ID when prompted by the analyzer. If an ID is nol enlered, [he previous ID that
was entered will print out.
When DT60 il System is turned on, the number 1 is an analyzer-assigned ID number for your
first sample until the operator changes it.
Always follow the analyzer prompts. Wait until the "ANALYZER READY" message appears
before inserting a slide.
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2.3 Calibration Data Module and Chemistry Language Module
2.3.1 Description of Calibration Data Module
The calibration data module (CDM) is an electronic device contained in a protective carrier. The CDM
contains several different types of data required to perform various tests on the DT60 II System and the DTE
II and DTSC II Modules (for example, the generation number and the calibration kit number).
OCD will issue a new CDM when:
1. You receive slides with a new generation number that is not supported in your current CDM. (The
generation number appears on the individual slide wrapper and slide cartons, and on the bottle labels for
Reference Fluid to define a formulation and process of manufacture.)
2. You receive calibrators having a new kit number which is not supported in your current CDM. The CDM must
be installed before you use the new calibrators in order for the instrument to use the correct calibration data.
CAUTION: A CDM is a delicate electronic device. Handle with care.
2.3.2 Description of Calibration Language Module
Like the calibration data module, the chemistry language module (CLM) is an electronic device contained
in a protective carrier. The CLM contains data on the messages that appear on the screen display and
information needed to perform all tests available on the analyzer. Like the CDM, the CLM is designed to
plug into back of the analyzer.
CAUTION: The CLM is a delicate electronic device. Damage can occur. Handle with care.
A new CLM is provided whenever an additional test becomes available unless your current CLM already
contains the test. French, German, and Italian language CLMs are available to non-U. S. customers upon
request.
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2.3.3 How to Install a New Calibration Data Module (CDM) and a Chemistry Language Module (CLM)
Follow the steps outlined below for simple installation instructions for both the CDM and CLM.
STEP
1. Turn the analyzer off.
2. Remove the old C D M or CLM.
ACTION TO TAKE
The analyzer must be turned off before installing
either a new CDM or CLM.
Begin removing the old CDM or CLM by
opening the door on the back of the analyzer to
gain access to the compartment that houses the
CLM and CDM.
Read the labeling on the side of the compartment
to make sure that you are unplugging the correct
component.
Unplug the old CLM or CDM as shown in the
illustration.
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2.3.3 How to Install a New Calibration Data Module (CDM) and a Chemistry Language Module (CLM) (Continued)
STEP
3. Install the new CLM or C D M .
ACTION TO TAKE
• Hold either component by the side edges and
carefully remove it from its packaging.
• Position the new CLM or CDM as shown on the
body of the analyzer. Note the positioning of the
tabs.
• Check the alignment of the carrier to the
receptacle before inserting the CLM or CDM.
• Check the labeling to make sure that you have
inserted the correct component into the correct
receptacle.
• For CLM installation: Calibrate the analyzer for
the new test if you received the CLM with the
materials for the test. If you changed the CLM
only to change the language on the display
screen then there is no need to recalibrate.
NOTE: If the print is jumbled on the printer, the
CLM and CDM may be in the wrong positions.
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2.4 Normal Shutdown Procedure
The analyzer can be left on at the end of each day, however, the DTSC II Module should be turned off at the
end of each day. Turning the analyzer off results in the loss of tests that may remain in the incubator and test
results that have not been printed. Turning the analyzer off has no effect on the instrument's memory, and
does not result in loss of calibration values or loss of other information stored in the memory. Do not have
the DTSC II Module on if the DT60 II System is turned off. When turning the analyzer off, follow the steps
outlined here.
1. Check incubator for tests in progress.
First, check that there are no unread slides in the analyzer through use of the TEST IN PROGRESS/TEST
COMPLETE key.
If the analyzer is connected to a VITROS DTE II Module, check the red indicator on the module. If the
indicator is flashing, wait until the test result is reported and the indicator stops flashing.
2. Turn analyzer off.
When you are sure that all tests are complete, turn off the DTSC II Module. Then turn the DT60 II System off
by moving the main power switch to the OFF position.
2.5 Emergency Shutdown
In case of an emergency, simply turn the main power switch on the DTSC II Module to OFF, then turn off
the DT60 II System. When you turn the analyzer on again, you will have to repeat the analysis for all tests
that remained in the incubator at the time of the shutdown.
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Coronary Risk Classification (CRC)
The analyzer's microcomputer has the ability to perform Coronary Risk Classification (CRC) analysis for the
purpose of determining five- and ten-year coronary risk probabilities. The American Heart Association
(AHA) recognizes this analysis which is based on an update of the coronary risk assessment methodology of
the Framingham Heart Study conducted by the National Heart, Lung and Blood Institute (Anderson, K. M.,
Wilson, P. W. R, Odell, P. M., and Kannell, W. B., "An Updated Coronary Risk Profile," Circulation: Vol. 83,
No. 1Jan. 1991).
This section provides you with instructions for accessing the CRC program, entering the appropriate data
needed to calculate coronary risk probabilities, and printing the five- and ten-year risk probabilities.
3.1 CRC Overview
To develop a coronary risk profile, the AHA recognizes various risk factors including sex, age, cigarette
smoking, high blood pressure, high levels of serum cholesterol, low HDL-cholesterol, diabetes and ECG
abnormalities. Although these are not the only accepted risk factors, they represent information which is
easily available from a doctor's office and is without patient discomfort. Values assigned for each risk factor
are awarded points, based on the relative degree of risk. The sum of all points then determines the CRC fiveand ten-year risk probabilities.
CRC five- and ten-year risk probabilities take into account eight risk factors and should be used as a guide
only. The test does not take into account other risk factors, e.g., obesity, x-ray cardiac enlargement, lack of
physical activity, heredity etc. Furthermore, the probabilities represent average values over a given
population and not necessarily the experience of any one person.
Coronary Risk Classification should be used with other information and parameters available from clinical
patient evaluation. The CRC predictions provide a diagnostic tool, but are not a substitute for the
physician's judgment.
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The CRC program allows the user to input "what if?" values for a given profile in order to determine the
overall effect of that change on the five- and ten-year risk probability. For example, a 55-year-old male
smoker who has a five-year CRC of 22% may see that he can reduce his risk probability to 1 6% if he gives
up smoking. Of course, there is no assurance that lowering any given risk factor will in reality reduce
overall risk. Clinical trials of risk-factor alteration, however, provide positive evidence that improving the
risk-factor profile will lower the risk of coronary disease.
3.2 Entering Data for Coronary Risk Classification
1 . Access the CRC option
Press SHIFT, then SERVICE/CAL MODE. When the display prompts you to ENTER OPTION NO., key in
option 24 and press ENTER to create, enter and modify CRC records.
You may only enter this option if there are no samples processing. If samples are processing, the analyzer
will beep and display WAIT - TESTS IN PROGRESS until it completes the test.
2. Enter Patient ID
At the CRC ENTER PATIENT ID prompt, the current CRC record in memory will be displayed if one exists.
You have three choices:
• Press ENTER if you wish to use the patient ID currently displayed.
• Key in up to 1 0 characters and press ENTER if you wish to enter a new patient ID. You cannot change the
patient ID, once it has been entered.
• Press the PATIENT ID key if you wish to use a patient ID in memory other than the patient ID currently
displayed.
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3.2 Entering Data for Coronary Risk Classification (continued)
The CRC program allows you to maintain CRC records for up to three different patient IDs at one time. If a
fourth record is created, it replaces the oldest of the three existing CRC records. When you attempt to create
a fourth record, the analyzer will tell you if the oldest record has not been reported.
CRCxxxxxxxxxNOT REPORTED
DELETE TEST TO REPLACE
It will identify the patient ID that will be replaced and will give you two options.
1. Replace the oldest record with the new patient ID by pressing SHIFT and DELETE TEST.
2. Return to the CRC ENTER PATIENT ID prompt with no replacement. To do this press ENTER.
You may also print from the patient ID screen. Touch PRINT for a printout of the CRC report. The analyzer
will indicate which, if any, data is missing. It will not generate a coronary risk classification until all
information needed to calculate the test has been entered.
3. Enter Sex
Key in 0 for female or 1 for male, as appropriate. Press ENTER.
If you are working with an established record and do not wish to make a change, press ENTER to continue.
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4. Enter Age
Enter the current age of the patient and press ENTER.
The program is based on an age range of 30 to 74 years. If an age is entered that is less than 30, the program
will accept the value but will automatically set that age value to 30; similarly, if an age is entered that is
greater than 74, the program will set that age value to 74. Any data modified by CRC program in this way
will be noted with both a plus sign (+) next to the age and by the words "DATA SET TO AHA CHART
LIMITS" on the printed CRC report.
5. Enter Systolic Blood Pressure
Enter the systolic blood pressure of the patient and press ENTER.
If an SBP value is less than 98 or greater than 185, the program will accept the value but will automatically
set that value to 98 or 185, respectively. When the SBP field is modified this way, a plus sign (+) and the
words "DATA SET TO AHA CHART LIMITS" will appear on the printed CRC report.
SBP measurements should be taken with the patient seated. The average of at least two readings is
preferred.
If you are working with an established record and do not wish to make a change press ENTER to continue.
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6. Enter Smoker or Nonsmoker
Enter 0 if the patient is not a smoker and has not smoked for the past 12 months. Enter 1 if the patient is a
smoker or has quit smoking within the past 12 months. Once your selection is made, press ENTER.
NOTE: The program is based on data which does not address the "degree" of smoking, i.e., heavy smokers
and light smokers. A distinction is made only between smokers and nonsmokers.
7. Enter Diabetic or Nondiabetic
Enter 0 for nondiabetic or 1 for diabetic, whichever is appropriate, and press ENTER.
For purposes of coronary risk assessment, the program defines a diabetic patient as one who is currently
under treatment with insulin or oral hypoglycemic agents OR who has a fasting glucose level of 140 mg/dL
or greater.
8. Enter ECG-LVH
Enter 0 if the patient tests negative for left-ventricular hypertrophy by ECG. Press 1 if the patient tests
positive. Press ENTER to continue.
LVH-ECG consists of finding tall R-waves in leads reflecting potentials from the left ventricle. The R-waves
are accompanied by nonspecific S-T or T-wave abnormalities.
Enter 0 for ECG-LVH to get a rough estimate of a person's coronary risk classification, when ECG data are
unavailable. It should be recognized, however, that in a small fraction of people the CRC assessment will
be inappropriately low since ECG-LVH is a strong risk factor when it is reported as positive. See the CRC
Supplement for further information.
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9. Enter CHOL value
There are 3 approaches to entering the CHOL and HDLC values.
1. You may run up to 10 CHOL tests and 10 HDLC tests (the analyzer has the capacity to remember the
results for 20 tests) and then enter the corresponding CRC data for those 10 patients. After a complete set
of data is stored for a patient, you may successfully request a printout of the Coronary Risk Classification
results.
2. You may enter the CRC data for up to three patients at a time, then run the CHOL and HDLC tests. The
analyzer will automatically printout the CRC results after printing the results for the chemistry tests.
3. You may run the CHOL and HDLC tests and keep a record of the test results for input into the CRC option
at a later time. This allows you to run the CRC tests at your convenience and not worry about the 20result capacity in the buffer.
Assuming the CHOL test was run on the patient sample previous to entering CRC data, the cholesterol
value will automatically be displayed on the analyzer screen. If the screen is blank, the CHOL value needs
to be entered. Once the data has been computed and printed, you may enter a new CHOL value replacing
the current value or alter other risk parameters, permitting you to conduct "what if?" tests.
NOTE: Values that printout GREATER THAN ANALYZER RANGE will not be included in the 20 report
buffer. Once the sample has been diluted it will not be considered multiple. The analyzer will
automatically print a result based on the diluted sample. The CHOL value must be multiplied by two and
entered into the data to replace the current (diluted) value. You will receive an incorrect CRC result if the
data is not modified.
Both CHOL and HDLC require manual entry if either was multiple within the last 20 results. In this case,
the word MULTIPLE will be displayed on the screen. Enter the appropriate CHOL value. The printed CRC
report will be marked with an asterisk (*) next to the value indicating that the value was manually entered
or "User Modified" and with a pound sign (#) indicating multiple results. Both CHOL and HDLC will be
marked as multiple if either was multiple.
If a CHOL value is less than 139 mg/dL or greater than 330 mg/dL, the program will accept the value but
will automatically setthat value to 139 mg/dL or 330 mg/dL, respectively. When the CHOL field is modified
in this manner, a plus sign (+) and the words "DATA SET TO AHA CHART LIMITS" will appear on the
printed CRC report.
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10. Enter HDLC value
As mentioned in step 9, there are 3 approaches to entering HDLC values.
If the screen is blank, the HDLC needs to be run or the value entered manually.
If an HDLC value is less than 25 mg/dL or greater than 96 mg/dL, the program automatically sets that value
to 25 mg/dL or 96 mg/dL, respectively. When the HDLC field is modified in this manner an asterisk (+) and
the words "DATA SET TO AHA CHART LIMITS" will appear on the printed CRC report.
NOTE: If all other criteria are in the analyzer memory and the HDLC has been pre-diluted, the analyzer will
automatically print a result based on the diluted sample. The HDLC value must be multiplied by two and
entered into the data to replace the current (diluted) value. You will receive an incorrect CRC result if the
data is not modified.
If you tend to manually enter your results, make sure you multiply the diluted value by two when entering
the number. If you enter the CRC data after running the tests, make sure you modify the HDLC data before
requesting a CRC report.
3.3 Printing CRC Results
Press PRINT if you wish to have the keyed-in values computed and a coronary risk classification report
printed. The printed report lists the CRC values you entered for each field along with the five- and ten-year
risk factors and it prints the peer average for 10-year risk within the appropriate gender.
If all CRC data is available but the computed CRC total point value exceeds the American Heart Association
chart maximum of 32, the following message will be printed to finish the CRC printout:
************************
AHA CHART EXCEEDED
**** ********** **********
Press ENTER if you wish to return to the PATIENT ID prompt to add missing data or modify data before
printing.
The program will be unable to calculate the five- and ten-year risk probability if any field of information is
missing. Note the meaning of certain indicators that may precede entered data (see sample CRC reports on
next two pages):
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3.3 Printing CRC Results (continued)
plus sign (+)
DATA SET TO AHA CHART LIMITS.
Indicates that the entered value was not within the limits set by the program.
Subsequently, the program modified the entered value.
asterisk (*)
USER MODIFIED.
• Data was modified after the CRC report was printed, e.g. smoker vs. nonsmoker.
• It also indicates a CHOL or HDLC value was entered manually AND the manual
entry was made prior to printing the CRC report.
pound (#)
MULTIPLE RESULTS.
Indicates that multiple results were found for either CHOL and/or HDLC prior to
printing the CRC report. Both are marked a multiple if either had multiple results prior
to printing.
12. Press SHIFT, then SERVICE/CAL MODE to exit option 24.
13. Press SHIFT, then SERVICE/CAL MODE again to exit the service mode.
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1. CHOL & HDLC report, followed by CRC prediction and user-modified
CRC prediction.
*******************
I.D:
99-04-91
*******************
CHOL
HDLC
46 MG/DL
**•••******•***•***
CRC
-^ ^ ^ ^^ ^ -^ ^^ V ^ V V V V ™ ^^ ^^ ^^ ^^ ^p
PT ID
190
FEMALE
45 VEARS
118 MM HQ SBP
SMOKER
NON-DIABETIC
ECG-LVH NEGATIVE
CHOL 239 MG/DL
HDLC
5 VR RISK
46 MG/DL
3"-:
10 VR RISK 6":
AVERAGE 19 VEAR
RISK FOR FEMALE
45-49 VEARS:
5>.
*******************
*******************
2. Age and SBP were set to AHA chart limits
*"*** ** *%*~¥**Ni*y<***y
I.D:
5
89-04-91
******** ***********
CHOL
*******************
MODIFIED CRC
*******************
PT ID
190
FEMALE
45 VEARS
113 MM HS SBP
* NON-SMOKER
NON-DIABETIC
ECG-LVH NEGATIVE
* CHOL
189 MG/DL
HDLC
46 MG/DL
*
USER MODIFIED
5 VR RISK
IS
19 VR RISK
2m<
AUERAGE 10 VEAR
RISK FOR FEMALE
45-49 VEARS: 5'<
*******************
*******************
HDLC
45 MG/DL
*******************
CRC
*******************
PT ID
=
FEMALE
+ 74 VEARS •
+ 185 MM HG SBP
NON-SMOKER
NON-DIABETIC
ECG-L'JH NEGATIVE
CHOL 163 MG/DL
HDLC
45 MG/DL
+
DATA SET TO
CHART LIMITS
5 VR RISK b'-i
19 VR RISK 13'-.
AVERAGE 10 VEAR
RISK FOR FEMALE
76-74 VEARS: 12X
*******************
*******************
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3. Multiple reports for CHOL and/or HDLC
followed by CRC report with manual
entry of CHOL and HDLC.
*******************
CRC
*******************
PT ID
19
FEMALE
37 VEARS
12@ MM HG SBP
SMOKER
NON-DIABETIC
ECG-LVH NEGATIUE
#CH0L MULTIPLE
#HDLC MULTIPLE
# MULTIPLE RESULT
MISSING CRC DATA
*******************
*******************
*******************
MODIFIED CRC
*******************
PT ID
10
FEMALE
Z7 VEARS
120 MM HG SBP
SMOKER
NON-DIABETIC
EC6-LUH NEGATIUE
*#CH0L 174 MG/DL
*#HDLC
59 M6/-DL
*
USER MODIFIED
# MULTIPLE RESULT
5 VR RISK
10 VR RISK <2'/.
4. CHOL and HDLC followed by CRC
report indicating risk factors were
greater than AHA Chart Limits.
*******************
1.0:
15
09-94-91
*******************
CHOL
231 ItQ/DL
HDLC
45 MQ/DL
*******************
CRC
*******************
PT ID
It
FEMALE
72 YEARS
131 MM HG SBP
SMOKER
DIABETIC
ECS-LUH POSITIUE
CHOL 231 MG/DL
HDLC
45 MQ/DL
5. CRC report requested without all
information needed to make prediction.
*******************
CRC
*******************
PT ID
2?
MALE
48 VEARS
119 MM HG SBP
NON-SMOKER
DIABETIC
ECG-LUH NEGATIUE
CHOL MISSING
HDLC MISSING
MISSING CRC DATA
*******************
*******************
*******************
AHA CHART EXCEEDED
*******************
*******************
AVERAGE 10 VEAR
RISK FOR FEMALE
35-39 VEARS: <i\
*******************
*******************
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Derived Tests
The VITROS DT II System has the ability to calculate derived tests based on the results of related chemistry
components.
This section describes how to access the options for derived tests, how to process derived tests, and how to
print derived test results.
3.4 Overview
Derived test processing is available for:
1. Globulin (GLOB) and the Albumin-Globulin Ratio (A/G). Calculations are derived from ALB and TP test
results.
2. Very low density lipoproteins (VLDL), low density lipoproteins (LDL) and the cholesterol/high density
lipoprotein cholesterol ratio (CHOL/HDLC Ratio). These tests are collectively called the Lipid
Calculation. Calculations are derived from CHOL, HDLC and TRIG test results.
3. Anion gap (AGP). This calculation is derived from Na + , Cl" and CO 2 test results.
For derived test processing to occur, the following conditions must be met:
• The derived test must be turned on by selecting the appropriate Option number prior to running tests on
the component chemistries.
• Ajj of the components required to calculate the derived test result must be within the last 20 tests
reported.
• There must be no more than one test result stored in the analyzer for the component and patient ID just
tested. No multiple results are allowed.
IMPORTANT
To assure completion and accuracy of derived test processing:
• Component chemistry values must not be based on a dilution factor.
• A 1-10 character patient ID must be entered for the component tests prior to spotting the necessary
slides with fluid.
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3.5 GLOB and A/G
These derived tests are calculated from ALB and TP test results as follows:
GLOB
A/C
TP-ALB
ALB/GLOB
To access globulin and the albumin/globulin processing:
• Press SHIFT, then SERVICE/CAL MODE to enter the service mode.
will beep and display - WAIT - TESTS IN PROGRESS until it completes all tests.
• When the display prompts you to ENTER OPTION NO., key in 25 and press ENTER.
• Press 1, then ENTER to turn on GLOB and A/G Ratio derived test processing.
• Press SHIFT, then SERVICE/CAL MODE again to exit the service mode.
Now you are ready to run the component tests as outlined in section 2 of this manual, Operating
Instructions.
Once the patient ID is entered and both the ALB and TP slides are analyzed, GLOB and A/G test results will
automatically be calculated and printed along with the ALB and TP test results.
If more than one value for ALB or TP for a given patient ID appears in the last 20 results buffer, the test
name and MULTIPLE RESULTS Will appear on the printout followed by the name of the derived test and NO
RESULT-COMPUTE MANUALLY.
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3.5 GLOB and A/G (continued)
To turn globulin and the albumin/globulin processing off:
• Press SHIFT, then SERVICE/CAL MODE.
• Press 0 to turn off GLOB and A/G derived test processing.
1. Results from component tests, ALB and
TP, followed by GLOB and A/G results.
2. A 1-10 character patient ID was not
entered prior to running ALB or TP tests.
*******************
I.D:
5154
81-20-92
*******************
ALB
3.0 8/DL
61-28-92
* ft**************
ALB
Z.B
TP
TP
4.5 G/DL
*******************
I.D:
5i5d
TP
4.5 G---DL
ALB
3.0 G/DL
GLOB
1 . 5 6/-DL
A/G
2.0
*******************
3. The analyzer cannot calculate results for
GLOB or A/G if there are multiple results
for either of the component tests.
1,1
***
*.***,-,
1
* : : • . * * * * * * • * * * * *
8..: •j-'DL
TP
j,'DL
3.6
*******************
I.D!
TP
BLANK PATIENT ID
ALB
HQ RESULT
COHPUTE HAHUALLV
*******************
Tp
5. i
j/DL
* * * * x * »: * * * * * * * * * * * *
I.D:
1
HL'-'.PLE RESULTS
GLOB,A,G HO
RESULT
COMP.Ti MANUALLV
****:/*:yt
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* * * * * * * * * * * *
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3.6 Lipid Calculation (VLDL, LDL and CHOL/HDLC Ratio)
These derived tests are calculated from TRIG, CHOL and HDLC test results as follows:
VLDL
=
TRIG/5.0
(Conventional units)
TRIG/2.2
(SI units)
LDL
=
CHOL-HDLC-VLDL
CHOL/HDLC ratio
=
CHOL/HDLC
To access VLDL, LDL and CHOL/HDL Ratio processing:
• Press 1, then ENTER to turn on the lipid calculation derived test processing.
Instructions.
Once the patient ID is entered and CHOL, HDLC and TRIG slides are analyzed, VLDL, LDL AND CHOL/
HDLC ratio results will automatically be calculated and printed along with the CHOL, HDLC, and TRIG
test results.
If more than one value for CHOL, HDLC or TRIG for a given patient ID appears in the last 20 results buffer,
the test name and MULTIPLE RESULTS will appear on the printout followed by the name of the derived test
and NO RESULT-COMPUTE MANUALLY.
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3.6 Lipid Calculation (VLDL, LDL and CHOL/HDLC Ratio) (continued)
VLDL and LDL will not be calculated if the TRIG value is greater than or equal to 400 mg/dL (4.52 mmol/L).
In this case, the error message NO RESULT TRIG TOO HIGH will be printed.
To turn the lipid calculation derived test processing off:
• Press 0, then ENTER to turn off the lipid calculation derived test processing.
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3.6 Lipid Calculation (VLDL, LDL and CHOL/HDLC Ratio) (continued)
1. Results from component test, TRIG,
followed by the VLDL result.
Results from component tests, CHOL and
HDLC, followed by LDL, VLDL and
CHOL/HDLC results.
*******************
I.D:
78816
01-28-92
*******************
TRIQ
125 MG-'DL
*******************
I.D:
78916
TRIG 125 MQ/DL
ULDL
25 PfG/DL
*******************
*******************
CHOL
163 MQ/DL
HDLC
65 MG.'DL
*******************
I.D:
70816
TRIG
CHOL
HDLC
125 MS/DL
163 MG/DL
65 WG/DL
entered prior to running CHOL, HDLC,
or TRIG.
*******************
I. o;
01-20-92
* * * * ******** * * * * * * *
CHOL
160 CIG-'DL
HDLC
66 riG.-'DL
* * * * * * * :f * * * * * * * * * * *
I.D:
2 "5
61-24--92
*******************
CHOL
232 MG.'DL
CHOL
234
Mi
*******************
I.D:
HDLC
BLANK PATIENT ID
TRIG
Cv-H,LDL HO R E S U L T
COMPUTE MANUALLV
***•***********+***
*******************
I.D:
25
TRIG 255 MS/DL
TRIG
128 TIQ/OL
ULDL
51 MG-'DL
•fc*****************
*******************
*******************
I. D :
TRIG
BLANK PATIENT ID
HDLC
52 f1G-'0L
ULDL,LDL NO RESULT
COMPUTE MANUALLV
*******************
255 MG/DL
*******************
I.D:
25
CHOL
MULTIPLE RESULTS
C / H , L D L HO RESULT
COMPUTE MANIJALLV
*******************
LDL
73 MQ^DL
ULDL
25 MG/DL
CHOL-'HDL RATIO 2.5
*******************
LDL, VLDL, or CHOL/HDLC if there are
multiple results for any of the component
tests.
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3.7 Anion Gap (AGP)
This derived test is calculated from Na + , CI" and CO 2 test results as follows:
AGP =
Na+-(Cr
To access AGP processing:
• Press 1, then ENTER to turn on AGP derived test processing.
Instructions.
Once the patient ID is entered and Na + , CI" and CO 2 slides are analyzed, the AGP result will automatically
be calculated and printed along with the Na + , CI" and CO 2 test results.
If more than one value for Na + , CI" or CO 2 for a given patient ID appears in the last 20 results buffer, the test
name and MULTIPLE RESULTS will appear on the printout followed by the name of the derived test and NO
RESULT-COMPUTE MANUALLY.
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3.7 Anion Gap (AGP) (continued)
To turn anion gap processing off:
• Press 0, then ENTER to turn off the AGP derived test processing.
1. Results from component test, Cl", CO 2 ,
+
and Na , followed by AGP result.
01-29-92
*******************
CL-
Sl MMOL-'L
entered prior to running Cl", CO 2 , and
Na + tests.
*******************
I.D:
61-20-92
*******************
AGP if there are multiple results for any
of the component tests.
* f * -i- .«•• i- ,: * * * * * * * *
I.D:
* * .* *
2
* :f * f •-: •
* * * * * * * * * * * *
CL12:
.iMOL-'L
UL-
32 MMOL/L
121
C02
25 riMOL/L
HA+
119 MMOL/L
*******************
I.D:
NA+
CLC02
A8P
484243
119 MMOL-'L
81 MMOL.-'L
25 PHIOL-'L
13 MMOL-'L
H e * * * * * * * * * * * * * * * * * *
C02
22
COX
:M0L/L
NA+
119 MMOL/L
*******************
I.D:
NA+
BLANK PATIENT ID
AGP NO RESULT
COMPUTE MANUALLV
*******************
NA +
***y- i .
AGP ..: RESULT
COM? W T £ M H N U A L L V
* * • * .
Operator's Manual
VITROS DT II System
. * * * * * * * * * * * *
I.D:
2
CLMl'-'-PLE RESULTS
. * . • , • : * * * * * * * * * * * *
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Calibration
Calibration of blood-chemistry analysis equipment is an extremely important part of good laboratory
procedure, since calibration helps to ensure the accuracy of test results. Faulty calibration — or failure to
calibrate the VITROS DT60 II System when recommended — can lead to erroneous test results.
When you calibrate the DT60 II System, you are programming new information into the software that
translates data gathered during a slide reading into test results. Thus, during calibration, you are establishing
new parameters for this translation process.
The actual calibration procedure involves the analysis of VITROS calibrators — fluids with known analyte
concentrations — in much the same manner as you analyze patient samples. Unlike sample analysis,
however, the entire calibration procedure takes place with the System in the calibration mode, rather than
the run mode.
This procedure has been designed with ease and flexibility in mind. For instance, while it is suggested that
you calibrate the tests in a certain order to make sure you do not miss any of them, you are free to calibrate
in any order you wish. Thus, you can rearrange this procedure to meet your special needs.
4.1 Why You Need to Calibrate
Periodic calibration of the DT60 II System is required to maintain instrument reliability.
As you calibrate, the analyzer establishes calibration parameters used to translate the response of the
analyzer into concentrations of a desired analyte. These parameters, which are printed out at the
completion of the calibration process, are stored in the analyzer's microcomputer memory.
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4.2 When to Calibrate
Calibration is crucial to the ongoing reliability of your test results. CALIBRATE THE ANALYZER FOR ALL
TESTS:
1. When the analyzer is initially installed.
2. When government regulations require.
- For example, in the USA, CLIA regulations require calibration or calibration verification at least once every
six months.
3. When your Field Engineer indicates that calibration is necessary because servicing procedures might
have affected the validity of the stored calibration parameters.
Calibrate the analyzer for individual tests:
1. When the lot number of the ViTROS DT Slides change.
2. When the results of a quality control test using VITROS DT Controls or VITROS DT Isoenzyme Controls
are consistently outside an acceptable range.
3. When a new lot of VITROS DT Reference Fluid is used. (This requires recalibration of tests run on the
DTE II Module only.)
NOTE: Refer to Section 13, "Log Sheets," for a sample of calibration log sheets to record data.
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4.3 How to Calibrate
The major steps in the calibration procedure are: preparing the calibrators, analyzing them on the
instrument, and assaying quality control fluids. Refer to the chart provided in this section for procedural
steps on calibration.
The procedure for analyzing the calibrators is designed to be simple and straightforward. In fact, it is very
similar to the procedure used to analyze patient samples. However, the analyzer operates in the calibration
(CAL) mode and analyzes the concentration of VITROS DT calibrators rather than patient samples.
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4.3.1 Preparing VITROS DT Calibrators
Calibrators needed for the DT60 II System are generally lyophilized materials that need to be reconstituted
and used as soon as possible. Refer to the instruction sheet packaged with the product for reconstitution
procedures and storage and stability requirements.
STEP
ACTION TO TAKE
1. Allow calibrators to warm to room
temperature.
• Allow at least 30 minutes for frozen calibrators
and diluents.
2. Open bottles.
• Remove metal seal from each bottle just before
you intend to use them.
IMPORTANT: DO NOT allow the diluents to stand
without the stoppers.
3. Reconstitute the calibrators.
• Tap the top of each bottle so that any lyophilized
materials adhering to the inside of the rubber
stopper drop down into the bottle.
• Add exactly 3.0 mL of the appropriate diluent to
each vial of lyophilized calibrator.
• Use a new 3.0 mL pipette tip for each diluent.
• Discard any remaining diluent.
IMPORTANT: DO NOT interchange calibrators
and diluents.
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4.3.1 Preparing VITROS DT Calibrators (continued)
STEP
4. Dissolve all lyophilized particles.
ACTION TO TAKE
Allow calibrators to stand for 30 minutes.
Slowly invert the diluent bottles several times to
mix the contents thoroughly. Swirl bottles
periodically, but DO NOT SHAKE the bottles.
Invert the bottles slowly to dissolve the
lyophilized particles.
• All particles must be dissolved before using.
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4.3.2 Entering the Calibration Mode
STEP
ACTION TO TAKE
1. Allow the slide to warm to room
temperature.
This takes approximately 1 5 minutes.
2. Enter the calibration mode.
Press the CAL key. The word CAL will appear in the
upper right hand corner of the display.
3. Enter the calibrator kit number.
• The display will prompt you ENTER
CALIBRATOR KIT NUMBER.
• Enter the kit number that is printed on the carton
containing the calibrators, then press the ENTER
key.
4. Enter the generation number of the
Reference Fluid.
• Enter the generation number found on the label
of Reference Fluid, then press the ENTER key.
• If you do not have reference fluid, then enter 01
and press the ENTER key.
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4.4 Calibration
STEPS FOR CALIBRATION O N THE VITROS DT II SYSTEM
STEP
GENERAL INFORMATION
1. Push slide into spotting station.
• Run bottles in sequence.
• The display will prompt you which bottle
numbers to use.
• Enter calibrator bottle number by pressing the
bottle number and ENTER key.
IMPORTANT: DO NOT insert slide until DT60
indicates "ANALYZER READY".
IMPORTANT: DO NOT remove slide from spotting
station after insertion unless directed by the analyzer.
2. Insert and fill dual-sample cup.
DTE II Module only.
See Section 2 for specific instructions.
• For specific instructions on proper pipetting
techniques see Section 2.
3. Aspirate calibrator fluid.
• Carefully place pipette into calibrator bottle.
DT60 II
and
DTSC II
• Aspirate fluid.
• Check fluid volume as shown in illustrations.
Fluid Level
Check for Air
Space at Tip
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4.4 Calibration (continued)
STEP
GENERAL INFORMATION
Carefully position pipette in locator.
4. Spot slide.
IMPORTANT: DO NOT remove slide from
spotting station after insertion unless directed by the
analyzer.
DT60 I I System
• With the pipette in the locator, depress and
release the start button.
• An audible tone indicates that slide is spotted
and you should then remove the pipette from
locator.
DTSC II Module
• A green flashing light and an audible tone
indicate a "ready-to-spot" status.
• When spotting is completed the green light will
go off.
DTE II Module
• Depress the pipette button and continue to hold
it depressed. With the button still depressed,
slowly remove the pipette from the locator.
• An audible tone will tell you when the slide has
been spotted.
• A flashing red light appears to indicate
incubation has begun.
DTE II Module
5. Eject tips.
• Discard dual-sample cup after each bottle.
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STEP
GENERAL INFORMATION
6. Repeat steps 1-5 for the same test using the
next bottle.
Flashing numbers on the display indicate the
bottles which have been run for a particular test.
7. Examine test results.
• Printout should read as follows:
* 1 REP # 1
• The number after the * is the bottle number, and
the number after the # is the successful replicate
completed.
IMPORTANT: if a slide is not processed
successfully on the first rep during calibration, a
zero is reported instead of a valid replicate number
(for example, * 1 REP # 0). If this happens, run
another slide for the same test using the bottle
number indicated on the display screen.
8. Repeat steps 1 through 7 for other tests.
Operator's Manual
VITROS DT II System
Before exiting the calibration mode, be sure there
are no printout messages which report a zero (0)
instead of a valid replicate number.
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STEP
9. Exit calibration mode.
GENERAL INFORMATION
• Press CAL key.
• If you accidentally forgot to run a bottle (for
example, * 1 REP # 0), the display will read:
TEST MISSING BOTTLES
LOAD "TEST" OR PRESS
CAL TO EXIT.
• Rerun missing bottle if indicated.
• If you do not run the bottle indicated, the test
will not be calibrated.
• Press CAL key a second time to exit cal mode.
• Date and save calibration printout, label with 12digit slide lot #.
***************
CALIBROTION
GLU
CP*1-5.6943
CP#2 106.9S
CP#3 2.3413
***************
***************
CALIBRATION
URIC
CPK1-1.8474
CP#2 12.551
CP#3 1.581S
***************
***************
CALIBRATION
K+
CFB1 1.2825
CP#2 .016945
***************
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STEPS FOR CALIBRATION ON THE VITROS DT II SYSTEM
GENERAL INFORMATION
STEP
• Refer to Section 6.
10. Run a quality control test.
IMPORTANT TIPS
Warm slides and calibrator fluids to room temperature.
Do not interchange calibrators and diluents.
For tests run on the DTE II Module, it is recommended that you run each bottle twice.
Examine printout results.
Run a quality control test to verify calibration.
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Instrument Care and Cleaning
Your VITROS DT60 II Chemistry System is designed to keep routine care and cleaning to a minimum. Since
all analyses take place within VITROS DT Slides, there are no liquid reagents to mix or dispose of and
fewer opportunities for messy spills. The self-contained nature of the analysis method also minimizes the
need to clean the internal parts of the equipment.
In short, the analyzer is not a demanding piece of equipment, but it does require some simple care to keep
it operating reliably.
The dry chemistry technology employed by DT Slides and the design of the DT60 II System, DTE II Module,
and the DTSC II Module combine to minimize the need for care and cleaning. However, attention to daily
and weekly cleaning, along with good housekeeping practices (keeping the analyzer and surrounding work
areas as clean as possible, wiping up spills on the analyzer surface as soon as they occur) are
recommended to provide for the continued optimum performance of your equipment.
CAUTION: Routine cleaning does not necessitate opening the analyzer's main cover.
Do not remove main cover or clean analyzer, DTE II Module or the DTSC II Module with ammonia or
ammonia-containing compounds.
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5.1 Daily Cleaning
WHAT TO CLEAN
1. Slide disposal box(es).
HOW TO CLEAN
• Lift out box(es) from analyzer and modules.
• Wash box(es) in a dilute solution of sodium
hypochlorite — for example, a 10% solution of
liquid household bleach, or autoclave the
box(es).
• Replace box(es) after cleaning.
NOTE: Please refer to the VITROS DT Pipette User's Guide for information on cleaning and charging the
DT Pipette.
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5.2 Weekly Cleaning
Clean the analyzer and modules as outlined here. You may use these same procedures when you detect
accumulated dust or serum contaminants on the equipment during normal operation.
Cleaning the DT60 II System
WHAT TO CLEAN
1. Pipette locator and visible slide track area.
HOW TO CLEAN
Clean the pipette locator and all visible slide
track areas with a cotton swab moistened with
water.
Pipette
Locator
Slide
Track
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Cleaning the DT60 II System (continued)
H O W TO CLEAN
WHAT TO CLEAN
2. Bar code reader and drop detector surfaces.
• Put your thumb in the hole at the front of the
analyzer spotting station cover and lift up to
expose the internal assemblies.
• Use lukewarm water and a clean, dry cotton
swab to clean the surfaces. When cleaning is
complete close the spotting station cover.
Bar Code
Reader
Drop
Detector
Sensor
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Cleaning the DTE II Module
WHAT TO CLEAN
1. Pipette locator and visible slide track area.
HOW TO CLEAN
Clean the pipette locators at the aspiration and
spotting stations and the visible slide track areas,
with a clean, cotton swab moistened with water.
After cleaning, dry the area with another swab.
Pipette
Locator
Slide Track
Pipette
Locator
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Cleaning the DTE II Module (continued)
WHAT TO CLEAN
HOW TO CLEAN
Remove the pipette locator by placing your hand
on the module and your thumb under the pipette
locator slot. Lift the pipette holder up and out.
2. Rubber boot on the front of the electrometer.
Remove the nose assembly by turning the screw
counterclockwise.
Inspect and clean nose assembly and rubber
boot with distilled water, then dry with lintless
tissue. Place back into position and tighten
screws clockwise.
1
Replace the pipette locator by placing the locator
at an angle and placing the tabs on the square
holes. Pull up slightly and push in and
downward at the same time.
Electrometer
Nose Assembly,
Removed
Top View
Screw
Bottom View
Electrometer
Assembly
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Rubber Boot
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Cleaning the DTSC II Module
WHAT TO CLEAN
HOW TO CLEAN
1. Pickup and slide spotting stations.
• Clean these stations with a clean, absorbent
cloth moistened with water. Dry them with a
cloth after cleaning.
2. Slide track.
• Raise the access cover of the module to expose
the internal parts.
• Remove the pipette locator.
• Use water and a clean absorbent cloth to clean
the length of the slide track. Dry the slide track
after cleaning.
Slide
Spotting
Station
Pickup Station
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Cleaning the DTSC II Module (continued)
WHAT TO CLEAN
3. Pipette locator.
HOW TO CLEAN
• Use water and a swab to clean the hard-to-reach
areas.
• Carefully replace the pipette locator.
Disassembled Pipette
Locator
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Cleaning the DTSC II Module (continued)
HOW TO CLEAN
WHAT TO CLEAN
4. White reference cap and sapphire read
window.
The white reference cap is located on the
underside of the read station preheater arm. Use
warm water and a clean, absorbent cloth.
The sapphire read window is directly beneath
the read station arm. Use warm water and a
clean, absorbent cloth to clean the window.
White
Reference
Cap
Sapphire Read Window
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5.3 Other Cleaning: VITROS DT60 II Chemistry System FORS Head
Cleaning of the fiber optics reflectance system (FORS) head in the analyzer is recommended prior to
recalibration and when dust is present. The analyzer will prompt you with one of the error codes R11-R1 7
to notify you of the necessity to clean.
WHAT TO CLEAN
FORS HEAD
HOW TO CLEAN
Put your thumb in the hole at the front of the
analyzer's spotting station cover, and lift it to
expose the internal assemblies. To expose the
FORS head, lift up on the weight that covers the
head and rotate it out of the way.
Clean with a cotton swab moistened with water.
Dry with a fresh cotton swab. Remove all lint.
Return the weight into position over the FORS
head and close the spotting station cover.
Weight
Covering
FORS Head
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5.4 Paper Loading
5.4.1 Removing the Paper
STEP
ACTION TO TAKE
1. Remove printer cover.
• Position your thumb on the top of the cover and
your fingers along the bottom edge of the cover
where it joins the left side of the analyzer. Pull it
up firmly and away from the analyzer.
2. Remove paper core.
• Slide the paper core out of the printer cradle and
cut the paper tape at any point between the core
and the slot where the paper enters the printer.
• After the tape is cut away from the core, remove
the remaining tape by pulling it out through the
print head.
CAUTION: Remove the paper with a forward
motion only. Reverse motion can damage the
feeder.
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5.4.2 Inserting Paper
STEP
ACTION TO TAKE
Cut both corners of the edge.
1. Load new roll.
Position paper roll as shown in illustration.
Load paper into the printer cradle keeping the
paper in the same position so that it feeds from
the bottom of the roll.
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5.4.2 Inserting Paper (continued)
STEP
2. Feed paper into print head.
ACTION TO TAKE
Feed paper over the roller and through the slot in
the back of the print head.
Feed the paper until you feel resistance, a sign
that the paper has engaged in the pressure roller
of the print head.
3. Advance paper.
Press the PRINT key to feed the paper through
the print head.
If the paper does not feed through the print head,
try feeding it through the slot in the back of the
print head again, or it may be necessary to turn
the DT60 II System off and back on again to reset
the printer.
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STEP
4. Replace printer cover.
ACTION TO TAKE
• Make sure that the paper feeds out through the
slot between the printer cover and the rest of the
analyzer surface.
• Manually feed the paper through the tear bar and
paper cover.
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STEP
5. Check printer operation.
ACTION TO TAKE
Press the SHIFT key and then the SERVICE
MODE key to enter the service mode.
When the display prompts you to enter an
option, enter Option 4.
When the character set has printed out, press the
SHIFT and SERVICE MODE key again to exit the
service mode. The analyzer then returns to run
mode.
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Quality Control
Reporting reliable patient test results can be assured through a
comprehensive quality control program. Like calibration, regular
quality control testing is an important part of laboratory procedures,
playing a vital role in maintaining the accuracy of test results.
6.1 What Is Quality Control?
Quality control is a means of monitoring the precision and accuracy
of the performance of an analytical system. In a clinical laboratory,
an analytical system consists of: operators' techniques, the
instrument, the reagents (for example, the slides), the calibrators and
the environment of the laboratory, (for example, temperature and
humidity). Precision is the reproducibility of a test and accuracy is a
description of how closely your test results agree with the true value
of the analyte being tested.
Quality control verifies the success of a calibration and allows you to
monitor the long-term performance of the equipment.
There are two primary elements in maintaining quality control (QC).
• Monitoring of the control results
• Following generally accepted lab procedures
6.2 What Are Controls?
Controls contain known amounts of the same analytes that the
analyzer measures in actual patient samples. This allows you to
compare the results the analyzer delivers with known values.
If controls fall within an acceptable range, patient samples may be
analyzed with confidence.
6.3 How Often Should Controls Be Run?
Local regulations may indicate both the number of and frequency
with which you are required to run controls. Analyzing controls daily
will assist you in identifying changes in the system and taking action
promptly. We recommend that, at a minimum, you perform a quality
control test:
• Once a day for all tests being performed in your office that day
• After completing calibration
• When you suspect patient results are inaccurate
• After any major repairs performed on the analyzer
In addition to these, your lab may establish its own requirements. It is
important that the time interval between control tests satisfies both
your needs and the requirements of local regulations.
Operator's Manual
VITROS DT II System
6-1
6.4 How to perform a quality control test
6.4.1 Preparing Lyophilized Controls
Most tests performed on the VITROS DT II System are lyophilized,
(freeze-dried) material, although some are in liquid form. These are
prepared from human and bovine serum and should be handled with
the same precautions that you would with any other serum sample.
The lyophilized controls must be reconstituted before use.
Avoid ingesting any material and wipe up any spills immediately.
Refer to the instruction sheet packaged with the product for storage
and stability requirements.
1. Allow the controls to reach room temperature.
• Materials should be at room temperature before reconstitution.
Vials should sit out approximately 30 minutes if stored in
refrigerator or approximately 60 minutes if stored in the freezer.
2. Open the bottle.
• Remove the metal seal from the bottle. IMPORTANT: DO NOT
allow the control or diluent to stand open without the stopper.
3. Reconstitute the control.
• Tap the top of the bottle to dislodge any particles before opening.
• Invert the diluent bottles several times to mix the contents
thoroughly, but DO NOT SHAKE.
• Use a new pipette tip for each vial.
• Add exactly 3 ml_ of the appropriate diluent to the vial of the
lyophilized control.
• Discard any remaining diluent.
4. Dissolve all lyophilized particles.
• Allow controls to stand for 30 minutes with occasional inversion,
or place on a rotator or rocker for 10 minutes.
• Invert the bottles gently, but do not shake. Check that no
undissolved particles remain before using.
• When not in use, cover the vial tightly, label with the date, and
refrigerate.
• To best realize the keeping stability of the control, transfer the
amount needed for the day's use from the vial into another
container, and return the vial to the refrigerator. Seal the working
container to prevent evaporation.
6-2
Operator's Manual
VITROS DT II System
I
6.5 Analyzing the Controls
1. Run the controls.
• Use the same procedure that you use when analyzing a patient
sample, substituting the control for the patient sample. See
Section 2, "Operating Instructions".
• When the display prompts you to enter the patient I.D., substitute
the lot number on the bottle of the control fluid.
Rev. 2004-03-30
Operator's Manual
VITROS DT II System
6-3
6.6 How to Record the Results
It is important to record the results of your control tests in order to
monitor trends and patterns over a period of time. Data can be
tracked on either of two forms: on a quality control log or on a graph.
6.6.1 Recording Quality Control Results on a Log
If you are using VITROS DT Controls you may find the necessary
information on the yellow assay sheets or you may enter the values
established by your lab.
VITROS CheratSTfysProducts DT Control I Assay Sheet
Lot Number (T1317)
CAT 842 0317
Expiration Dale:
Auquft3i, 1997
VITROS DT Systama
/
1
"
i•
mrnmm V i l u * aa"
Bang*
Qp||» |v»1u.
Rang*
Analytt GEN
AMVL
TBIL
62/63
16B
f>((,'67
129
140
104-154
115=165
\/L
1.1
0.9
' o . e - T6
0.4-1.4
mfl/dtt
mutiny
0.6
BUWJREA
CHOL
CREA
GLU
V
53
54
18
\
15-21
29
40
104-154
115-165
IS
15
10-27
7-24
10
2-19
mfl/dL 1
152-178
148 174
ma/dL
mgrtL
0.6-!.?
mg/dl
74-96
mg/dL
S.4-7.5
AN
"\
•o\
4.7
Units
IM.
U/L
j*mo1/i_
LJTIOL'1
mmDlA.
Ftafaranea Fluid Ganarallon 01
Anaiyta G«n
Value
Ranga
Unlla
CO ?
24.2
19.2-29.2
mmoi/L
cr
80
75-B5
rwr.oi/L
K*
2.9
2.6-3.2
mmol/L
Na +
114 124 mmoK.
119
mmol/1.
53-106SsPmofL
'U . 1-5.3
Control Log
Slwet
317
iot no. changes, use the new comrot aooay
ol Value
12/12
12/13
12/14
12/15
Acceptable?
0.9
1.0
1.8
1.0
find acceplabie ranges and begin e new
Corrective Action/Comments
'Jes
'Jes
9{o
Repeat test-1.4-0.%
Jes
TEC
TEC
TEC
TEC
1. Record the control lot number, test name and range on the log
sheet. Confirm that the control lot number on the assay sheet is the
same as on the bottle of control you are using.
2. Record the date and result on the log sheet.
3. Compare the control value with the assay range on the log sheet.
4. If the control value is within range, it is acceptable. If it is not
acceptable, see the "Quality Control Checklist". Record your
corrective actions as indicated in the example.
5. Write your initials in the space provided.
6. Start a new log sheet when the control lot number changes.
Record the new assay values on the control sheet.
6-4
Operator's Manual
VITROS DT II System
6.6.2 Recording Quality Control Results on a Graph
Charting quality control information on a graph such as the LeveyJennings is a simple way to present data for interpretation because it
provides a visual representation of control results. The chart is based
on the mean and standard deviation values which are calculated
from a minimum of 20 control results for a given laboratory test. The
mean is simply another term for the calculated average and is drawn
as the center on the control chart; standard deviation (SD) is a
statistical method for measuring dispersion. In terms of quality
control, SD is used to evaluate how far quality control results fall
from the mean. The acceptable range for control results is usually
2SD or 3SD. Because results may fall above or below the mean, SD
is expressed as both a positive and a negative value.
A blank Levey-Jennings chart is included in Section 13 of this
manual. We have provided two charts so that you may monitor your
normal and abnormal control results on a single sheet. If you are
using VITROS DT Controls, you may use the mean (value) and range
published on the control assay sheets. Confirm that the control lot
number on the assay sheet is the same as the lot number on the
bottle of control you are using. Using this information, fill in the
Levey-Jennings chart.
VITROS Chemistry Products DT Control I Assay Sheet
LotNumbe<jri317
CAT 842 0317
Expiration D a l e :
Analyte GEN
AugusT3Trre37~"">y
Conventions
Value
Units
Range
VITiflOS DT Systems
SI
\
Value^ Range
Units
AMYL 62/63
61/64/65
129
140
104-154
115-165
U/l
U.t
129
140
TBIl.
1.1
0.9
0.6-1.6
0.4-1.4
mg/dl
mg/dL
19
15
0.6
0.1-1.1
mg/dL
10
2-19
mg/dL
6.4
5.4-7.5
mmoi/L \
mg/dL
mg/dL
4.3
4.2
3.9-4.6
3.8-4.5
m mo I/L
mmo!/f
68
66/67
NBIL
) C^
(""is""1
BUN/UREA
CHOI
Ms
53
S4 (M61
152- 78
148- 74
iWiS4
115-SfE
U/L
U/L
10-27 \ m t o l / L
7-24 (tfhoM.
(imolO
D T E M o d u l e s ••
Reference Fluid Generation 01
Analyte Gen
Value
Range
Units
CO,
24.2
19.2-29.2 mmol/L
cr
80
75-85 mmol/L
K*
SNa
+
2.9
2.6-3.2 mmol/L
119
114-124 mmol/L
Obtain from the side panel
of your box of slides.
Limit
Observed
Value
r
Operator's Manual
VITROS DT II System
6-5
1. Write the test name, generation number, slide lot number, control
and control lot number in the spaces indicated above the
appropriate chart.
2. Fill in the mean (value), +2SD and -2SD values from the assay
sheet. To determine the SDs from the published assay sheet:
+2SD = the upper range value listed on the assay sheet.
-2SD = The lower range value listed on the assay sheet.
3. Fill in the +1SD and -1SD values, which must be calculated
accordingly.
+1SD = mean value + (+2SD value)
2
-1 SD = mean value + (-2SD value)
2
4. You are now ready to record results. Be sure to record the date and
control test with each entry.
6.7 Interpreting Control Results
6.7.1 Interpreting the Control Results from the Log
If you are using VITROS DT Controls compare the printout with the
results listed on the assay sheet that is packaged with the controls.
Or you can compare the printout with the values established by
your lab.
If results are within range, it is acceptable.
If results are outside the range, repeat the procedure for that
particular test and consult the checklist at the end of this chapter.
6.7.2 Interpreting the Control Results from the Graph
Generally, a test is considered "in control" if the results fall within
the ±2SD range on the chart. If the control result falls outside the
2SD limit, there may be a problem that requires attention. Results
may also fall out of range clue to random chance. In either case,
simply repeat the test. If the control result falls back in range, the test
is considered in control and you may proceed to report patient
results.
Other conditions that the chart will reveal to you are trends and
shifts. A trend in a control chart refers to a series of control values
that continue to increase or decrease over a period of several
consecutive days. It may be indicative of an unsatisfactory laboratory
condition. When values on several consecutive days fall on one side
of the mean but remain at a constant level, the trend is referred to as
a shift.
Regular use of the Levey-Jennings chart will not only assist you in
documenting your quality control activities, but can provide insight
into the overall performance of each test for preventive actions
before control values go out of range.
6-6
Operator's Manual
VITROS DT II System
This control chart indicates
a trend in the observed
value from 2/7 to 2/14,
respectively.
'SUihi____ Gen # J 0 _
Slide Lots
0153-0223-4789
Control Vitro?'PI'ControlJ Control Lot #
'11317
Level 1
Date
Upper =
Limit
—-----
91
Mean =
Lower _
Limit
Observed
Value
Corn ictive Action:
2/14/96
Level1:
Reviewed: Date __2/2&/96
This control chart indicates a
shift in the observed value
from 3/11 to 3/14,
respectively.
Cleanedpipette/repeatedtest
Signature
Test
'3itJ{
Gen# S3
Slidel_ot#
0_l53-0223-41S9
__J&£ity_!D_ay_
control Vitms•DIComroll_ controlLots
_.
T1317_
Level 1
Date
Upper =
Limit
21
Mean = _
Lower
=
Limit
15
corrective Action:
3/15/96
Reviewed- Date
3/28/96
Level1: '-Reconstituted a new vial of control
Signature
'Betty 'Day
6.8 Establishing Your Own Control Ranges
The determination of the target value for your laboratory is based on
statistical methods. Whenever you test a quality control fluid
containing a known quantity of a certain analyte, your test results
will vary slightly due to such factors as: environmental differences,
how the test was performed, and the performance of the analyzer.
These variations are considered normal.
However, it is important in assuring test accuracy that your results
fall within the established range of the control, preferably close to
the target value.
Operator's Manual
VITROS DT II System
6-7
6.8.1 How to Calculate the Mean
A mean (average) can be calculated on a calculator. The following is
an example of how to calculate a mean for the last 10 quality control
tests you have run, for example, on glucose: (For statistical analysis
you may want to collect more data points.)
llOmg/dL
120mg/dL
lOOmg/dL
107 mg/dL
112mg/dL
120 mg/dL
103 mg/dL
110 mg/dL
104 mg/dL
114 mg/dL
1. To calculate the mean, add these values. The total is 1100.
2. Divide this number by the number of values quality control tests
you obtained, in this case 10. Thus, your mean for glucose is
110 mg/dL (1100 + 10 = 110).
Operator's Manual
VITROS DT II System
6.8.2 Variables to Consider in Establishing the Mean
The values used to calculate the mean will affect the result. Although
many commercially available control fluids have been tested to
provide a pre-determined mean, you should establish your own
mean target for each test.
To establish such a mean, you should run quality control tests daily
for a number of days. In hospital laboratories, at least 20 days of
quality control results are gathered. Running QC tests for 20 days
before establishing a mean target value for each test may not be
feasible for an in-office laboratory, therefore you should obtain a
mean that includes at least five to ten days of QC results.
The mean that you establish for your laboratory should take into
account a number of important variables so that it simulates the
situations that occur during normal patient testing as closely as
possible.
For instance, day-to-day variables are critical. The results used to
calculate the mean must have been gathered over several days to
account for day-to-day changes in the environment and in
instrument upkeep.
If more than one person operates the analyzer, you must also
account for operator-to-operator variables in establishing your mean.
In other words, all the operators who run patient tests must have a
portion of the QC test that you use in deriving the mean.
Your mean should also include vial-to-vial variables. The QC results
used to calculate the mean must be run using more than one vial of
control fluid.
6.8.3 Calculating the Standard Deviation
Standard deviation is a statistical method for measuring dispersion.
In terms of quality control, standard deviation is used to measure
how far quality control results differ from the average that you
established. You should establish a standard deviation for each test
when you have established your mean. This standard deviation
measurement can make use of the same values used in deriving the
mean.
Operator's Manual
VITROS DT II System
6-9
6.8.4 How to Calculate a Standard Deviation
1. Calculate your mean as shown in section 6.8.1. In this case the
mean was 110.
2. Calculate how much each of your values deviates, or differs from
the mean.
110 mg/dL = mean, so deviation = 0
120mg/dL = mean+10
100 mg/dL = mean -10
107 mg/dL = mean -3
112 mg/dL = mean +2
120 mg/dL = mean+10
103 mg/dL = mean -7
110 mg/dL = mean, so deviation = 0
104 mg/dL = mean -6
114 mg/dL = mean +4
3. Then you square each of these deviations, which means that you
multiply it by itself.
o 22 = 0
10 = 100
-10 2 = 100
-32 = 9
22 =
4
102 = 100
- 7 2 = 49
02 = 0
- 6 2 = 36
4 2 = 16
4. Add all of the squared values together.
0
100
100
9
4
100
49
0
36
16
414
6-10
Operator's Manual
VITROS DT II System
5. Next, divide this sum by the total number of values minus one, in
this case, 1 0 - 1 . You would divide by nine in this example.
(414-9 = 46).
6. Finally, you take a square root of this value. This step is designed
to "undo" the extra step that you took earlier in which you squared
all the values. You can easily find the square root by using a
pocket calculator.
This square root of 46, which is written 46 equals 6.78 (approx.). In
this example, 6.78 - one standard deviation.
Generally, a test value is considered to be acceptable from a quality
control point of view, if it is within two standard deviations of the
mean that you have established. In the example given, then any
quality control result for glucose that was within 6.78 x 2 or 13.56
mg/dL, of the mean of 110 would be considered acceptable. This
would include any values between 96.44 (110- 13.56 = 96.44) and
123.56 (110+ 13.56 = 123.56).
NOTE: The standard deviation you obtain should be similar in
magnitude to those published by the manufacturer. A result that is
much higher than stated by the manufacturer's figure can signal a
system problem.
Operator's Manual
VITROS DT II System
6-11
6.9 Quality Control Troubleshooting Chart
If a quality control value is inaccurate follow these guidelines to
correct the problem.
Factors to Consider
Slides
Control
• Stored properly.
• How old is the
control?
If > 7 days, use a
new one. Check
assay sheet for
stability.
• Warmed
sufficiently.
• Lot calibrated.
• Were
reconsitution
procedures
properly
followed?
Pipette
Reference Fluid
• Tip(s) inserted
properly.
• DTE II Module
only.
• Tip fill sufficient.
• Pipette removed
at correct time
after spotting.
• Stored according
to requirements;
usable for only
30 days after
opening.
• Check battery—
was battery low
indicator on?
• Fluid warmed
sufficiently.
• For DTE II
Module—leave
• Stored according
to requirements.
button
depressed after
• Warmed
V V CA 1 1 1 I
vj
spotting until
sufficiently.
you remove from
locator.
V-^
Step
1. Rerun the
control.
• Check expiration
date on carton.
• How long at
room
temperature in
dual-sample
cup?
• New VITROS
Reference Fluid
lot # requires
calibration of
Na + , K*, Cl", and
co2.
2. If QC fails
again, call your
Customer
Support Center.
6-12
Operator's Manual
VITROS DT II System
6.10 Factors to Consider When Your Results Are Out of Range
You may find that your quality control results occasionally fall
outside the acceptable range you have established, even after you
repeat the QC test; or you may become suspicious of the results you
obtain when you run patient samples. Either condition should alert
you to the need to check the factors:
• Instrument maintenance
• Housekeeping procedures
• Errors in labeling and transcription
• Centrifugation
• Pipetting technique
• Pipette performance
• Storage and handling of patient samples
• Storage and handling of test fluids and supplies
• Calibration
• Storage and handling of patient samples
- Keep all samples tightly capped.
- Frozen samples should be properly mixed when thawed.
- Spin down samples before you store them and draw serum/
plasma off.
- Store samples in the refrigerator (refer to Instructions for Use).
- Warm refrigerated samples to room temperature before
analyzing them.
Rev. 2003-10-01
Operator's Manual
VITROS DT II System
6-13
6-14
Operator's Manual
VITROS DT II System
Options
Keyboard options are primarily used to check the function of the
equipment after it is initially installed. They are also used in
troubleshooting the equipment. For example, you may run a certain
option to respond to an error message on the display. Some options
are also used to obtain data that are stored in th.e microcomputer's
memory - for instance, the type of reporting units for a test.
7.1 How to Run Options
To access the options you must be in the service mode of operations.
Follow the sequence outlined below to enter the service mode from
the run mode, and then to return to the run mode when you have
completed running the desired options.
To enter the service mode:
• Press SHIFT then SERVICE/CAL MODE.
• When the display prompts you to ENTER OPTION NO., key in the
desired option number and press ENTER.
• To exit the service mode, press SHIFT then SERVICE/CAL MODE.
NOTE: You cannot enter the service mode when the DT60 II system
is processing samples. Wait until all samples are processed before
executing options.
7.2 Options for the VITROS DT60 II Chemistry System
OPTION NUMBER
DESCRIPTION
0
TERMINATING OPTIONS
Terminates Options 1, 2, 6, 7,
8, 14, and 31.
1
SLIDE TO INCUBATOR
Activates the mechanism
(upper rack) that transports a
slide from the spotting station
to the incubator. Use Option 0
to terminate.
POSITION WHITE REF AT
READ
Advances the lower slide
transfer mechanism (lower
rack) to the correct position for
a white reference reading. Use
Option 0 to terminate.
Operator's Manual
VITROS DT II System
7-1
OPTION NUMBER
7-2
DESCRIPTION
3
ENTER # OF CYCLES (199)
Cycles the slide transfer
mechanism. This option is selfterminating. To specify number
of cycles:
• Key in the desired number of
cycles.
• Press ENTER.
4
PRINTER TEST IN
PROGRESS
Checks the operation of the
printer by printing out the
entire set of characters from A
to Z and 0 to 9, and all
punctuation marks. This option
is self-terminating.
5
(Display lights up)
The two rows of 40 black
rectangles light up.
6
GREEN LED TEST
Lights the green LED in the
FORS head. Run Options 0, 7,
or 8 to terminate.
7
RED LED TEST
Lights the red LED in the FORS
head. Run Options 0, 6, or 8 to
terminate.
8
YELLOW LED TEST
Lights the yellow LED in the
FORS head. Run Options 0, 6,
dr 7 to terminate.
9
RAM CHECK-INITIALIZE
O N D14
Tests the read-write memory
O N D14(RAM) in the analyzer.
This option reinitializes the
analyzer. Rerun all tests for all
slides that were in the analyzer
at the time of the loss. This
option is self-terminating.
Operator's Manual
VITROS DT II System
OPTION NUMBER
Rev. 2003-10-01
DESCRIPTION
10
PROM MEMORY CHECK
(IS VALID or ERROR IN
PROM or D13)
Tests the read-only memory
(PROM). If the display reads:
• ERROR IN P R O M - t h e
keyboard will not accept any
further information until the
problem is resolved.
• PROM OK - the option will
be self-terminating at its
completion.
• D13-PROM CHECKSUM
ERROR - call your Customer
Support Center.
11
U.S. UNITS IN EFFECT or
S.I. UNITS IN EFFECT
Displays current reporting
units.
Run Option 63 to select U.S.
Units or Option 64 to select
Standard International Units
(S.I.)- This option is selfterminating.
12
LAST 64 KEYSTROKES
Prints out the last 64 characters,
entered. This option is selfterminating.
13
VERSION XX.X CDM
XXXX ALL RIGHTS
RESERVED
1995
COPYRIGHT OCD
Displays the current version of
software and the CDM number
installed in your system.
14
A/D READS TO PRINTER
This test is usually performed
only at the request of service
personnel. Prints the analog-todigital reading with each test
result in the run, calibration or
service mode. Run option 0 to
terminate.
Operator's Manual
VITROS DT II System
7-3
OPTION NUMBER
7-4
DESCRIPTION
16
LED#? (GR =6, RD =7,
YL =8, OFF =9)
Prints analog-to-digital reading
of the light coming through
FORS. The display will prompt
you to enter the followfng data:
• ENTER STEP CNT - select the
number of steps to move the
lower rack assembly (-255 to
+255).
• ENTER # OF READS - select
the number of analog-todigital readings.
• Your selections will appear
on the display as they are
made.
17
ENTER DATE NN-NN-NN
Date should be entered before
routine analyses begin. Use the
numeric keys to enter any 8
digits. The dashes must be
entered between the numbers
or the date will not be
recognized. Press the ENTER
key after you have entered all
numerals and dashes. Do not
press ENTER after each
individual entry. The date will
then be printed out with every
patient ID for your recording of
records. See Section 2.2 for
when you should enter the
date.
18
ENABLE COUNTDOWN
When enabled, shows the
amount of time left for slides in
the incubator. Energize the
analyzer again to delete this
option.
22
REPORT NH 3 WITH
CREATININE
Prints out an ammonia result
with a creatinine result, if
DSCREA is run.
23
CRC PROCESSING
ON/OFF
Turns the capability to process
Coronary Risk Classification on
and off. Allows you to verify
the status as on or off.
Touch 1 to turn on and 0 to
turn off.
Operator's Manual
VITROS DT II System
OPTION NUMBER
DESCRIPTION
24
CRC DATA INPUT
EDITING
This option automatically turns
CRC on and allows you to
input the data necessary to run
Coronary Risk Classification
and to run "what if..." tests. See
Section 3, "Coronary Risk
Classification" for specific
operating instructions.
25
GLOB AND A/G RATIO
ON/OFF
Globulin and
Albumin/Globulin ratio
calculations on and off. Allows
you to verify the status as on or
off.
turn off. Option 25 will remain
on even if the analyzer is
powered off and then on again,
until the option is manually
turned off.
26
LIPIDCALC.-VLDL, LDL
AND CHOL/HDLC
RATIO ON/OFF
VLDL, LDL and CHOL/HDLC
ratio calculations on and off.
Allows you to verify the status
as on or off.
27
AGP ON/OFF
Turns the capability to
processAnion Gap (AGP)
calculations on and off. Allows
you to verify the status as on or
off.
turn off. Option 27 will remain
on even if the analyzer is
powered off and then on again,
until the option is manually
turned off.
Operator's Manual
VITROS DT II System
7-5
7-6
OPTION NUMBER
DESCRIPTION
30
SAV UPDATE SELECT
TEST AND INDEX
Allows you to change the SAVs
and the post-prediction values
for any test.
For SAVs:
• When the display prompts
you with SELECT
CHEMISTRY, press the
CHEMISTRY SELECT key to
advance to the desired test.
• Press 1, 2, 3, or 4 to access
the values for bottles 1, 2, 3,
or 4.
• To change values, press the
CLEAR key and enter the new
value.
• To cancel, press
SERVICE/CAL MODE.
For post-prediction values:
• Press 6 to display the postprediction slope.
• Press 7 to display the postprediction intercept.
• To change the values, press
the CLEAR key and enter the
new value.
• To cancel, press
SERVICE/CAL MODE.
31
CDM DATA NOT USED:
UNIT WILL USE EA
PROM CAL VALUES
Use this option after using
option 30 to change SAVs and
before calibrating. Use Option
0 to terminate once calibration
is complete.
32
CALIBRATION UPDATE
SELECT CHEMISTRY AND
INDEX
Allows you to enter and print
calibration parameters.
• Press the CHEMISTRY
SELECT key to scroll to the
desired test.
• Press 1, 2, 3, and 4 for
calibration parameters.
• Press 5 for the web
generation number.
• To update the value, press the
CLEAR key then enter the
new value, and press ENTER.
• To print values, press the
PRINT key.
• Press SERVICE/CAL MODE to
terminate the option.
Operator's Manual
VITROS DT II System
OPTION NUMBER
DESCRIPTION
33
SEL-F1ELD, ENT-VALUE,
PRINTSO WB BF (Access
spline values off the CDM)
This option should be used
only when recommended by
trained OCD service
personnel.
• This option is used in
conjunction with Option 35
to print a selected group of
spline records from the
CDM. For the spline records,
SO number, web generation,
and body fluid code are used
in the record system.
• Run Option 35 first.
SELECT key to move from
one field to another.
• Select the field and use 0-9
for A-J, and SHIFT 0- SHIFT 9
for K-T. The CLEAR key clears
any previous values.
• Press PRINT to obtain all t
spline records.
34
SEL-FIELD, ENT-VALUE
PRINTSO WB BF KN
(Access SAV calibrator
values off the CDM)
This option should be used
only when recommended by
trained service personnel.
• Run Option 35 first.
SELECT key to move from
one field to another.
• Select the field and use 0-9
for A-J, and SHIFT 0-SHIFT
9 for K-T. The CLEAR key
clears any previous values.
• Press PRINT to obtain all
SAV values.
35
CDM LISTING O=FULL
1=SHORT
The default for the Options 33
and 34 is the short form. Press
0 to obtain a long form.
36
PRINTING REFERENCE
FACTORS (for DT60 II)
Prints the correction factors
and reference slide
reflectances.
NOTE: Use Option 50 to obtain
the data for the DTSC II Module.
Rev. 2003-10-01
Operator's Manual
VITROS DT II System
7-7
7.2.1 Serial Communication Options for the DT60 II System
7-£
OPTION NUMBER
DESCRIPTION
19
SERIAL
COMMUNICATIONS
TEST
This option is used to check the
data transfer from the DT60 II
System to an attached
computer system.
• TEST OK - A record was
successfully sent out and an
acknowledgment was
received by the external PC.
• UNABLE TO TRANSMIT The test record was not
transmitted.
• NO RESPONSE FROM PC
No acknowledgment was
received from the PC.
20
DATA INTERFACE
LOOPBACK TEST
This option runs an interface
test.
• Plug an interface connector
onto the end of the serial
communications cable.
• TEST OK - All characters sent
and received correctly.
• TEST FAILS - The characters
are not sent or received
correctly.
21
INTERNAL LOOPBACK
TEST
This option runs an internal
loopback test.
• TEST OK - All characters are
sent and received correctly.
• TEST FAILS - The characters
are not sent or received
correctly.
Operator's Manual
VITROS DT II System
7.3 Options for the VITROS DTE II Module
OPTION NUMBER
DESCRIPTION
40
DTE ELECTROMETER
FORWARD or
ELECTROMETER AT READ
Advances the electrometer to
the read position. Run Option
41 to terminate the option.
41
DTE ELECTROMETER
REVERSE or
ELECTROMETER AT
HOME
Returns the electrometer to the
home position. This option is
self-terminating.
42
ENTER # OF CYCLES
Cycles the drive mechanism a
specified number of times. Key
in the desired number of cycles
and press ENTER. This option is
self-terminating
43
DTE ELECTOMETER
VERIFIED
Verifies the electrical
performance of the
electrometer. The gain factor,
reference, and offset values of
the electrometer will be the
following range:
GAIN FACTOR 24.0 to-21.5
REFERENCE 80.22 to-83.46
OFFSET
0±1
This option is self-terminating.
44
DTE MODULE TEMP TEST
STARTED
Checks the incubator in the
module. This test takes 40
seconds from the time you
select the option. The following
display messages may appear:
•DTE MODULE TEMP OK
- temperature is within the
correct range.
• DTE MODULE TEST FAILED
- temperature is outside the
proper range.
Operator's Manual
VITROS DT II System
7-9
7.4 Options for the VITROS DTSC II Module
OPTION NUMBER
7-10
DESCRIPTION
50
DTSC REFERENCE
VALUES (prints correction
factors for DTSC II)
The black and white correction
values and reference slide
values are printed out. Values
are printed only for the filters
that are in use. Each value will
be labeled with its
corresponding wavelength.
52
DTSC TEMPERATURE
Prints out the temperature in
degrees Celsius.
53
DTSC SOFTWARE
VERSION XX.X
Prints out the current software
version number.
Operator's Manual
VITROS DT II System
Troubleshooting
The software of the VITROS DT60 II Chemistry System,
VITROS DTE II Module, and VITROS DTSC II Module monitors
many hardware functions. Information regarding most sources of
malfunction is provided to you through the display or the paper
printout. This section provides you with instructions on what to do
when your analyzer is not operating properly, including suggestions
on the possible causes.
8.1 General Troubleshooting
Each description in this section lists one or more possible causes and
a series of operator responses. Perform the steps in the order
indicated. If one step does not correct the problem, proceed to the
next one, and so forth, until all suggested responses have been
completed. If the analyzer is not properly operating after all the
suggested responses have been completed, contact your Customer
Support Center.
POSSIBLE CAUSE
VITROS DT60 II System
cannot be turned on.
VITROS DTE II Module is not
operating.
OPERATOR RESPONSE
• Power cord pulled from
the analyzer or from the
outlet.
• Verify that the power cord is
plugged securely into the power
outlet and the analyzer.
• Main power switch in
the OFF position.
• Verify that the main power switch
at the back of the analyzer is in the
ON position.
• Nonfunctioning outlet.
• Verify that the outlet is functioning.
• If the analyzer is still not
functioning, call your Customer
Support Center.
• Cable leading from
module to the analyzer is
not securely fastened.
• Instrument malfunction.
• Check that the cable leading from
the analyzer to the DTE II Module
is securely plugged in. Turn the
analyzer off, then on again. If the
problem recurs, call your
Customer Support Center.
Operator's Manual
VITROS DT II System
8-1
POSSIBLE CAUSE
OPERATOR RESPONSE
• Cable leading from
module to the analyzer is
not securely fastened.
• Check that the cable leading from
the analyzer to the DTSC II
Module is securely plugged in.
Turn the analyzer off, then on
again. If the problem recurs, call
your Customer Support Center.
• Power cord is not
securely plugged into the
outlet.
• Check that the plug is plugged
securely into the outlet.
• Main power switch is.
OFF.
• Turn the switch to the ON position.
• Nonfunctioning outlet.
• Verify that the outlet is functioning.
Printer working but does not
print hard copy.
• Printer paper inserted
with heat sensitive side
on the back. The heat
sensitive side of the
paper marks when
scratched with finger
nail.
• See Section 5.6.2, "Paper
Loading," for correct loading
procedures.
Complete power loss.
• Main power switch in
OFF position.
• If the main power switch is in the
OFF position, turn it to the ON
position.
• Power cord pulled from
the power outlet.
• Verify that the power cord is
plugged securely into the analyzer
and into the power outlet.
• Turn the main power switch to the
OFF then ON again.
• Rerun tests for all slides that were
in the analyzer at the time of the
power loss.
• Repeat the calibration process for
all tests being calibrated at the
time of the power loss.
• If the problem recurs, call your
VITROS DTSC II Module is not
operating.
3-2
Operator's Manual
VITROS DT II System
POSSIBLE CAUSE
Temporary power loss.
• Line voltage dropped
below specifications.
OPERATOR RESPONSE
If the voltage temporarily drops
and then returns to normal, the
unit will reinitialize. After
reinitialization, repeat tests for all
the slides in the analyzer at the
Repeat the calibration process for
all tests being calibrated at the
8.2 Pipette Troubleshooting
Please refer to the VITROS DT Pipette User's Guide for information
on cleaning and charging the DT Pipette.
|
8.3 Unexpected Results (Analyzer Tracking Errors)
Tracking errors occur when the sequence of slides in the DT60 II
System does not match the sequence the analyzer was expecting.
Tracking errors are caused when display prompts are not followed
exactly or when the slide disposal box is overfilled. Tracking errors
cause the analyzer to report unexpected results such as:
• A series of results outside the analyzer range when running
multiple chemistries on the DT60 II System.
• A series of highly unusual results outside the expected
physiological range.
• Occasional slide transport malfunctions that are reported as F12 F15 error codes - "Transfer malfunction."
• Calibration failures that are reported as C13 (EXTREMA) or C18
(MONOTONICITY) error codes.
Possible Causes
• A slide is pushed into the analyzer prematurely when the display
shows a WAIT prompt. This may cause a transfer malfunction.
• A slide is not removed from the analyzer when the display prompts
to do so. An example is an unreadable bar code on a slide that
causes the analyzer to reject the slide.
Rev. 2004-03-30
Operator's Manual
VITROS DT II System
8-3
• An incorrect usage of the delete test key. The delete test key deletes
a test after a slide has been entered, identified, and spotted. When
a test is deleted, the slide must continue through the analyzer. Do
not remove a slide manually once it has been deleted.
IMPORTANT: If a slide is removed manually after the delete test is
requested, a tracking error will occur.
• A slide disposal box that is not emptied on a daily basis. An
overfilled slide disposal box causes the slides to backup resulting
in a tracking error.
If You Suspect a Tracking Error
1. Wait until the analyzer has finished processing.
2. Empty the slide disposal box.
3. Enter the service mode by pressing SHIFT then SERVICE/CAL
MODE.
4. When the display prompts you to ENTER OPTION NO., press 3
then press ENTER.
5. When the display prompts you to ENTER # OF CYCLES (1-99),
press 6 then press ENTER.
6. After the cycles have completed, check the slide disposal box.
IMPORTANT: If the slide disposal box does not contain exactly one
slide then a tracking error has occurred.
7. Exit the service mode by pressing SHIFT then SERVICE/CAL
MODE.
8. The analyzer is now ready to resume routine operation.The above
actions have cleared the tracking error. Please review and confirm
previous results.
Important Points to Remember
• Please follow the display messages.
• Insert and remove slides only when the display indicates to do so.
• Once the slide is spotted, use the SHIFT + DELETE keys to inhibit
results from printing, but do not remove the slide.
8-4
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
Instrument Status Messages
Status messages may appear on the display of the printout during the
course of normal operation — for instance, in response to
information that you input or in response to actions such as inserting
a slide. This section includes a list of all messages along with
explanations of the messages and recommended responses to them.
9.1 Status Messages
The messages in this section, for the most part, do not point to
equipment malfunction. Instead they are designed to "talk you
through" various operating procedures.
MESSAGE
EXPLANATION
ANALYZER INITIALIZATION
(Display)
The DT II System is going
through a series of selfchecks.
ANALYZER READY-CREA/NH3
ONLY (Display)
An N H 3 slide is in the
incubator.
ACTION TO TAKE
• Wait until the message
disappears before attempting
to run any tests.
You must run a creatinine or
ammonia slide next. To run
any other tests wait until the
creatinine and ammonia
slides clear the incubator.
• In the CAL mode, creatinine
and ammonia cannot be run
while a slide for BUN is in the
incubator.
Run a slide other than a
creatinine or ammonia slide.
ANALYZER TEMP. LOW
(Display)
Instrument is still warming
up.
If the message appears when
the analyzer is first turned on,
wait until ANALYZER READY
message is displayed
(approximately 25 minutes).
COVER OPEN (Display)
• Pipette locator cover on the
analyzer was left open longer
than 5 seconds.
Check to see that the pipette
locator cover is closed
properly. After it is closed, the
INCUBATOR WARMING UP
message will appear. Wait
until the display disappears
and the ANALYZER READY
display appears before
running the next test.
ANALYZER READY — NO
CREA/NH 3
COVER OPEN TEST
INVALIDATED (Printout)
Operator's Manual
VITROS DT II System
9-1
MESSAGE
DISCARD PM SLIDE AND
REPEAT (Display)
EXPLANATION
Bar code reader cannot read
the bar code on slide.
Slide inserted upside down.
The patient sample and
electrolyte reference fluid
were dispensed without first
loading a slide.
ACTION TO TAKE
• Discard slide and repeat the
test. This message will be
displayed until the cover is
lifted.
• Clean the barcode reader.
• Remove pipette locator cover.
Examine internal assemblies
and clean any serum or
electrolyte reference fluid that
may be present, following the
instructions in Section 5.3.
DTE ELECTROMETER
CYCLING (Display)
A DTE II Module option was
requested, and the
electrometer is still cycling.
ENTER CALIBRATOR KIT
NUMBER (Display)
The analyzer is prompting
you to enter the number of
the calibrator kit. This
message appears after you
enter the calibration mode.
Using the numeric keys on
the keyboard, enter the
number of the calibrator kit
that you are using. This
number is found on the box
of calibrator fluids.
ENTER CALIBRATOR BOTTLE
(Display)
you to enter the bottle
number of the calibrator.
the keyboard, enter the level
(1, 2, 3, or 4) of calibrator that
you are about to use.
ENTER REF FLUID GEN NO.
(Display)
you to enter the reference
fluid generation number on
the bottle of VITROS DT
Reference Fluid.
Enter the generation number.
If you do not have the DTE II
Module, enter the number 1.
ENTER SLIDE GENERATION
(Display)
you to enter the generation
number of the slide. This
message appears after a test is
selected in response to the
SELECT TEST message.
the keyboard, enter the
generation number of the
slide that you just inserted.
The generation number can
be found on the box of slides
being used. (The ENTER key
must be pushed twice to
identify the generation on the
DTSC II Module).
9-2
Operator's Manual
VITROS DT II System
• Wait until you hear the
electrometer stop cycling,
then run the desired option.
MESSAGE
EXIT SERVICE MODE FIRST
(Display)
EXPLANATION
ACTION TO TAKE
• You tried to run a test while
the instrument is in the
service mode.
• Exit the service mode by
pressing the SHIFT and
SERVICE keys on the
keyboard.
GAIN CHANGES
This message is for service
use only.
No operator response.
INCUBATOR FULL (Display)
Incubator is filled to capacity.
Wait until message
disappears or until the
analyzer processes at least
one test result before entering
another slide.
If you had already entered a
slide, lift the pipette locator
cover and remove the slide to
prevent a jam. Close the
cover within 5 seconds or the
analyzer will reinitialize.
INCUBATOR WARMING UP
(Display)
INSERT NH3 SLIDE (Display)
OPEN COVER TO CLEAR
(Printout)
The incubator in the analyzer
has not yet warmed to the
proper operating temperature.
• This message is displayed
after spotting a creatinine
slide to indicate that the next
slide to be run must be an
N H 3 slide.
Printed as a result of a slide
jam. The message that follows
on the printout (F11-F15
TRANSFER MALFUNCTION)
indicates the location of the
jam.
Operator's Manual
VITROS DT II System
Wait until the ANALYZER
READY message appears
before you attempt to run any
tests.
Load a slide for
• Open the pipette locator
cover and remove the
jammed slide.
• When you close the cover,
the instrument will
reinitialize. Wait for the
ANALYZER READY message
to appear before running
another test.
9-3
MESSAGE
REMOVE CM SLIDE (Display
and Printout)
EXPLANATION
You tried to spot a slide that
was not identified.
Bar code reader cannot read
bar code on slide.
You dispensed the patient
sample without first loading a
slide.
ACTION TO TAKE
• Check to be sure the slide is
inserted into the correct
module.
• Open pipette cover and
remove slide within 5
seconds by pulling it back
from the ends. (Do not touch
center of slide because i t .
contains the reagent).
NOTE: If the pipette cover is
open longer than 5 seconds, the
analyzer will delete all slides in
the incubator and require an
incubator warm up. If a slide is
being read at the same time that
the cover is open, that slide result
may be deleted.
• Reinsert the slide at a faster
rate of speed. If the bar code
reads, continue processing. If
the bar code does not read,
open the pipette locator and
clean the bar code sensor
with a dry swab. After the
analyzer displays READY,
reinsert the slide. If the bar
code reads, continue
processing slides. If the bar
code still does not read, call
your Customer Support
Center.
9-4
Operator's Manual
VITROS DT II System
MESSAGE
RESULTS ABOVE ANALYZER
RANGE (Printout)
EXPLANATION
• In the calibration mode, this
message informs you that the
result from the calibrator fluid
is above the range of the
analyzer.
• Incorrect information was
manually entered.
• In the run mode, the sample
concentration is above the
analyzer range.
ACTION TO TAKE
• Rerun the calibrator fluid in
question.
• If message recurs, reconstitute
a fresh calibrator fluid and
rerun the test. If message
recurs, call your Customer
Support Center.
• If the CHEMISTRY SELECT
key was used, make sure that
all the information entered
was correct.
• Dilute the sample and rerun
the test. (Be sure to adjust the
results according to the
dilution factor). See the
Instructions for Use for the
test you are running for more
information on dilution
procedures.
• If message recurs, call your
RESULTS BELOW ANALYZER
RANGE (Printout)
• In the calibration mode, this
message informs you that the
result from the calibrator fluid
is below the range of the
analyzer.
• In the run mode, the sample
concentration is below the
analyzer range.
"• Rerun the calibrator fluid in
question.
• If message recurs, reconstitute
a fresh calibrator fluid and
rerun the test.
• If the CHEMISTRY SELECT
key was used, make sure that
all the information entered
was correct.
• Rerun the test.
• If message recurs, run a
quality control test. If quality
control results are within the
proper range, report the test
results as being below the
analyzer range.
Rev. 2003-10-01
Operator's Manual
VITROS DT II System
9-5
MESSAGE
SELECTING DTSC TEST
(Display)
SLIDE NOT IDENTIFIED
(DT60 II System) (Display)
EXPLANATION
This message is asking you to
verify your test selection.
• Slide was inserted backward.
• Instrument was unable to
read the bar code.
• Unsteady motion while
inserting the slide.
ACTION TO TAKE
• Press ENTER to verify the
selection. If the selection is
incorrect, use the
scroll to the correct test and
then press ENTER.
• Do not remove the
unidentified slide. Leave it in
the instrument and use the
manually select the test that
you have loaded into the
spotting station.
• If the analyzer prompts you to
remove the slide, do so as
quickly as possible. If the
cover is open more than 5
seconds, it could result in the
loss of the tests in progress.
• If any of these problems recur,
call your Customer Support
Center.
9-6
Operator's Manual
VITROS DT II System
MESSAGE
SLIDE NOT IDENTIFIED
(DTE II Module) (Display)
EXPLANATION
ACTION TO TAKE
Slide was inserted backward.
• Visually check to see that the
slide is correctly positioned
below the pipette locator at
the spotting station. The slide
should be positioned as
indicated in the diagram on
the slide track. (The two small
holes where the sample and
reference fluid are deposited
should face you.)
Instrument was unable to
read the bar code.
Instrument malfunction.
• If the slide is positioned
correctly, press the
manually identify the test.
• If the slide was inserted
backward, insert a new slide.
You can do this even while
the SLIDE NOT IDENTIFIED
message appears on the
display.
• If the message remains, call
your Customer Support
Center.
TEST DELETED (Display and
Printout)
The test was deleted by the
operator before it was
complete.
Leave slide in and repeat test.
TESTS INVALIDATED
(Printout)
The pipette locator cover was
left open longer than 5
seconds, so the incubator
temperature dropped and the
tests in progress were
invalidated.
Check to see that the cover is
closed. Wait for the
ANALYZER READY message
to appear, then repeat the test
in question.
Operator's Manual
VITROS DT II System
9-7
MESSAGE
EXPLANATION
ACTION TO TAKE
TEST MISSING BOTTLES
LOAD XXX OR PRESS CAL TO
EXIT (DT60 II System)
(Printout and Display)
• This message appears when
exiting the calibration mode.
The analyzer is indicating that
you accidentally forgot to run
a bottle during the calibration
procedure, or you had an
invalid calibration reading.
Load a slide for the test
indicated to find out which
calibrator bottle you are
missing. Any number that is
not flashing indicates the
bottle that you need to run.
After running the missing
bottle(s) and after valid
replicate numbers are
printed, press the CAL key to
exit the calibration mode.
WAIT—SLIDE BEING LOADED
(Display)
• The analyzer is indicating that
the slide you just spotted with
fluid on the DT60 II has not
yet been transferred into the
incubator.
Wait until this message is
replaced by the ANALYZER
READY message before trying
to insert the next slide.
IMPORTANT: DO NOT insert
slide until the DT60 indicates
"Analyzer Ready".
XXX (test name) USES
BOTTLES (1,2,3,4) ENTER
BOTTLE NO. (Printout and
Display)
9-8
During the calibration
procedure, after the bar code
on the slide is read, the
analyzer is prompting you to
choose the calibrator bottle
that you want to run.
Operator's Manual
VITROS DT II System
To respond, enter the bottle
number (press 1 , 2 , 3 , 4) to
indicate which calibrator
bottle you have chosen to
run.
Rev. 2004-03-30
In addition to monitoring operating procedures, the analyzer's
microcomputer monitors several analyzer functions and alerts you
by means of coded warning messages on the display panel and/or
the paper printout if there is a deviation from performance
specifications. This section lists these coded messages in
alphabetical and numerical order.
10.1 Coded Warning Messages
The code number beside each message appears on the printout and/
or the display along with the message. It is designed to help you
locate troubleshooting information in this manual. The code number
also provides valuable information to your Customer Support Center
in case the instrument fails to operate properly after you have tried
all the suggested responses listed here. If the problem persists, call
your Customer Support Center.
10.1.1 Calibration (C)
CODE/MESSAGE
EXPLANATION/CAUSE
C12
INVALID
CALIBRATION
(Printout)
• This message appears as a
heading on the printout. It
is followed on the printout
by another coded warning
message that specifies the
problem.
C13
EXTREMA ERROR
(Printout)
Response (DR value)
obtained for a calibrator
bottle is not within an
acceptable range:
- bottles misidentified.
- drop is too small.
- calibrator bottle is
reconstituted
improperly.
- Tracking error may have
occurred
ACTION TO TAKE
Respond as instructed for the
coded warning message that
follows this heading.
• Exit cal mode.To clear slides out of
incubator, empty the slide disposal
box and run option 3 (6 cycles)
(VITROS DT60 II Chemistry System
only). After the cycles have
completed, check the slide disposal
box. If the slide disposal box does
not contain exactly one slide then a
tracking error has occurred. Refer
to section 8.3.
• Be sure pipette is clean.
• Repeat calibration with same
calibrators.
• If the same error occurs,
reconstitute new calibrators and
recalibrate.
Rev. 2004-03-30
Operator's Manual
VITROS DT II System
10-1
CODE/MESSAGE
C14
SLIDE GENERATION
ERROR (Display)
EXPLANATION/CAUSE
Run Mode:
• Generation of slide loaded
in the run mode has not
yet been calibrated.
ACTION TO TAKE
Remove the slide and calibrate the
test.
Remove the slide and enter correct
gen. #.
• Operator keyboard error
(if number was entered
manually).
Calibration Mode:
• Incorrect calibrator kit for
the test being calibrated.
o
• Use the correct calibrator kit:
Calibrator to Use
VITROS Specialty
Calibrator Kit
VITROS Isoenzyme
Calibrator Kit
VITROS Calibrator Kit
Test
*Theo&CHE
*CKMB
All Other
*L19 error code will occur on DTSC
II Module.
• Calibration Data Module
(CDM) does not contain
the information required
for the slide generation
being used.
C15
KIT NUMBER NOT
IN MEMORY
(Display)
• Replace with the most current
CDM. Install new CDMs when they
arrive.
Calibrator kit expired.
Check the expiration date on the
calibrator box. Obtain new
calibrator kit, if expired.
Calibrator kit not on CDM
in the analyzer.
Verify that the number entered was
correct. Re-enter if necessary.
Replace with most current CDM.
Be sure to install CDMs when they
arrive.
C17
MISSING BOTTLE
(Display)
• Calibration mode was
exited before all levels
were run for a given test.
Recalibrate the test in question.
Follow proper procedure for all
required levels of calibrator.
If message recurs, call your
10-2
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
CODE/MESSAGE
C18
MONOTONICITY
ERROR (Print out)
EXPLANATION/CAUSE
ACTION TO TAKE
Response (DR value)
obtained for a calibrator
bottle is not within an
acceptable range:
- bottles run out of order.
- drop is too small.
- calibrator bottle is
reconstituted
improperly.
• Exit cal mode. To clear slides out of
incubator, empty the slide disposal
box and run option 3 (6 cycles)
(VITROS DT60 II Chemistry System
only). After the cycles have
completed, check the slide disposal
box. If the slide disposal box does
not contain exactly one slide then a
tracking error has occurred. Refer
to section 8.3.
- Tracking error may have
occurred
• Be sure pipette is clean.
• Repeat calibration with same
calibrators.
• If the same error occurs,
reconstitute new calibrators and
recalibrate.
C19
CDM RECORD
FORMAT ERROR
(Display)
The computer software
will not accept the record
format number of the
CDM.
Damaged CDM or CDM
socket.
Software problem.
C21
INVALID REF FLUID
NO. (Display)
Calibration data module
(CDM) is not programmed
with the generation
number of reference fluid
that you entered.
Operator keyboard error.
Turn analyzer off. Remove the
CDM and reinsert it, or replace
with a new CDM.
Turn analyzer on and wait for it to
reinitialize.
• Check the number on the reference
fluid bottle label. Either replace the
CDM or the reference fluid to
achieve a match.
• Check that the number entered was
correct and reenter if necessary.
• If message recurs, all your
C22
NO N H 3
CALIBRATION
(Printout)
Rev. 2004-03-30
The analyzer is trying to
calibrate for creatinine,
but cannot find the
ammonia result, which
should have already been
calculated.
Operator's Manual
VITROS DT II System
Recalibrate creatinine and
ammonia as stated in the manual.
10-3
10.1.2 Data Storage (D)
CODE/MESSAGE
EXPLANATION/CAUSE
Occurs when there is a
computer malfunction.
D12
EA PROM ERROR
(Display and Printout)
D13
PROM CHECKSUM
ERROR (Display)
• Occurs when there is a
computer malfunction,
either during initialization
or while running option
10.
D14
RAM
MALFUNCTION
• Occurs when a memory
check is unsuccessful.
ACTION TO TAKE
• Call your Customer Support Center.
(Display)
D16
MEMORY ERROR
(Printout)
The correction factors are
lost.
Run option 36 (DT60 II System) or
option 50 (DTSC II Module) to see
if correction factors are in memory.
If the correction factors are 0, enter
the correction factors from a
previous option 36/50 tape using
option 81 (DT60 II System) or 101
(DTSC II Module).
• The calibration data are
lost.
• To determine if calibration data are
in memory:
- enter option 32.
- press CHEM SELECT until desired
chemistry appears on the display.
- press PRINT.
- compare the printout to the
calibration data from a previously
saved printout.
• There was an error in
calibration.
Enter the lost calibration data again
or wet calibrate the DT60 II System,
DTSC II Module, or DTE II Module.
• Refer to option 32.
• Wet calibrate all chemistries if
unable to restore lost calibration
from saved printout.
10-4
Operator's Manual
VITROS DT II System
CODE/MESSAGE
EXPLANATION/CAUSE
D18
MEMORY RESET
(Printout)
D19
MEMORY HAS BEEN
ERASED (Printout)
The correction factors are
lost.
The calibration data are
lost.
ACTION TO TAKE
Call your Customer Support Center.
Run option 36 (DT60 II System) or
option 50 (DTSC II Module) to see
if correction factors are in memory.
If the correction factors are 0, enter
the correction factors from a
previous option 36/50 tape using
option 81 (DT60 II System) or 101
(DTSC II Module).
• To determine if calibration data are
in memory:
- enter option 32.
- press CHEM SELECT until desired
chemistry appears on display.
- press PRINT and compare the
printout to the calibration data
from a previously saved printout.
• Enter the lost calibration data again
or wet calibrate the DT60 II
System, DTSC II Module, or DTE II
Module.
D25
DTSC INTERNAL
RAM FAILURE
(Printout)
There was an error in
calibration.
Wet calibrate all chemistries if
unable to restore lost calibration.
When initializing the
DTSC II Module the
software detects that the
internal memory test has
failed.
Turn the DTSC II Module off and
then back on again, waiting for it to
reinitialize. Repeat any tests that
may have been deleted by turning
the module off. If the problem
recurs, call your Customer Support
Center.
Operator's Manual
VITROS DT II System
10-5
CODE/MESSAGE
D26
DTSC EXTERNAL
RAM FAILURE
(Printout)
D27
DTSC BATTERY RAM
FAILURE (Printout)
D28
DTSC CHECKSUM
. FAILURE (Printout)
EXPLANATION/CAUSE
ACTION TO TAKE
• When initializing the
DTSC II Module, the
software detects that the
external memory test has
failed.
Turn the DTSC II Module off and
then back on again. Wait for it to
may have been terminated by
turning the module off. If the
problem recurs, call your Customer
Support Center.
•The DTSC II Module fails
to write to the battery
backed RAM as expected.
This error can occur at any
time during operation.
• When initializing the
DTSC II Module, the
software detects a
checksum error on its
PROM.
10.1.3 Electrometer (E)
CODE/MESSAGE
E11
RESULTS INVALID
(Printout)
EXPLANATION/CAUSE
ACTION TO TAKE
Check the interface cable.
Repeat the test in question.
If message recurs, callyour
E12
10-6
RESULTS INVALID
(Printout)
Operator's Manual
VITROS DT II System
CODE/MESSAGE
E13
RESULTS INVALID
(Printout)
EXPLANATION/CAUSE
• Improper slide placement.
ACTION TO TAKE
Check that the interface cable and
pipette locator are secure.
Repeat the test in question, making
sure that the slide is inserted
correctly.
E14
RESULTS INVALID
(Printout)
Sample/reference fluid
levels are not adequate in
dual sample cup.
Assure that patient specimen and
reference fluid volumes are
adequate (at least 4 drops of each)
in the dual sample cup.
The DTE II Pipette is not
working properly.
Verify pipette operation and proper
protocol:
- install the tips tightly.
- check fluid levels in tips (both
tips should have nearly equal
fluid volumes). If fluid level is not
even, dispense sample, eject tip,
and insert new tips.
- wipe outside of tips before
dispensing fluid, being careful
not to touch ends with tissue
wipes (which will absorb fluid
from tips).
- 'keep pipette button depressed
after spotting until you remove
pipette from locator or fluid will
be aspirated by pipette back off
slide.
The pipette locator or boot
is not seated correctly.
Remove pipette locator and nose
assembly and make sure rubber
boot is in place. Reposition pipette
locator as it snaps into position.
•The DTE II Interface Cable
Be sure the DTE II Interface Cable
(the cable that connects the DTE II
Module to the back of the DT60 II
System) is seated correctly.
Operator's Manual
VITROS DT II System
10-7
CODE/MESSAGE
E15
E16
EXPLANATION/CAUSE
ACTION TO TAKE
RESULTS INVALID
(Printout)
This message appears
during option 43 along
with the message: El 4
RESULTS INVALID.
• Check the interface cable.
RESULTS INVALID
(Printout)
with the message: E14
RESULTS INVALID.
• It may also appear when
you are running a test.
Check interface cable.
If the message appears while you
are running a test, run the test
again.
E17
RESULTS INVALID
(Printout)
with the message: E14
RESULTS INVALID.
If message recurs at an excessive
frequency, call your Customer
Support Center.
E18
RESULTS INVALID
(Printout)
Check the interface cable.
Support Center.
E19
RESULTS INVALID
(Printout)
Check the interface cable, the
pipette and the pipette locator.
Support Center.
10-8
Operator's Manual
VITROS DT II System
CODE/MESSAGE
E20
A/D OUT OF RANGE
OR BUSY
EXPLANATION/CAUSE
ACTION TO TAKE
Sample/reference fluid
levels are not adequate in
dual sample cup.
Assure that patient specimen and
reference fluid volumes are
adequate (at least 4 drops of each)
in the dual sample cup.
The DTE II Pipette is not
working properly.
Verify pipette operation and proper
protocol:
- install the tips tightly.
- check fluid levels in tips (both
tips should have nearly equal
fluid volumes). If fluid level is not
even, dispense sample, eject tip,
and insert new tips.
- wipe outside of tips before
dispensing fluid, being careful
not to touch ends with tissue
wipes (which will absorb fluid
from tips).
- after spotting, keep the pipette
button depressed until you
remove the pipette from the
locator or fluid will be aspirated
off the slide.
The pipette locator or boot
Remove pipette locator and nose
assembly and make sure rubber
boot is in place. Reposition pipette
locator as it snaps into position.
The DTE II Interface Cable
Be sure the DTE II Interface Cable
(the cable that connects the DTE II
Module to the back of the DT60 II
System) is seated correctly.
Reference fluid is
outdated.
Discard any bottles open longer
than the 30 day stability period.
Operator's Manual
VITROS DT II System
10-9
10.1.4 Instrument Function (F)
CODE/MESSAGE
F12, F14, F16
DT 60 II SLIDE TRANSPORT
ERROR (Printout)
EXPLANATION/CAUSE
A slide jam has been
detected.
ACTION TO TAKE
• Allow "tests in progress" to print
out.
• Raise the pipette locator cover and
check for slide jam. If there is a
jam, remove the jammed slide.
• Check the pressure pad for binds
by moving it up and down.
• Check the heated FORS weight for
binds.
• To clear slides out of incubator,
empty the slide disposal box and
run option 3 (6 cycles) (VITROS
DT60 II Chemistry System only).
After the cycles have completed,
check the slide disposal box. If the
slide disposal box does not contain
exactly one slide then a tracking
error has occurred. Refer to section
8.3.
• Lower the pipette cover and
resume testing when prompted by
the analyzer.
NOTE: When inserting slides into the
DT60 II System, always insert the
slide until the forward movement of
the slide is stopped by the analyzer.
F17
10-10
LINE VOLTAGE TOO
LOW (Printout)
Fluctuation in the internal
power supply.
Operator's Manual
VITROS DT II System
Repeat tests that may have been
deleted by the low line voltage.
Rev. 2004-03-30
CODE/MESSAGE
F18
PRINTER
MALFUNCTION
(Printout)
EXPLANATION/CAUSE
Paper jam occurred during
loading.
ACTION TO TAKE
• Press PRINT on the keyboard. This
may dislodge loose paper bits.
• Remove paper bits from top of
printer.
• Turn the DT60 II System off and
back on again.
• An easy way to load paper:
- remove printer cover by pulling it
up and towards the left, away
from the analyzer.
- cut the remaining paper away
from core and pull the tape
through top of print end.
IMPORTANT: Do not pull tape
backwards! This might damage paper
feeding mechanism.
- Cut corners of the fresh roll and
position roll so that lead edge
faces you and feeds from bottom
of roll. Feed pointed end over
roller and through slot in back of
printer head until you see paper.
Grab paper as it exits top of
printer and pull a short distance
through printer. Touch PRINT on
keyboard overlay to advance
paper.
- Test printer by running option 4.
NOTE: If the paper cannot be
reloaded due to printer malfunction,
test results may be obtained by
pressing the TEST COMPLETE.
To prevent this code, change the
paper when a color strip appears.
Operator's Manual
VITROS DT II System
10-11
CODE/MESSAGE
F19
MECHANISM ERROR
(Printout)
EXPLANATION/CAUSE
A slide jam has been
detected.
ACTION TO TAKE
Allow "tests in progress" to print
out.
Raise the pipette locator cover and
check for slide jam. If there is a
jam, remove the jammed slide.
Check the pressure pad for binds
by moving it up and down.
Run option 3 for three cycles.
Lower the pipette cover and
resume testing when prompted by
the analyzer.
F20
F30
ELECTROM.
POSITION ERROR
(Display)
• DTE II Module
malfunction.
DTSC TRANSFER
MALFUNCTION
(Printout)
• A slide jam has been
detected.
Repeat the test.
• Remove the slide, if visible at the
pickup station. Open the cover, if
necessary, and remove the slide,
then close the cover. Wait for the
DTSC II Module to initialize (five
minutes).
• Run option 108 and follow the
instructions to step the slide
through the slide transport cycle.
F31
SLIDE NOT AT READ
STATION (Printout)
F32
SLIDE NOT AT
BARCODE STATION
(Printout)
• Exit options and resume normal
operation when prompted by the
analyzer.
NOTE: Does not require an operator
response. Respond as instructed to
the coded warning message that
follows.
To reduce slide jams, empty slide
disposal box regularly.
10-12
Operator's Manual
VITROS DT II System
CODE/MESSAGE
F33
DTSC FILTER
POSITION ERROR
(Printout)
EXPLANATION/CAUSE
• DTSC II Module could not
find home on the filter
wheel, or is having
problems with moving
the
f u . .,
, &
filter to the correct
p
'
ACTION TO TAKE
• Check to see that the arm is down
at the read station, or make sure
that a slide is at the read station.
-,., n T c r , u , , , u
,
• Turn the DTSC
II Module off and
.
.x
.
.i. c
turn it on again waiting for it to
reinitialize. Repeat tests that may
have been deleted by turning the
analyzer off.
• Clean the opal plug and sapphire
window.
Operator's Manual
VITROS DT II System
10-13
10.1.5 Temperature (H)
CODE/MESSAGE
EXPLANATION/CAUSE
ACTION TO TAKE
H11
TEMPERATURE
MALFUNCTION
(Display)
• Call your Customer Support Center.
H12
ANALYZER TEMP.
HIGH (Display)
Room temperature too
high.
• Check that the room temperature is
within the range. The analyzer will
not operate if the room temperature
exceeds 29°C (85°F). If necessary,
adjust the room thermostat.
HI 3
ANALYZER TEMP.
LOW (Display)
• Temporary temperature
fluctuation after the
pipette locator cover was
open.
• If the message appeared after the
pipette locator cover was opened
and closed, wait until the
ANALYZER READY message is
displayed.
• If neither of the first two probler..-,
3ms
exists, call your Customer Support
Center.
• Room temperature too
low.
Check that the room temperature is
within the range. The analyzer will
not operate if the room temperature
falls below 15°C(60°F). If
necessary, adjust the room
thermostat.
• Temporary temperature
decrease after the pipette
locator cover was open.
If the message appeared after the
pipette locator cover was opened
and closed, wait until the
ANALYZER READY message is
displayed.
Instrument is still warming
up.
10-14
Operator's Manual
V1TROS DT I! System
If the message appears when the
analyzer is first turned on, wait
until the ANALYZER READY
message is displayed.
If none of the first three problems
exists, call your Customer Support
Center.
CODE/MESSAGE
EXPLANATION/CAUSE
ACTION TO TAKE
H14
ANALYZER TEMP.
LOW (Display)
This is a warning that the
room temperature is too
low. This code will appear
with another, more
specific code.
HI 5
TEMP
MALFUNCTION
(Printout)
Test results printed on the
DTE II Module with this
message were for tests in
progress when the
module's internal
temperature fluctuated
outside its normal
operating range.
H16
DTSC PREHEAT CAP
TOO LOW/TOO
HIGH —
THERMISTOR FAIL
(Printout - only 1
response will print
out)
During continuous
monitoring the DTSC II
Module detects the
preheat temperature is out
of specifications.
Turn the DTSC II Module off then
back on again, waiting for it to
the analyzer off. If the problem
Center.
H17
DTSC PREHEAT
BOTTOM TOO LOW/
TOO HIGH —
THERMISTOR FAIL
(Printout - only 1
response will print
out)
During temperature
monitoring, the DTSC II
Module detects that the
preheat temperature is
outside of specifications.
Adjust the room temperature.
H18
DTSC READ CAP
TOO LOW/TOO
HIGH —
THERMISTOR FAIL
(Printout - only 1
response will print
out)
During temperature
monitoring, the DTSC II
Module detects a problem
with the temperature in
the read station.
Operator's Manual
VITROS DT II System
Adjust the room temperature.
10-15
CODE/MESSAGE
H14-H19 Temperature
Codes
EXPLANATION/CAUSE
Inadequate space around
the analyzer is preventing
air circulation.
ACTION TO TAKE
• Allow air flow between the
modules.
Analyzer air exhaust vents
dirty.
• Clean the vents with a soft-bristled
brush after the instruments are
powered off.
A fan or vent is directed at
the analyzer.
• Divert any direct air flow away
from the analyzer.
NOTE: If these actions fail to resolve
the problem, power the instrument
off and on.
10.1.6 Communications (N)
CODE/MESSAGE
EXPLANATION/CAUSE
• The DT60 II System
cannot queue any more
messages to the DTSC II
Module resulting in
transmission problem.
N11
TRANSMIT QUEUE
FULL (Display)
N12
RECEIVER QUEUE
FULL (Display)
The DT60 II System
cannot receive any more
messages from the DTSC II
Module. Problem with the
processing of messages.
N13
BAD RECEIVER
COMMAND CODE
(Printout)
The message that was sent
from the DTSC II Module
totheDT60 II System was
undefined by the DT60 II
System.
10-16
Operator's Manual
VITROS DT II System
ACTION TO TAKE
• Turn the DTSC II Module off then
"power off" the DT60 II System.
Turn the DT60 II System back on
again then turn on the DTSC II
Module, waiting for it to
Center.
CODE/MESSAGE
EXPLANATION/CAUSE
N14
BAD RECEIVER
PROTOCOL
(Printout)
• The DT60 II System did
not receive the
appropriate response from
theDTSCII Module that it
was expecting.
N15
BAD RATE SLIDE ID
(Printout)
• The DT60 II System
received a reading about a
slide that it does not have
defined.
N16
DTSC READING OUT
OF SYNC (Printout)
N17
SEQUENCE
PROTOCOL ERROR
(Printout)
The DT60 II System
received a reading that is
out of sync with what was
expected; either double
readings or it missed a
reading.
• There is a
communications problem
between the DT60 II
System and DTSC II
Module.
Operator's Manual
VITROS DT II System
ACTION TO TAKE
Turn the analyzer off then on again,
waiting for it to reinitialize. Repeat
any tests that may have been
deleted by turning the analyzer off.
If the problem recurs, call your
Turn the DTSC II Module off then
power off the DT60 II System. Turn
the DT60 II System back on again,
then turn on the DTSC II Module,
waiting for it to reinitialize. Repeat
any tests that may have been
deleted by turning the analyzer off.
If the problem recurs, call your
10-17
10.1.7 Reflectometer (R) DT60II System
CODE/MESSAGE
R11-R17
RESULTS INVALID (Printout)
EXPLANATION/CAUSE
The FORS head is dirty.
The room light is
excessive.
• There is a light leak.
R18
10-18
PROTOCOL ERROR
You tried to run a slide for
creatinine and ammonia
immediately after you ran
a slide for BUN and the
result for BUN was > 40
mg/dL.
Operator's Manual
VITROS DT II System
ACTION TO TAKE
• Clean the FORS Head:
lift the Spotting Station cover to
expose the FORS weight. Lift up
on the weight that covers the
head.
clean the FORS Head with a
cotton swab moistened with
water. Dry with a clean absorbent
cloth before returning the weight
into position over the FORS
Head. Close the spotting station
cover.
Check for excessive room light.
Light fixtures mounted directly
above and in close proximity to the
DT60 II System may affect the
FORS.
Make sure the slide disposal tray
and main cover for the DT60 II
System are in place.
Repeatthe creatinine and ammonia
slides to verify the test results. It is
recommended that for optimum
performance, creatinine and
ammonia testing should not be
performed when a slide for BUN is
in the incubator.
10.1.8 Reflectometer (L) DTSC II Module
CODE/MESSAGE
L11
INVALID RESULTS
(Display)
EXPLANATION/CAUSE
ACTION TO TAKE
The concentration of the
sample is too high.
Dilute the sample using the
appropriate diluent (refer to the
Instructions for Use).
The calibration is
incorrect.
If this code occurs with a high
frequency and diluted samples
produce normal results or another
code, call your Customer Support
Center.
This Substrate Depletion code
indicates that the change in
kinetics for the test occurred too
quickly.
L12,
L13
INVALID RESULTS
(Printout)
The sample has unusual
kinetics, e.g., multiple
myeloma.
• Dilute the sample using the
appropriate diluent (refer to the
Instructions for Use).
Calibration parameters
were entered manually.
• Recalibrate.
NOTE: Enzyme activity may be low,
medium or high.
These codes are designed to flag
samples that contain interfering
substances.
L14
RESULTS INVALID
L15
GAIN OUT OF
LIMITS FILTER
CHANNEL (Printout)
Rev. 2003-10-01
• There is some mechanical
or electrical noise
interfering with the
calculation of the test
result.
Rerun the test. If the problem
Center.
A gain value sent from the
DTSC II Module or a value
that was computed for a
new gain is out of the
prescribed limits.
Turn the analyzer off then clean the
white reference plug and sapphire
window. Turn the analyzer on
again, waiting for the analyzer to
reinitialize. If the problem recurs,
call your Customer Support Center.
Operator's Manual
VITROS DT II System
10-19
CODE/MESSAGE
EXPLANATION/CAUSE
ACTION TO TAKE
L16
MATH ERROR IN
GAIN
CALCULATION —
FILTER CHANNEL
(Printout)
• The analyzer is unable to
calculate new gain values.
waiting for the analyzer to
L17
GAIN READING
OSCILLATING —
FILTER CHANNEL
(Printout)
Gain value is out of range,
either above or below
specification.
waiting for the analyzer to
L18
INVALID DTSC SPOT
(Printout)
The DTSC II Module
detected a spot interrupt
when unexpected. The
slide was spotted too early
before the green LED on
the display was flashing,
or there was no slide at
the spotting station.
If a slide is at the spotting station,
and an invalid spot occurs, the
DTSC II Module will invalidate the
test and process the slide through
the unit. If the slide is in the hold
station (between the pickup and
spotting station), the slide will be
backed out to the pickup station.
Insert a new slide and repeat the
test. If fluid was dispensed at the
spotting station without a slide
present, clean the spotting station.
L19
INVALID DTSC
BARCODE (Printout)
Run Mode:
• Generation of slide loaded
in the run mode has not
yet been calibrated.
Remove the slide and calibrate the
test.
• Operator keyboard error
(if number was entered
manually).
Remove the slide and enter correct
gen. #.
Calibration Mode:
• Use the correct calibrator kit:
• Incorrect calibrator kit for
the test being calibrated.
Calibrator to Use
VITROS Specialty
Calibrator Kit
VITROS Isoenzyme
Calibrator Kit
VITROS Calibrator Kit
Test
*Theo & CHE
*CKMB
All Other
*C14 error code will occur
on DT60 II Module.
Calibration Data Module
(CDM) does not contain
the information required
for the slide generation
being used.
10-20
Operator's Manual
VITROS DT II System
• Replace with the most current
CDM. Install new CDMs when they
arrive.
Rev. 2004-03-30
CODE/MESSAGE
EXPLANATION/CAUSE
ACTION TO TAKE
L20
RATIO WHITE OUT
OF RANGE (Printout)
The read area is dirty.
L21
RATIO BLACK OUT
OF RANGE (Printout)
The black offset reading
has failed its limit check.
L22
RATIO SAMPLE OUT
OF RANGE (Printout)
The read area is dirty.
L23
REFERENCE
VOLTAGE OUT OF
RANGE (Printout)
The reference voltage
reading has failed its limit
check.-
Turn the DT60 II System off then on
again, waiting for the analyzer to
Center.
L27
DTSC COVER OPEN
(Printout)
The cover to the DTSC II
Module is open.
Check to see that the DTSC II
Module cover is properly closed.
The module will then reinitialize (5
minutes). Repeat any tests that may
have been deleted by having the
cover open. If the problem recurs,
call your Customer Support Center
Operator's Manual
VITROS DT II System
• Clean the opal plug and read
window. See section 5 as a
reference.
Rerun the test. If the problem recurs,
10-21
10-22
Operator's Manual
VITROS DT II System
Installation and Site Specifications
The information contained in this section tells how to install the
VITROS DT60 II Chemistry System, VITROS DTE II Module, and the
VITROS DTSC II Module. This information will be primarily used by
your Ortho-Clinical Diagnostics representative and your DT60 II
System dealer when your equipment is initially installed. However,
should you at some time need to move the analyzer and the module,
this section will tell you how to prepare the equipment for a move,
what to consider in selecting a new location for the equipment, and
how to check the instrument's performance after it is reinstalled in a
new site.
11.1 Installation
The DT60 II System will be unpacked and installed by an OrthoClinical Diagnostics representative or other trained personnel.
CAUTION: Do not attempt to install a DT60 II System, DTE II
Module, or a DTSC II Module unless properly trained.
1. Unpack equipment.
Remove the DT60 II System, the DTE II Module, and the DTSC II
Module from the shipping container. Remove packing materials
from the:
DT60 II System
• FORS Weight
• Pressure Pad
• Preheat Station
DTE II Module
• Electrometer Nose Section
• Sample Holder
DTSC II Module
• Operator Access Cover
• Preheat Heater Arm
• Read Station Heater Arm
Operator's Manual
VITROS DT II System
11-1
2. Set up equipment.
Place the DT60 II System, the DTE I! Module, and the DTSC II
Module in the desired location. Position the DTE II Module to the
right of the analyzer, and the DTSC II Module to the left. Do not plug
in the analyzer yet.
If the DTSC II Module is part of the installation then remove the
connector shroud (Part No. 613871). Attach the DTE II Module
cable assembly (Part No. 351572) to the rear of the DT60 II System
chassis, securing it to the chassis with the screws provided. Connect
the DTSC II Module to the adapter box using the DTE II Module's
cable assembly(Part No. 338669) and secure it with the two
connector screws provided.
With the cover of the analyzer up, check to make sure that the 120/
240 switch is in the proper position (120 position for the United
States and Canada, 240 position for Europe). Replace the cover and
secure the cable with the clamp (Part No. 338669).
Insure that the line module/voltage selector is at the proper setting for
the location. The setting may be changed by opening the snap-open
cover of the module and rotating the selector drum to the proper
setting. The voltage selected will appear in the window once the
cover is closed.
3. Check power source and plug the analyzer in.
Please refer to Electrical Requirements, 11.2.3.
Check the line voltage. For the DT60 II System it must be between
105 and 127V ac. Check that the button of the analyzer is in the
OFF position. Then, plug the analyzer into the receptacle. After the
analyzer is plugged in, turn the DT60 II System on and wait while it
goes through a series of self-checks and warms up (approximately 25
minutes).
The DTSC II Module has settings for nominal voltages of 100, 120,
220, and 240V ac (-10% +5%). Check that the ON/OFF button on
the module is in the OFF position. Then plug the module into the
receptacle. After the module is plugged in, turn it on and wait while
it goes through a series of self-checks and warms up (approximately
5 minutes).
NOTE: The DT60 II System must be turned on first before the DTSC II
Module. You do not need to wait for the analyzer to warm up before
using the DTSC II Module.
11 -2
Operator's Manual
VITROS DT II System
4. Calibrate.
Calibrate the DT60 II System, DTE II Module, and DTSC II Module
for all tests.
5. Run a quality control test.
Run a quality control fluid for all tests to verify the calibration.
11.2 Site Specifications
11.2.1 Space Requirements
The analyzer and modules must rest upon a level bench or table
large enough to accommodate the dimensions shown and sturdy
enough to support the equipment's weight. Additional space should
be provided adjacent to the analyzer, to permit easy operation and
servicing.
VITROS DT60 II System:
Width
Depth
Height
Weight
=
=
=
=
47.6cm (18.75 inches)
34.9cm (13.75 inches)
17.1cm (6.75 inches)
Approximately 8.6kg (19 pounds)
VITROS DTE II Module:
Width
Depth
Height
Weight
=
=
=
=
16.5cm (6.5 inches)
Approximately 2.7kg (6 pounds)
VITROS DTSC II Module:
Width
Depth
Height
Weight
= 34.3cm (13.5 inches)
= 35.4cm (13.9 inches)
= 16.5cm (6.5 inches)
= 7.7kg (1 7 pounds)
Operator's Manual
VITROS DT II System
11 -3
Total space required, DT60 II System alone:
Width = 78.7cm (31 inches)
Depth = 55.9cm (22 inches)
Height = 48.3cm (19 inches)
Total space required, DT60 II System and DTE II Module together:
Total space required, DT60 II System and DTSC II Module together:
Width = 127.8cm (50.3 inches)
Total space required, DT60 II System, DTE II Module, and the
DTSC II Module together:
11.2.2 Environmental Requirements (Temperature, Humidity,
and Altitude)
The DT60 II System, DTE II Module, and DTSC II Module are
designed to operate effectively within" the temperature and humidity
ranges typically found in physicians' offices. For effective operation,
the temperature and relative humidity should be within the range
indicated in the accompanying diagram. The figures below the
diagram define the "corners" indicated in the diagram on the next
page.
11-4
Operator's Manual
VITROS DT II System
Humidity
"1
58
133
:
144
:
:
60
I
62
15.6 ' 16.7
64
;
|
I
]
66
; 68
1
|
I
70
17.8 ' 18.9 ' 20.0 '' 21.1
i
!
72
T
,
1
T
1
1""
74
22.2 ' 23.3
289
30.0
:
31.1
Temperature
15.5°C(60°F), 75% RH
©
29.4°C (85°F), 60% RH
15.5°C(60°F), 15%RH
(E) 23.9°C(78°F); 75% RH
29.4°C (85°F), 15% RH
11.2.3 Electrical Requirements
Both the DT60 II System and the DTSC II Module must be plugged
into a properly grounded receptacle. Receptacle grounding should
comply with all applicable electrical safety codes. Proper grounding
is essential to assure proper operation and to minimize the likelihood
of electrical damage to sensitive electronic circuits within the
analyzer and modules. If you are uncertain about your electrical
service, please consult a qualified electrician.
The receptacle should be within 2.4 meters (8 feet) of the analyzer
and DTSC II Module. The receptacle should be capable of supplying
the following current:
Nominal voltage
DT60 II System
DTSC II Module
120 VAC
240 VAC
1 amp
0.5 amp
0.5 amp
0.25 amp
Appliances (refrigerators, freezers, air conditioners, etc.) and other
instruments can affect electrical power quality. These effects may be
minimized by using a separate power circuit exclusively for the
DT60 II System and DTSC II Module.
Operator's Manual
VITROS DT II System
11-5
11.2.4 Refrigerator and Freezer Space
Refrigerator and freezer space of 0.03 cubic meter (1 cubic foot) is
required for storage of slides and test fluids.
11.3 Moving the Analyzer
11.3.1 Relocation Outside the Office
You may find it necessary to relocate the analyzer outside of your
current office. If so, the new location must meet the same space,
electrical, and environmental requirements as the original site.
1. Move the equipment carefully.
Keep the equipment upright, and transport it in the same manner that
you would transport any other type of office equipment. Before
moving the equipment, make sure that no slides remain in the
analyzer or module incubators, and turn the analyzer and DTSC II
Module off.
If the equipment is going to be transported a long distance, make
sure that it is repacked and transported correctly.
2. Set up the equipment and run a quality control test.
After the equipment is set up in the new location, a 30-minute
environmental equilibration is required, followed by a quality
control test for all relevant assays. When the results are within the
acceptable range for your quality control system, the analyzer is
ready to report results.
11.3.2 Relocation Within the Office
At some point, you may find it necessary to relocate the analyzer
within your office after it has been installed. If you do so, the new
location must meet the same space, electrical, and environmental
requirements as the original site.
1. Move the equipment carefully.
Before moving the equipment, make sure that there are no slides in
the incubators of the DT60 II System, DTE II Module, or DTSC II
Module. Turn the analyzer and the DTSC II Module OFF. Take care
when moving the equipment since dropping or jarring could damage
the equipment.
2. Set up the equipment and run a quality control test.
After the equipment is set up in the new location, a 30-minute
environmental equilibration is required, followed by a quality
control test for all relevant assays. When the results are within the
acceptable range for your quality control system, the analyzer is
ready to report results.
11-6
Operator's Manual
VITROS DT II System
Warranty
12.1 New Equipment Warranty VITROS DT II System
1. Warranty Time Period
Ortho-Clinical Diagnostics warrants the VITROS DT60 II System,
VITROS DTE II Module, and VITROS DTSC II Module to function
properly for one year from the date of initial installation, when
installed within one year from date of shipment. This warranty covers
the purchaser of this equipment and anyone else who owns it during
the warranty period.
2. Warranty Repair Coverage
If this equipment does not function properly during the warranty
period, a Customer Technical Services representative will repair the
equipment without charge during normal working hours (usually
8:00 a.m. to 5:00 p.m. Monday through Friday). Such repair service
will include any adjustments and/or replacement of parts required to
maintain your equipment in good working order. Supply items are
billed as required.
Off-hours service is available at overtime rates.
3. How to Obtain Services
Call your Customer Support Center to obtain service.
4. Limitations
Warranty service is limited to the contiguous United States. This
warranty does not cover service or parts for any attachments,
accessories or alterations not marketed by Ortho-Clinical
Diagnostics, nor to correct problems resulting from their use.
Ortho-Clinical Diagnostics makes no other warranties express,
implied, or of merchantability for this equipment.
Repair without charge is OCD's only obligation under this warranty.
OCD will not be responsible for any consequential or incidental
damages resulting from the sale, use, or improper functioning of
this equipment, even if loss or damage is caused by the negligence
or other fault of OCD.
This limitation of liability will not apply to claims for injury to
persons or damage to property caused by the sole negligence or fault
of OCD.
Operator's Manual
VITROS DT II System
12-1
12.2 New Accessory Warranty VITROS DT Pipette and VITROS DTE Pipette
1. Warranty Time Period
Ortho-Clinical Diagnostics warrants the VITROS DT Pipette and the
VITROS DTE Pipette to function properly for one year from date of
purchase. This warranty covers the purchaser of the pipette(s) and
anyone else who owns it during the warranty period.
2. Warranty Repair Coverage
If this equipment does not function properly during the warranty
period, call your Customer Support Center.
3. Limitations
Replacement without charge is OCD's only obligation under this
warranty. Ortho-Clinical Diagnostics will not be responsible for any
consequential or incidental damages resulting from the sale, use, or
improper functioning of this equipment, even if loss or damage is
caused by the negligence or other fault ofOCD.
OCD makes no other warranties, express, implied, or of
merchantability, for this equipment.
12-2
Operator's Manual
VITROS DT II System
CALIBRATION LOG
for VITROS DT II System
Operator.
Date
Calibrator Kit No.
_
Pipette.
Vitros DTE II Module _
_
Pipette.
Exp. Date.
Gen. No.
Reference Fluid Lot No.
Vitros DISC II Module.
Exp. Date.
CDM No..
CLM No. _
•CALIBRATION COEFFICIENTS
SLIDES
Test
Serial Numbers:
VitrosDT60 II System.
Lot Number
—
—
-
—
-
—
-
-
-
-
—
CP#1
CP#2
CP#3
CP#4
DL#1*
DL#3*
QC
Remarks
—
-
—
-
—
—
—
-
-
-
-
—
—
—
—
—
—
—
—
—
—
-
Exp. Date
-
Affix dated Calibration Printout or manually record values in appropriate spaces.
* DTSC il only
Make a photocopy of this log sheet prior to use for additional sheets.
Operator's Manual
VITROS DT II System
Vitros is a trademark of Ortho-Clinical Diagnostics.
13-1
SERVICE LOG
for VITROS DT II System
Vitros DT60 II System Serial Numbers:
Analyzer.
Vitros DTE II Serial Numbers:
Module _
Pipette.
Vitros DTSC II Serial Numbers:
Module _
. Pipette.
Date
Pipette _
Problem Noted
Corrective Action Taken
13-2
Operator's Manual
VITROS ' U System
Initial
5/95. Repr'
i 1/99.
TEST/REAGENT LOG
for VITROSDT II System
REFERENCE FLUID
SLIDES
Date Put
Into Use
Gen.
No.
Lot Number
Test
T
T
T
T
Expiration
Date
Initials
Date
Opened
1
1
T
1 11
! T
T
I
LJ T
T
1
T
1
i
! 1
1
I
! 1
1
1
! 1
1
1 I
1
1 !
1
1
T
T
T
T
T
1
1 i
1
LJ T
T
T
1
1 1
I
LI
T
T
T
1
1
|
I
1 |
!
T
1 T
Exp.
Initials
Date
1
T
T
Gen.
No.
Lot Number
Operator's Manual
VITROS DT II System
1
|
1 1
1
11
13-3
VITROS DT II System Maintenance Log
Maintenance Log
for the VITROS DT System
I Month
I Year
Refer to the "Instrument Care and Cleaning" section of your Operator's ManuaHor more details.
Daily Maintenance
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 1819 20 21 22 23 24 25 26 27 28 29 30 31
Empty slide disposal box(es).
I
Inspect pipettes and clean if
necessary.
I
Initials of person performing
maintenance.
Weekly Maintenance—
DT60
Clean the bar code reader and
the drop detector surface.
Clean pipette locator and visible
slide track area.
Monthly cleaning of the FORS
head is recommended.
DTE
Clean pipette locator and visible
slide track area.
Clean the rubber boot on the
front of the electrometer.
DTSC
Clean the pickup and slide
spotting stations.
Clean the pipette locator.
Clean the slide track.
Clean the reference cap and
the sapphire read window.
Initials of person performing
maintenance.
Supplies Inventory
Check expiration dates and
inventory of the following supplies:
• Slides
• Reference fluid
• Calibrators
• Controls
• Printer paper
Points to consider:
stora e
9
Temperature
Guide -
T
• Do you have enought for the next
month? for the next 6 months?
• Do you have more than one lot
number for any chemistry? Store
new lot numbers separately.
CAT
1 1
JIL
L o tN a
"
•
Sic e
Of
1So>
0
Lo
• Are supplies being stored at the
correct temperature?
Before using this page, please make copies for future use
13-4
Operator's Manual
VITROS DT II System
VITROS DT II System Quality Control Log
CONTROL Lot No.
Note: When the control lot no. changes, use the new control assay sheet to find acceptable ranges and begin a
new control log sheet.
Range
Test name
Date
Control Value
Acceptable?
• • H|HH|
••
^HHi
^H
Corrective Action/Comments
Initials
H H H HHH^HHHHIH^^H ^B
^H
IHHHI i^^HH
HH
^H
• • ^HHH
^^BH^H^^HHBHI ^B
IHBB I^^HH HHHHHHIHHHH ^B
^H
^HiH BHHHHIH
HHH^HIHHHHHH ^B
HI
^^H^^^^^^HBBI^H
^^^^ÎBHHI^^H^^^^H^H^^^HI
I^HHII^^HIHI^^^HHHÎ HH
I^HH B^^HHIî^^HHi^H
BB
HHIH IHIH
^H IHHH I^HII
• • HUH
^HI^^^^^^HH^^^S H I
• • HHIH
^ ^ ^ H H ^ ^ ^ ^ ^ ^ ^ ^ ^ B ^•;
^H IHHH I^HHI ^_^^^^_—^_
HI HHIH HH^H IHI^^^HHIÎ^^^HH
IB HHIHII^HHI ^^^HIHIi^^B^^H^H
^H HHUH
^HI^^H^^^^^^H^H
^H
^H
II^^HI i^^^^^^HHHH^^H
HH^^B
BH îîH
HH^^^^HHHHHIH ^H
HiHH
•1
Before using this page, please make copies for future use.
Operator's Manual
VITROS DT II System
13-5
Levey-Jennings Quality Control Chart for
VITROS DT II System
Gen#_
Date.
Slide Lot #.
Control.
Control Lot #.
Level 1
Date
+2SD =
+1 S D =
Mean =
-1 S D =
-2SD =
Observed T . , . , .
. . . . . . . . . . . . . . . . . . . . . . . . . .
V
a
u
le / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / /
Control Lot #.
Level 2
Date (_
+2 SD =
—
-—
—
+1 SD =
Mean =
—
—
—-
—
ii
-2SD =
\ '
-1 SD =
Observed I I
Value / / . / / / . / / / / / / / . / / . / / / / / / / / / . / / / / / / / /
Corrective Action:
Reviewed: Date
13-6
Signature.
Operator's Manual
VITROS DT II System
Coronary Risk Classification Questionnaire
Please answer the following questions. This information will be used with the Vilros DT60 II Chemistry System.
Name:
Today's Date
Female
Male
Age
Do you smoke or have you quit smoking within the last 12 months?
Are you diabetic?
Yes
Yes
/
Date of Birth:
/
/
/_
No
No
Do you have a history of cardiovascular disease (left-ventricular hypertrophy)?
Yes
No
Not sure
For internal use only
Systolic Blood Pressure
CHOL
HDLC
Notes:
I f Ortho-Clinical Diagnostics
fif4fc company
Please answer the following questions. This information will be used with the Vitros DT60 II Chemistry System.
Name:
Today's Date
Female
Male
Age
Are you diabetic?
Yes
Yes
/
Date of Birth:
/
/
/_
No
No
Yes
No
Not sure
Systolic Blortd Pressure
CHOL
HDLC
Notes:
' Ortho-Clinical Diagnostics
company
Please answer the following questions. This information will be used with the Vitros DT60 II Chemistry System.
Name:
Today's Date
Female
Male
Age
Are you diabetic?
Yes
Yes
/
Date of Birth:
/
/
No
No
Yes
No
Not sure
Systolic Blood Pressure
Notes:
' Ortho:Clinical Diagnostics
company
CHOL
HDLC
/_
13-8
Operator's Manual
VITROS DT II System
C hem
i stry
TABLE OF CONTENTS-DT SLIDES
Instructions For Use
Version
Date
C-355
1.0
2003-10-01
Alkaline Phosphatase
C-337
1.0
2003-04-30
ALTDT
Alanine Aminotransferase
C-336
1.0
2003-10-01
AWIYL DT
Amylase
C-311
1.0
2003-08-11
ASTDT
Aspartate Aminotransferase
C-338
1.0
2003-10-01
BUN/UREA DT
Urea Nitrogen
C-301
1.0
2003-10-01
CaDT
Calcium
C-348
1.0
2003-03-28
CHEDT
Cholinesterase
C-358
1.0
2003-10-01
CHOL DT
Cholesterol
C-304
1.0
2003-03-28
CKDT
Creatine Kinase
C-342
1.0
2003-10-01
CKMB DT
Creatine Kinase MB
C-351
1.0
2003-04-30
CIDT
Chloride
C-309
1.0
2003-10-01
CO 2 DT
Carbon Dioxide
C-308
1.0
2003-08-11
CREA DT
Creatinine (Blank-Corrected
Method)
C-334
1.0
2003-10-01
CRSC DT
Creatinine (Single-Slide Method)
C-353
1.0
2003-04-30
FeDT
Iron
C-371
1.0
2003-10-01
GGTDT
Glutamyltransferase
C-343
1.0
2003-08-11
GLUDT
Glucose
C-300
1.0
2003-08-11
HDLC DT
HDL Cholesterol (Using the
VITROS DT HDL Cholesterol Kit)
C-341_EN
2.0
2004-02-29
HDLC DT
HDL Cholesterol (Using the
VITROS DT Micro HDL
Cholesterol Kit)
C-354_EN
2.0
2004-02-29
K + DT
Potassium
C-306
1.0
2003-03-28
LACDT
Lactate
C-357
1.0
2003-10-01
LDHDT
Lactate Dehydrogenase
C-344
1.0
2003-10-01
LiDT
Lithium
C-372
1.0
2003-08-11
LIPA DT
Lipase
C-356
1.0
2003-04-30
MgDT
Magnesium
C-349
1.0
2003-10-01
Na DT
Sodium
C-307
1.0
2003-10-01
NBIL DT
Neonatal Bilirubin
C-364
1.0
2003-10-01
NH3 DT (AMON) DT
Ammonia
C-333
1.0
2003-10-01
PHOS DT
Phosphorus
C-350
1.0
2003-04-30
Abbreviation
Test Name
ALBDT
Albumin
ALKP DT
+
Rev. 2004-03-30
Pub.
Operator's Manual
VITROS DT II System
No.
14-1
TABIE OF CONTENTS--DT SHOES
Instructions for Use
14-2
Pub. No.
Version
Date
Total Bilirubin
C-305
1.0
2003-10-01
THEO DT
Theophylline
C-347
1.0
2003-10-01
TPDT
Total Protein
C-310
1.0
2003-10-01
TRIG DT
Triglycerides
C-303
1.0
2003-04-30
urCR DT
Urine Creatinine (Single-Slide
Method)
C-373
1.0
2003-10-01
URIC DT
Uric Acid
C-302
1.0
2003-08-11
Abbreviation
Test Name
TBIL DT
DT Calibrator
DT Calibrator
J23110_EN
3.0
2004-03-31
DT Isoenzyme
Calibrator
DT Isoenzyme Calibrator Kit
J23112_EN
2.0
2004-02-29
DT Specialty
DT Specialty Calibrator Kit
J23115_EN
2.0
2004-02-29
DT Control
DT Control
J23111_EN
2.0
2004-02-29
DT Isoenzyme
Control
DT Isoenzyme Control
J23113_EN
2.0
2004-02-29
DT Reference Fluid
DT Reference Fluid
J23114_EN
2.0
2004-02-29
7% BSA
7% BSA
J11460
2.0
2003-07-28
Operator's Manual
VITROS DT II System
Rev. 2004-03-30
Chemistry
AIRDT
INSTRUCTIONS FOR USE
VITROS Chemistry Products ALB DT Slides
Albumin
Intended Use
For in vitro diagnostic use only.
VITROS ALB DT Slides quantitatively measure albumin (ALB) concentration in serum and plasma.
Summary and Explanation of the Test
Of all serum proteins, albumin is present in the highest concentration. It maintains the plasma oncotic pressure and the
transport of many substances. Increased serum albumin may indicate dehydration or hyperinfusion with albumin; a decrease is
found in rapid hydration, overhydration, severe malnutrition and malabsorption, severe diffuse liver necrosis, chronic active
hepatitis, and neoplasia. Albumin is commonly reduced in chronic alcoholism, pregnancy, renal protein loss, thyroid
dysfunction, peptic ulcer disease, and chronic inflammatory diseases.1
Principles of the Procedure
The VITROS ALB DT Slide method is performed using the VITROS ALB DT Slide and the VITROS Chemistry Products
DT Calibrator Kit on VITROS DT60 II Chemistry Systems.
The VITROS ALB DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers.
When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to
albumin from the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color
complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the
concentration of albumin in the sample.
Reaction Sequence
albumin + bromcresol green (BCG)
BCG-albumin complex
Test Type and Conditions
Test Type and Conditions for ALB DT
Test Type
Colorimetric
VITROS DT60 II
Module
DTSC II
Approximate
Incubation Time
3 minutes
Temperature
37°C (98.6°F)
Wavelength
630 nm
Sample Drop
Volume
10 uL
Warnings and Precautions
Take care when handling materials and samples of human origin. Since no test method can offer complete assurance that
infectious agents are absent, consider all clinical specimens, controls, and calibrators potentially infectious. Handle specimens,
solid and liquid waste, and test components in accordance with local regulations and NCCLS Guideline M292 or other
published biohazard safety guidelines.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the instructions
for use for the appropriate VITROS product, or to other manufacturer's product literature.
Version 1.0
Pub.
No. C-355
AlBDT
Albumin
Reagents
Reagents
Slide Diagram
Slide Ingredients
1. Upper slide mount
2. Spreading layer
(beads)
3. Reagent layer
• bromcresol green dye
• buffer, pH 3.1
4. Support layer
5. Lower slide mount
2
Reactive ingredients per cm
I
Bromcresol green dye 104 ng.
Other ingredients
Polymer beads, binders, buffer, and surfactants.
Slide Handling
Do not use slides with damaged or incompletely sealed packaging.
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-28 °C (64 °-82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18"-28 X:
(64 °-82 °F) for >48 hours.
1.
2.
Remove the unopened slide from the box.
\Narm the unopened slide for 15 minutes. Unopened slides that remain in the sealed wrapper may be returned to
refrigerator or freezer storage.
3. Remove the packaging and place the slide into the loading station within 15 minutes after opening.
Slide Storage and Stability
VITROS ALB DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for ALB DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
Until expiration date
<15 minutes
Specimen Requirements
Handle specimens as biohazardous material.
Specimens Recommended
•
•
Serum
Plasma:3
Heparin
IMPORTANT:
Certain collection devices have been reported to affect other analytes and tests.4
Confirm that your collection devices are compatible with this test.
Serum and Plasma
Specimen Collection and Preparation
Collect specimens using standard laboratory procedures. 56
Patient Preparation
• No special patient preparation is necessary.
Special Precautions
• For the effect of hemolysis on test results, refer to "Limitations of the Procedure."
• Albumin concentrations vary with posture. Results from an upright posture may be approximately 0.3 g/dL (3 g/L) higher
than those from a recumbent posture.7
• Centrifuge specimens and remove the serum or plasma from the cellular material within 3 days of collection.8
Pub.
No. C-355
Version 1.0
AIR DT
Testing Procedure
Albumin
Specimen Handling and Storage
• Handle and store specimens in stoppered containers to avoid contamination and evaporation.
• Mix samples by gentle inversion and bring to room temperature, 18°-28°C (64°-82°F), prior to analysis.
Specimen Storage and Stability for ALB DT: Serum
Temperature
Storage
18°-28°C(64°-82°F)
Room temperature
2°-8°C (36°-46°F)
Refrigerated
<-18°C(<0°F)
Frozen
and Plasma 8
Stability
<7 days
<1 month
Indefinite
Testing Procedure
Materials Provided
•
VITROS Chemistry Products ALB DT Slides
Materials Required But Not Provided
•
•
•
•
|
VITROS Chemistry Products DT Calibrator Kit
Quality control materials, such as VITROS Chemistry Products DT Control I & II
Isotonic saline or reagent-grade water
VITROS DT Pipette
•
Refer to the operator's manual for your VITROS DT60 II Chemistry System.
PANT;
Bring all fluids and samples to room temperature, 18°-28°C (64°-82°F), prior to
analysis.
Sample Dilution
If albumin concentrations exceed the system's reportable (dynamic) range:
1. Dilute the sample with one part isotonic saline or reagent-grade water to 10 parts sample.
2. Reanalyze.
3. Multiply the results by 1.1 to obtain an estimate of the original sample's albumin concentration.
|
Calibration
Required Calibrators
VITROS Chemistry Products DT Calibrator Kit, bottles 1, 2, and 4
Calibrator Preparation, Handling, and Storage
Refer to the instructions for use for VITROS DT Calibrator Kit.
Calibration Procedure
When to Calibrate
Calibrate:
• When the slide lot number changes.
• When critical system parts are replaced due to service or maintenance.
• When government regulations require.
- For example, in the USA, CLIA regulations require calibration or calibration verification at least once every six months.
The VITROS ALB DT test may also need to be calibrated:
• If quality control results are consistently outside acceptable range.
• After certain service procedures have been performed.
For additional information, refer to the operator's manual for your VITROS DT60 II Chemistry System.
Calculations
Reflectance from the slide is measured at 630 nm after the fixed incubation time. Once a calibration has been performed for
each slide lot, albumin concentration in unknown samples can be determined using the software-resident endpoint colorimetric
math model and the response obtained from each unknown test slide.
Version 1.0
Pub. No. C-355
3
ALBDT
Albumin
Quality Control
Validity of a Calibration
Calibration parameters are automatically assessed by the VITROS DT60 II Chemistry System against a set of quality
parameters resident within the analyzer software. Failure to meet any of the pre-defined quality parameters results in a failed
calibration. The calibration report should be used in conjunction with quality control results to determine the validity of
a calibration.
Reportable (Dynamic) Range
Reportable (Dynamic) Range for ALB DT
Conventional (g/dL)
1.0-6.0
SI Units (g/L)
10-60
For out-of-range samples, refer to "Sample Dilution."
Traceability of the Calibration
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for albumin are traceable to the Certified NIST (National
Institute of Standards and Technology) Total Protein Standard Reference Material, SRM* (Standard Reference Material) 927c.
The Ortho-Clinical Diagnostics calibration laboratory uses SRM" 927c to assign values to a series of working human albumin
standards prepared from purified human albumin. The working standard series is used to calibrate a bromcresol green albumin
method9 to support value assignment for the VITROS DT Calibrator Kit.
Quality Control
Procedure Recommendations
|
WARNING:
•
•
•
•
•
•
Handle quality control materials as biohazardous material.
Choose control levels that check the clinically relevant range.
Analyze quality control materials in the same manner as patient samples, before or during patient sample processing.
To verify system performance, analyze control materials:
- After calibration.
- According to local regulations or at least once each day that the test is being performed.
- After specified service procedures are performed. Refer to the operator's manual for your VITROS DT60 II System.
If control results fall outside your acceptable range, investigate the cause before deciding whether to report patient results.
For general quality control recommendations, refer to Statistical Quality Control for Quantitative Measurements: Principles
and Definitions; Approved Guideline-Second Edition10 or other published guidelines.
For additional information, refer to the operator's manual for your VITROS DT60II Chemistry System.
Quality Control Material Selection
I
MPORTANT;
I
•
I
•
•
VITROS DT Control I & II are recommended for use with the VITROS DT60 II
Chemistry System. Evaluate the performance of other commercial control fluids for
compatibility with this test before using for quality control.
Control materials other than VITROS DT Controls I & II may show a difference when compared with other albumin methods
if they:
- Depart from a true h uman matrix.
- Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives.
Controls low in carbon dioxide concentration may show a negative bias11 that can be avoided by reconstituting lyophilates
with a bicarbonate diluent instead of water.
Do not use control materials stabilized with ethylene glycol.
Quality Control Material Preparation and Storage
Refer to the instructions for use for VITROS Chemistry Products DT Control I & II or to other manufacturer's product literature.
Pub. No. C-355
Version 1.0
[3 VMTFJCpS
ALBDT
Expected Values and Reporting Units
Albumin
Reference Interval
Reference Interval for ALB DT12
Conventional Units (g/dL)
3.5-5.0
SI Units (g/L)
35-50
Each laboratory should confirm the validity of these intervals for the population it serves.
Reporting Units and Unit Conversion
The VITROS DT60 II Chemistry System may be programmed to report albumin results in conventional and SI units.
Reporting Units and Unit Conversion for ALB DT
Conventional Units
SI Units
g/dL
g/L (g/dL x 10)
Limitations of the Procedure
Known Interferences
The VITROS ALB DT Slide method was screened for interfering substances following NCCLS Protocol EP7.13 The substances
listed in the table, when tested at the concentrations indicated, caused the bias shown.
Known Interfering Substances for ALB DT
Interferent Concentration
Interferent*
Conv. (mg/dL]
Si (g/L)
Hemoglobin
100
200
400
*
Albumin Concentration
Conv. (g/dL)
SI(g/L)
(1.0)
(2.0)
(4.0)
Bias
Conventional
SI
3.5
35
6%
6%
3.5
3.5
35
35
13%
26%
13%
26%
It is possible that other interfering substances may be encountered. These results are representative; however, your results may differ
somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed might not be predictable.
Other Limitations
•
Version 1.0
Certain drugs and clinical conditions are known to alter albumin concentrations in vivo. For additional information, refer to
one of the published summaries.141S
Pub. No. C-355
AlBDT
Albumin
Performance Characteristics
Method Comparison
I
The plots and table show the results of a comparison of samples analyzed on the VITROS DT60 II System with those analyzed
using the bromcresol green dye-binding comparative method.11
Method Comparison for ALB DT: Serum
Conventional Units
SI Units
70y =x
605040
Q
W
O
30 •
20 >
100
0
10
Comparative Method: Bromcresol Green
(9/dL)
20
30
40
50
60
70
Comparative Method: Bromcresol Green
(gfl.)
Method Comparison for ALB DT: Serum
DT60 II System vs.
comparative method
n
Correlation
Slope Coefficient
79
0.98
0.992
Range of
Sample Cone.
Intercept Sy.x
1.4-5.8
0.06
0.14
SI Units (g/L)
Range of
Sample Cone.
Intercept
Sy.x
14-58
0.59
1.44
Precision
Precision was evaluated with quality control materials on the VITROS DT60 II System following NCCLS Protocol EP5.16
The data presented are a representation of test performance and are provided as a guideline. Variables such as sample
handling and storage, reagent handling and storage, laboratory environment, and system maintenance can affect
reproducibility of test results.
Precision for ALB DT: Serum
System
VITROS DT60 II
Conventional Units <g>dL)
Within
Within
Mean
Cone.
Day SD* Lab SD**
2.5
0.02
0.06
4.4
0.04
0.10
SI Units (g/L)
Mean
Cone.
25
Within
Day SD*
0.2
Within
Lab SD**
0.6
44
0.4
1.0
Within
Lab
CV%**
No.
Observ.
No.
Days
2.6
88
22
2.3
88
22
Within Day precision was determined using two runs/day with two replications.
Within Lab precision was determined using a single lot of slides and calibrating weekly.
Pub. No. C-355
Version 1.0
AlBDT
Albumin
References
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Tietz NW (ed). Fundamentals of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 328-329; 1987.
NCCLS. Protection of Laboratory Workers from Instrument Biohazards and Infectious Diseases Transmitted by Blood, Body Fluids and
Tissue; Approved Guideline. NCCLS Document M29 (OSBN 1-56238). NCCLS, Wayne, PA 19087; 1997.
Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR Analyzer, and
Evaluation of "Plasma Separator Tubes (PST)." Clin. Chem. 35:151; 1989.
Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS;
1991.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS;
1991.
Tietz NW. Textbook of Clinical Chemistry. Philadelphia: WB Saunders; 589; 1986.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical Microscopy. Northfield,
IL: College of American Pathologists; 1992.
Doumas BT, Biggs HG. Determination of serum albumin. Standard Methods in Clinical Chemistry. 7:175-188; 1972.
NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline-Second Edition.
NCCLS Document C24. Wayne, PA: NCCLS; 1999.
Corcoran RM, Durnan SM. Albumin Determination by a Modified Bromcresol Green Method. Clin. Chem. 23(4):765; 1977.
Peters T. All about Albumin. San Diego: Academic Press; 256; 1996.
NCCLS. Interference Testing in Clinical Chemistry. NCCLS Document EP7. Wayne, PA: NCCLS; 1986.
Young DS. Effects of Drugs on Clinical Laboratory Tests, ed. 4. Washington D.C.: AACC Press; 1995.
Friedman RB. Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. Wayne, PA: NCCLS;
1992.
Glossary of Symbols
The Glossary of Symbols table defines the symbols used on the VITROS Chemistry Products packaging and on the VITROS
Chemistry Products Assay Sheets.
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use by or Expiration
Date (YYYY-MM-DD)
Authorized Representative
Consult Instructions for
Use
Lot Number
Contains Sufficient for "n"
Tests
Manufacturer's Serial
Number
For In Vitro Diagnostic Use
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Instructions for Use.
Version 1.0
X
Store At or Above
Pub. No. C-355
I
Fragile, Handle with
Care.
VITR_[fi5 0
ALBDT
Revision History
Albumin
Revision History
Date of
Revision
2003-10-01
Version
1.0
Description of Technical Changes*
New format
New organization and sections consistent with IVD Directive
Specimen Storage and Stability - updated stability values
Materials Required But Not Provided and
Sample Dilution - added reagent-grade water
• Quality Control Material Selection - added statements regarding controls low in
carbon dioxide concentration and ethylene glycol
• Known Interferences - updated values
• Method Comparison - updated all data and the plot
• Precision - updated all data
• References - added all except 7
•
•
•
•
The change bars indicate the position of a technical amendment to the text with respect to the previous version of the document.
When this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
policies, as appropriate.
Signature
Obsolete Date
C€
Ortho-Clinical Diagnostics
Mandeville House
62 The Broadway
Amersham
Buckinghamshire HP7 OHJ
England
a ê/hmtm^fotmmn company
VITROS is a trademark of Ortho-Clinical Diagnostics, Inc.
© Ortho-Clinical Diagnostics, Inc., 2003.
All rights reserved. Printed in USA.
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626-5101
Pub. No. C-355
Version 1.0
VITR
Chemistry
ALKP OT
VITROS Chemistry Products ALKP DT Slides
Intended Use
VITROS ALKP DT Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma.
Alkaline phosphatase is present mainly in bone, liver, kidney, intestine, placenta, and lung. Serum alkaline phosphatase may
be elevated in increased bone metabolism, for example, in adolescents and during the healing of a fracture; primary and
secondary hyperparathyroidism; Paget's disease of bone; carcinoma metastatic to bone; osteogenic sarcoma; and Hodgkin's
disease if bones are invaded. Hepatobiliary diseases involving cholestasis, inflammation, or cirrhosis increase alkaline
phosphatase activity; alkaline phosphatase activity may be increased in renal infarction and failure and in the complications of
pregnancy. Low alkaline phosphatase activity may occasionally be seen in hypothyroidism.1
The VITROS ALKP DT Slide method is performed using the VITROS ALKP DT Slide and the VITROS Chemistry Products
DT Calibrator Kit on VITROS DT60/DT60 II Chemistry Systems.
The VITROS ALKP DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. The
spreading layer contains the p-nitrophenyl phosphate substrate and other components needed for the reaction. The ALKP in
the sample catalyzes the hydrolysis of the p-nitrophenyl phosphate to p-nitrophenol at alkaline pH. The p-nitrophenol diffuses
into the underlying layer, and it is monitored by reflectance spectrophotometry. The rate of change in reflection density is
converted to enzyme activity.
Reaction Sequence
p-nitrophenyl phosphate
ALKP
Mg
p-nitrophenol + H3PO4
,AMP
Test Type and Conditions for ALKP DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
400 nm
Sample Drop
Volume
10 |JL
Version 1.0
Pub.
No. C-337
VITRI
A1KPDT
Reagents
Reagents
Slide Diagram
Slide Ingredients
i
Reactive ingredients per cm2
- 2
p-nitrophenyl phosphate 55 ug; 2-amino-2-methyl-1-propanol (AMP) 0.1 mg; and
magnesium sulfate 1.6 ug.
Other ingredients
, 3
,-'
" ~ - -.
Pigment, binders, buffers, surfactants, cross-linking agent and stabilizer.
4
2. Spreading layer (BaSO4)
• magnesium sulfate
• AMP
• p-nitrophenyl phosphate
3. Reagent layer
• buffer, pH 10.5
4. Support layer
5
Slide Handling
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-28°C (64°-82°F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18°-28°C
(64°-82°F) for >48 hours.
1.
2.
Remove the individual slides from the box.
Warm the unopened slide for at least 15 minutes. Unopened slides that remain in the sealed wrapper may be returned to
VITROS ALKP DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for ALKP DT
Slides
Storage Condition
Room temperature
Refrigerated
Frozen
Room temperature
Unopened
Opened
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
I
• Serum
• Plasma:3
IMPORTANT;
Heparin
Certain collection devices have been reported to affect other analytes and tests4
Specimens Not Recommended
•
•
Plasma:5
EDTA
Citrate
Fluoride oxalate
Do not use hemolyzed specimens.
Pub. No. C-337
Version 1.0
|S] VITRJIS
ALKPDT
Testing Procedure
Serum and Plasma
Collect specimens using standard laboratory procedures.6 7
Patient Preparation
Special Precautions
• For the affect of high concentration of bilirubin on test results, refer to "Limitations of the Procedure."
Centrifuge specimens and remove the serum from the cellular material within 4 hours of collection.5
•
•
•
Handle and store specimens in stoppered containers to avoid contamination and evaporation.
Mix samples by gentle inversion and bring to room temperature, 18°-28°C (64°-82°F), prior to analysis.
Specimen Storage and Stability for ALKP DT: Serum and Plasma5
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
18°-28OC(64°-82OF)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<4 days
<4 days
<4 days
Testing Procedure
Materials Provided
•
VITROS Chemistry Products ALKP DT Slides
•
•
•
«
•
|
VITROS Chemistry Products 7% BSA
VITROS DT Pipette
Isotonic saline
•
Refer to the operator's manual for your VITROS DT60/DT60 II Chemistry System.
iMPORTANT:
analysis.
Sample Dilution
If alkaline phosphatase activities exceed the system's reportable (dynamic) range:
1. Dilute with isotonic saline or VITROS 7% BSA.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's alkaline phosphatase activity.
|
Calibration
Version 1.0
Pub. No. C-337
VI"TFj[C|3"S 0
AIKPDT
Quality Control
When to Calibrate
Calibrate:
The VITROS ALKP DT test may also need to be calibrated:
For additional information, refer to the operator's manual for your VITROS DT60/DT60 II Chemistry System.
Calculations
Based on sequential readings of the slide's reflectance at 400 nm over the defined incubation period, a rate of change in
reflectance is determined. This rate is used in the software-resident multi-point rate calibration model to compute enzyme
activity. Once a calibration has been performed for each slide lot, alkaline phosphatase activity in unknown samples can be
determined from the rate of change in reflectance measured for each unknown test slide.
Calibration parameters are automatically assessed by the VITROS DT60/DT60 II Chemistry System against a set of quality
a calibration.
Reportable (Dynamic) Range for ALKP DT
Conventional and SI Units (U/L)
15-1500
I
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for alkaline phosphatase are traceable to the alkaline
phosphatase method recommended by the International Federation of Clinical Chemistry (IFCC),8'9 adapted to a centrifugal
analyzer at 37°C.
Quality Control
|
Handle quality control materials as biohazardous
material.
•
•
•
- After specified service procedures are performed. Refer to the operator's manual for your VITROS DT60/DT60II
System.
•
•
•
Pub.
No. C-337
Version 1.0
ALKPDT
INSTRUCTIONS FOB USE
VITROS DT Control I & II are recommended for use with the VITROS DT60/DT60 II
•
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other alkaline
phosphatase methods if they:
- Depart from a true human matrix.
Enzyme activity might also vary with enzyme source, diluent temperature, and activation time during reconstitution.
Reference Interval
This reference interval is the central 95% of results from an internal study of 273 apparently healthy adults from a working
population (154 females and 119 males).
Reference Interval for ALKP DT
38-126
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report ALKP DT results in conventional and SI units.
Reporting Units for ALKP DT
Conventional and SI Units
U/L
Known Interferences
The VITROS ALKP DT Slide method was screened for interfering substances following NCCLS Protocol EP7." The
substances listed in the table, when tested at the concentrations indicated, caused the bias shown.
Known Interfering Substances for ALKP DT
Interferent*
Bilirubin
Methotrexate
Nitrofurantoin
*
Interferent
Concentration
20 mg/dL
200 ug/mL
40ug/mL
(342 umol/L)
(440 umol/L)
(168 umol/L)
Activity
Average Bias
Conv./SI Units (U/L) Conv./SI Units (U/L)
120
18.0
130
24.0
120
29.0
It is possible that other interfering substances may be encountered. These results are representative;
however, your results may differ somewhat due to test-to-test variation. The degree of interference at
concentrations other than those listed might not be predictable.
Other Limitations
•
•
Version 1.0
Some drugs that have significant light absorbance in the region of 400 nm can cause a spectral interference.
Certain drugs and clinical conditions are known to alter alkaline phosphatase activity in vivo. For additional information,
refer to one of the published summaries.12 13
Pub. No. C-337
ALKPDT
Method Comparison
The plot and table show the results of a comparison of samples analyzed on the VITROS DT60 II Chemistry System with those
analyzed using the Modified IFCC comparative method8 9 adapted to a centrifugal analyzer at 37°C. Testing followed NCCLS
Protocol EP9. r "
Method Comparison for ALKP DT: Serum
Conventional and SI Units .
1600'
1200
800
o
a:
400
800
400
1200
1600
Comparative Method: Modified IFCC
(U/L)
Method Comparison for ALKP DT: Serum
Conventional and SIUnits (U/L)
DT60 II System vs.
comparative method
n
Slope
Correlation Coefficient
Range of Sample Activity
Intercept
Sy.x
94
0.99
0.994
36-1348
5.78
39.10
Precision
Precision for ALKP DT: Serum
System
VITROS DT60 II
Mean Activity
Within Day SD*
Within Lab SD** Within Lab CV%**
No. Observ.
No. Days
113
1.9
3.9
3.5
88
22
446
6.4
12.7
2.9
88
22
Pub.
No. C-337
Version 1.0
|3 VITROS
ALKP DT
References
References
1.
2.
3.
4.
5.
6.
Evaluation of "Plasma Separator Tubes (PST)." Clin. Chem. 35:151-153; 1989.
1991.
7.
1991.
8. Bretaudiere JP, Vassault A, et al. Criteria for establishing a standardized method for determining alkaline phosphatase activity in
human serum. Clin. Chem. 23:2263-2274; 1977.
9. Tietz NW, Rinker AD, Shaw L M. IFCC Methods for the Measurement of Catalytic Concentration of Enzymes, Part 5. IFCC Method for
Alkaline Phosphatase.. J Clin. Chem., Clin. Biochem. 21:731-748; 1983.
10. NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline-Second Edition.
11. NCCLS. Interference Testing in Clinical Chemistry. NCCLS Document EP7. Wayne, PA: NCCLS; 1986.
12. Young DS. Effects of Drugs on Clinical Laboratory Tests, ed. 4. Washington D.C.: AACC Press; 1995.
13. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
14. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document EP9. Wayne, RA:
NCCLS; 1995.
15. NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. Wayne, PA: NCCLS;
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Store At or Below
This end up
Catalog Number or
Product Code
Attention: See
Version 1.0
X
X
Store At or Above
Pub. No. C-337
VITRI
A1KPDT
Revision History
Revision History
Date of
Revision
2003-04-30
*
Version
1.0
New format
Specimen Storage and Stability - updated all stability values
Sample Dilution - added 7% BSA as a diluent
Materials Required But Not Provided - added VITROS DT Pipette
Quality Control Material Selection - added the statement regarding ethylene
glycol
• Limitations of the Procedure - removed theophylline, added bilirubin,
methotrexate, and nitrofurantoin
• Method Comparison - updated comparison values and plot
• Precision - updated all values
• References - added all
•
•
•
•
•
•
Signature
Obsolete Date
C€
REP
Mandeville House
62 The Broadway
Amersham
England
company
Pub. No. C-337
Version 1.0
I Products-
VITRCD5
Chemistry I
AITDT
VITROS Chemistry Products ALT DT Slides
Intended Use
VITROS ALT DT Slides quantitatively measure alanine aminotransferase (ALT) activity in serum and plasma.
Alanine aminotransferase is present in high activity in liver, skeletal muscle, heart, and kidney. Serum ALT increases rapidly in
liver cell necrosis, hepatitis, hepatic cirrhosis, liver tumors, obstructive jaundice, Reye's syndrome, extensive trauma to skeletal
muscle, myositis, myocarditis, and myocardial infarction.1
The VITROS ALT DT Slide method is performed using the VITROS ALT DT Slide and the VITROS Chemistry Products
The VITROS ALT DT Slide is a multilayered, analytical element coated on a polyester support.
spreading layer contains the ALT substrates L-alanine and sodium a-ketoglutarate. Alanine aminotransferase catalyzes the
transfer of the amino group of L-alanine to a-ketoglutarate to produce pyruvate and glutamate. Lactate dehydrogenase (LDH)
then catalyzes the conversion of pyruvate and NADH to lactate and NAD+.
The rate of oxidation of NADH is monitored by reflectance spectrophotometry. The rate of change in reflection density is
proportional to enzyme activity.
Reaction Sequence
alanine + a-ketoglutarate
pyruvate + NADH + H+ —
ALT
pyruvate + glutamate
pyridoxal-5-phosphate
LDH
- > • lactate + NAD*
Test Type and Conditions for ALT DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
340 nm
Sample Drop
Volume
10 ML
Version 1.0
Pub. No. C-336
AITDT
Reagents
Reagents
Slide Diagram
Slide Ingredients
1
2
. 2
Lactate dehydrogenase (porcine muscle, E.C.1.1.1.27) 0.12 U;
L-alanine 0.86 mg; sodium a-ketoglutarate 54 ng; nicotinamide adenine
dinucleotide, reduced 35 ng; and sodium pyridoxal-5-phosphate 11 ^g.
Other ingredients
-
Pigment, binders, buffer, surfactants, cross-linking agent and stabilizer.
5
1. Jpper slide mount
• sodium a-ketoglutarate
• L-alanine
3. leagent layer
buffer, pH 8.0
> lactate dehydrogenase
> NADH
4. Support layer
6. .ower slide mount
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18 °-28 °C (64 °~82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18°-28QC
(64 °-82 °F) for >48 hours.
1.
2.
Warm the unopened slide for 15 minutes. Unopened slides that remain in the sealed wrapper may be returned to
VITROS ALT DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for ALT DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C (64°-82° F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
Serum
Plasma:
EDTA
Heparin
IMPORTANT:
•
Do not use hemolyzed specimens.4
Serum and Plasma
Collect specimens using standard laboratory procedures.56
Patient Preparation
Pub. No. C-336
Version 1.0
ALTDT
Testing Procedure
Special Precautions
Specimen Handling and
V
Storage
•
•
IMPORTANT:
Do not freeze the specimen.
Specimen Storage and Stability for ALT DT: Serum and Plasma7
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C (64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<3 days
<1 week
Not recommended
Testing Procedure
Materials Provided
•
VITROS Chemistry Products ALT DT Slides
•
•
•
.
|
VITROS Chemistry Products 7% BSA or isotonic saline
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If alanine aminotransferase activities exceed the system's reportable (dynamic) range:
1. Dilute the sample with VITROS 7% BSA or isotonic saline.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's alanine aminotransferase activity.
|
Calibration
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-336
ALTDT
Quality Control
The VITROS ALT DT test may also need to be calibrated:
For additional information, refer to the operator's manual for your VITROS DT60/DT60II Chemistry System.
Calculations
activity. Once a calibration has been performed for each slide lot, alanine aminotransferase activity in unknown samples can be
a calibration.
Reportable (Dynamic) Range for ALT DT
3-950
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for alanine aminotransferase are traceable to the alanine
aminotransferase method recommended by the International Federation of Clinical Chemistry (IFCC),8 adapted to a centrifugal
analyzer at 37°C.
Quality Control
|
WARMING:
•
•
•
•
•
•
- After specified service procedures are performed. Refer to the operator's manual for your VITROS DT60/DT60 II
System.
I
IMPORTANT:
|
•
I
*
•
VITROS DT Control I & II are recommended for use with the VITROS DT60/DT60II
Control materials other than VITROS DT Controls I & II may show a difference when compared with other alanine
aminotransferase methods if they:
4
Pub. No. C-336
Version 1.0
ALTDT
Reference Interval
These reference intervals are the central 95% of results from an internal study of 2444 apparently healthy adults (547 females
and 1897 males).
Reference Interval for ALT DT
Conventional and SI Units (U/L) .
13-69 .
Adult
Females
9-52
21-72
Males
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report alanine aminotransferase results in units.
Reporting Units for ALT DT
U/L
Known Interferences
None identified.
Other Limitations
Certain drugs and clinical conditions are known to alter alanine aminotransferase activity in vivo. For additional information,
refer to one of the published summaries.1011
Method Comparison
I
The plot and table show the results of a comparison of samples analyzed on the VITROS DT60 II System with those analyzed
using the VITROS 950 System. Testing followed NCCLS Protocol EP9.'2
Method Comparison for ALT DT: Serum
10110
y = x
3
800 •
600
401) •
o
200
0
200
400
600
800
1000
Comparative Method: VITROS 950 System
(U/L)
Version 1.0
Pub. No. C-336
A1TDT
References
Method Comparison for ALT DT: Serum
Correlation
Range of
Slope Coefficient Sample Activity Intercept
n
DT60 II System vs.
comparative method
59
1.03
0.999
6-863
-3.92
Sy.x
11.22
Precision
Precision was evaluated with quality control materials on the VITROS DT60II System following NCCLS Protocol EP5.13
Precision for ALT DT: Serum
System
VITROS DT60 II
Mean Activity
Within Day SD*
Within Lab SD**
Within Lab CV%**
No. Observ.
No. Days
35
1.6
2.0
5.7
84
21
190
1.7
3.4
1.8
84
21
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests. Washington D.C.: AACC Press; 3-7; 1993.
1991.
1991.
Bergmeyer HU, Horder M, Rej R. Approved Recommendation (1985) on IFCC Methods for the Measurement of Catalytic Concentration
of Enzymes. Part 3. IFCC Method for Alanine Aminotransferase. J. Clin. Chem. Clin. Biochem. 24:481; 1986.
Young DS. Effects of Drugs on Clinical Laboratory Tests, ed. 4. Washington D C : AACC Press; 1995.
Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document EP9. Wayne, PA:
NCCLS; 1995.
1992.
Pub. No. C-336
Version 1.0
ALTDT
Glossary of Symbols
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date (YYYY-MM-DD)
| ec | HEP |
Manufacturer
Store Between
Use
Lot Number
Tests
SN
Number
REF|
Catalog Number or
Product Code
Store At or Below
Attention: See
Version 1.0
^ J
1
Pub.
Store At or Above
No. C-336
I
Care.
Keep Dry
If
This end up
VITRCpB
ALTDT
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
New format
Sample Dilution - added VITROS 7% BSA
• Quality Control Material Selection - added statements regarding enzyme activity
and ethyline glycol
• Reference Interval - updated all data
• Known Interferences - removed statement regarding high total protein
• Method Comparison - updated the comparison and plot
•
•
•
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
efcMtsH company
©Ortho-Clinical Diagnostics, Inc., 2003.
Pub. No. C-336
Version 1.0
(Products
VITRCD5
Chemistry I
AMY1 DT
VITROS Chemistry Products AMYL DT Slides
Amylase
Intended Use
VITROS AMYL DT Slides quantitatively measure amylase (AMYL) activity in serum and plasma.
Amylase is an amylolytic digestive enzyme produced by the exocrine pancreas and salivary glands. Amylase is increased in
acute pancreatitis, pancreatic abscess or pseudocyst, pancreatic trauma, amyloidosis, pancreatic neoplasm, common-bile-duct
obstruction, and after thoracic surgery. Increased amylase activity may be found in mumps parotitis and renal insufficiency.1
The VITROS AMYL DT Slide method is performed using the VITROS AMYL DT Slide and the VITROS Chemistry Products
The VITROS AMYL DT Slide is a multilayered, analytical element coated on a polyester support.
spreading layer contains the dyed starch substrate (dye covalently linked to amylopectin) for the reaction. The amylase in the
sample catalyzes the hydrolysis of this dyed starch into smaller dyed saccharides. These dyed saccharides diffuse into the
underlying reagent layer. The reflection density is proportional to the activity of amylase present in the sample.
Reaction Sequence
amylase
dyed amylopectin
->•
dyed saccharides
Test Type and Conditions for AMYL DT
Test Type
Endpoint
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-311
AMYLDT
Amylase
Reagents
Reagents
Slide Diagram
Slide .Ingredients
2. Spreading layer (BaSO,>)
• dyed amylopectin
• buffer, pH 7.2
3. Reagent layer
• buffer, pH 7.2
4. Support layer
2
I
Dyed amylopectin 320 ug.
Other ingredients
Pigment, binders, buffers, mordant, surfactants and stabilizer.
Slide Handling
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-28 °C (64 "-82 °F), before the wrapper is
opened.
(64°-82°F) for >48 hours.
1.
2.
VITROS AMYL DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for AMYL DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
Serum
Plasma:
iTOTE;
Heparin3
Plasma activities are approximately 20 U/L higher than serum activities.3
Confirm that your collection devices are compatible with this test
•
Plasma:5
Citrate
EDTA
Fluoride oxalate
Pub. No. C-311
Version 1.0
AMY1DT
Testing Procedure
Amylase
Serum and Plasma
Patient Preparation
Special Precautions
•
Storage
•
•
IMPORTANT;
Specimen Storage and Stability for AMYL DT: Serum and Plasma8
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
18O-28°C(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<7 days
<1 month
Not recommended
Testing Procedure
Materials Provided
•
VITROS Chemistry Products AMYL DT Slides
•
•
•
•
Isotonic saline
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If amylase activities exceed the system's reportable (dynamic) range:
1. Dilute the sample with a patient sample with low amylase activity or with isotonic saline.
2. Reanalyze.
3. If necessary, correct for amylase activity in the diluent.
4. Multiply the results by the dilution factor to obtain an estimate of the original sample's amylase activity.
I
Calibration
Version 1.0
Pub. No. C-311
AMVLDT
Amylase
Quality Control
When to Calibrate
Calibrate:
The VITROS AMYL DT test may also need to be calibrated:
Calculations
each slide lot, amylase activity in unknown samples can be determined using the software-resident endpoint colorimetric math
model and the response obtained from each unknown test slide.
a calibration.
Re portable (Dynamic) Range
Reportable (Dynamic) Range for AMYL DT
5-900
I
|
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for amylase are traceable to the paranitrophenol
maltopentaoside method9 at 37°C.
Quality Control
|
WARN i NO;
•
•
•
•
•
•
System.
Pub. No. C-311
Version 1.0
[3 VITROS
AMYLDT
Amylase
I
IMPORTANT;
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other Amylase
methods if they:
Serum controls with porcine or bovine amylase may give lower values that may vary from method to method.11
•
•
•
I
Reference Interval
The serum reference interval is the central 95% of results from an internal study of 98 apparently healthy individuals from a
working population (55 females and 43 males).
No significant differences between results from the male and female populations were observed.
Reference Interval for AWIYL DT
30-110
*
**
Plasma concentrations are approximately
20 U/L higher than serum concentrations.3
Adults; normal intervals for children <1
year old are lower. ' 2
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report Amylase results in conventional and SI units.
Reporting Units for AMYL DT
U/L
Known Interferences
None identified.
Other Limitations
Certain drugs and clinical conditions are known to alter amylase activity in vivo. For additional information, refer to one of the
published summaries. 13 ' u
Version 1.0
Pub. No. C-311
AMY1DT
Amylase
Method Comparison
I
using the Paranitrophenol Maltopentaoside comparative method.9
Method Comparison for AMYL DT: Serum
1000 •
5
I
900 '
800"
700
600 "
500 •
400 '
300
200 •
100 •
1000
200
400
600
800
0
0 Comparative Method: Paranitrophenol Maltopentaoside
(U/L)
Method Comparison for AMYL DT: Serum
Correlation
Range of
Slope Coefficient Sample Activity Intercept Sy.x
n
DT60 II System vs.
comparative method
69
0.98
0.990
42-888
3.89
35.99
Precision
Precision for AMYL DT: Serum
System
VITROS DT60 II
Mean Activity
Within Day SD*
No. Observ.
No. Days
100
4.5
5.2
5.2
88
22
422
13.3
16.1
3.8
88
22
Pub. No. C-311
Version 1.0
AMYLDT
Amylase
References
References
1.
2.
3.
4.
5.
6.
Tietz NW (ed). Fundamentals of Clinical Chemistry, ed. 5. Philadelphia: WB Saunders; 376; 2001.
NCCLS. Procedures for the. Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS;
1991.
7.
1991.
8. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical Microscopy. Northfield,
9. Mauck LA. A Kinetic Colorimetric Method for the Determination of Total Amylase Activity in Serum. Clin. Chem. 31:1007; 1985.
11. Lee VW, Willis C. Activity of Human and Nonhuman Amylases on Different Substrates Used in Enzymatic Kinetic Assay Methods—a
Pitfall in Interlaboratory Quality Control. Am. J. Clin. Path. 77:290-296; 1982.
12. Gillard BK, Simbala JA, Goodnick L. Reference Intervals for Amylase Isoenzymes in Serum and Plasma of Infants and Children. Clin.
Chem. 29:1119; 1983.
13. Young DS. Effects of Drugs on Clinical Laboratory Tests, ed. 4. Washington D C : AACC Press; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Manufacturer
Store Between
Use
Lot Number
Tests
Fragile; Handle with
Care.
CM
OlM
Number
Keep Dry
_ ——
Kti"
Catalog Number or
Product Code
Store At or Below
This end up
Do Not Reuse
Date (YYYY-MM-DD)
Attention: See
Version 1.0
^m
EC I REP I
I
Store At or Above
Pub. No. C-311
VITRI
AMYLDT
Amylase
Revision History
Revision History
Date of
Revision
2003-08-11
*
Description of Technical Changes"
• New format
> New organization and sections consistent with IVD Directive
> Specimen Storage and Stability - updated stability
> Sample Dilution - added isotonic saline as a diluent; removed 2% bovine serum
albumin in saline, pH 7.4
• Method Comparison - updated the data and plot
> References - added all but 3
Version
1.0
Signature
Obsolete Date
C€
REP
Mandeville House
62 The Broadway
Amersham
England
ôfaMOH company
Pub. No. C-311
Version 1.0
[Products-
ViTRmS
Chemistry!
ASTDT
VITROS Chemistry Products AST DT Slides
Intended Use
VITROS AST DT Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma.
Aspartate aminotransferase is present in high activity in heart, skeletal muscle, and liver. Increased serum AST activity
commonly follows myocardial infarction, pulmonary emboli, skeletal muscle trauma, alcoholic cirrhosis, viral hepatitis, and druginduced hepatitis.1
The VITROS AST DT Slide method is performed using the VITROS AST DT Slide and the VITROS Chemistry Products
The VITROS AST DT Slide is a multilayered, analytical element coated on a polyester support.
spreading layer contains the AST substrates aspartate and a-ketoglutarate. In the assay for aspartate aminotransferase, the
amino group of L-aspartate is transferred to a-ketoglutarate in the presence of pyridoxal-5-phosphate (P-5-P) to produce
glutamate and oxaloacetate. Malate dehydrogenase (MDH) then catalyzes the conversion of oxaloacetate and NADH to malate
and NAD*.
The rate of oxidation of NADH is monitored by reflectance spectrophotometry. The rate of change in reflection density is
proportional to enzyme activity in the sample.
Reaction Sequence
aspartate + a-ketoglutarate
AST
oxaloacetate + NADH + H* -
MDH
->•
oxaloacetate + glutamate
- > malate + NAD+
Test Type and Conditions for AST DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
340 nm
Sample Drop
Volume
10 ML
Version 1.0
Pub. No. C-338
ASTDT
Reagents
Reagents
Slide Diagram
Slide Ingredients
-
•
2
1
•
*
Lactate dehydrogenase (porcine muscle, E.C.1.1.1.27) 0.12 U; malate
dehydrogenase (porcine heart, E.C. 1.1.1.3) 0.11 U; sodium aspartate 0.5 mg;
sodium a-ketoglutarate 32 ug; nicotinamide adenine dinucleotide, reduced
36 ug; and sodium pyridoxal-5-phosphate 16 ug.
. -i—-
- s
Other ingredients
Pigment, binders, buffer, surfactants, cross-linking agent and stabilizer.
2. Spreading layer (BaSOJ
sodium u-ketoglutarate
L-aspartate
3. 1Reagent layer
buffer, pH 8.0
lactate dehydrogenase
malate dehydrogenase
NADH
4. Support layer
Slide Handling
Slide Preparation
The slide must reach room temperature, 18 °-28 °C (64 "-82 f), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18 °-28 °C
(64°-82°F) for >48 hours.
1.
2.
VlTROS AST DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for AST DT
Slides
Storage Condition
Unopened
Room temperature
Refrigerated
Frozen
Room temperature
Opened
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
WARMS:
•
•
I
Serum
Plasma:
MPORTANT:
Heparin
Certain collection devices have been reported to affect other analytes and tests.:
•
•
'
•
Plasma:
EDTA
Citrate
Fluoride oxalate
Do not use hemolyzed specimens because of high levels of AST activity in erythrocytes.4
Pub. No. C-338
Version 1.0
AST OT
Testing Procedure
Serum and Plasma
•
•
Due to the very low density of platelets, it is important to centrifuge plasma specimens at a minimum of 1000 X g for a
minimum of ten minutes in order to avoid contamination of plasma with AST derived from platelets.
Patient Preparation
•
No special patient preparation is necessary.
Special Precautions
•
Plasma, specimens must be collected in tubes that are at least half full. Smaller volumes may give falsely high AST
results.7
• Avoid agitation or mixing of plasma samples after centrifugation. Re-suspension of platelets into previously centrifuged
plasma may lead to artificially elevated AST results because of high AST activity in platelets.4
•
•
Specimen Storage and Stability for AST DT: Serum and Plasma8
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C(64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<3 days
<7 days
<3 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products AST DT Slides
•
•
•
.
VITROS DT Pipette
•
I
IMPORTANT:
analysis.
Sample Dilution
If aspartate aminotransferase activities exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's aspartate aminotransferase activity.
|
Calibration
Version 1.0
Pub. No. C-338
AST DT
Quality Control
Refer to the operator's manual for your VlTROS DT60/DT60 II Chemistry System.
When to Calibrate
Calibrate:
The VlTROS AST DT test may also need to be calibrated:
For additional information, refer to the operator's manual for your VlTROS DT60/DT60 II Chemistry System.
Calculations
activity. Once a calibration has been performed for each slide lot, aspartate aminotransferase activity in unknown samples can
be determined from the rate of change in reflectance measured for each unknown test slide.
Calibration parameters are automatically assessed by the VlTROS DT60/DT60 II Chemistry System against a set of quality
a calibration.
Reportable (Dynamic) Range for AST DT
4-950
I
I
Values assigned to the VlTROS Chemistry Products DT Calibrator Kit for aspartate aminotransferase are traceable to the
aspartate aminotransferase method recommended by the International Federation of Clinical Chemistry (IFCC),9 adapted to a
centrifugal analyzer at 37°C.
Quality Control
|
WARNING:
•
•
•
- After specified service procedures are performed. Refer to the operator's manual for your VlTROS DT60/DT60II
System.
•
•
and Definitions; Approved Guideline-Second Edition™ or other published guidelines.
For additional information, refer to the operator's manual for your VlTROS DT60/DT60 II Chemistry System.
•
Pub. No. C-338
Version 1.0
ASTDT
IMPORTANT;
I
•
I
»
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other aspartate
aminotransferase methods if they:
Reference Interval
These reference intervals are the central 95% of results from an internal study of 189 apparently healthy adults from a working
Reference Interval for AST DT
Adult
Females
15-46
Males
17-59
14-36
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report aspartate aminotransferase results in
conventional and SI units.
Reporting Units for AST DT
U/L
Known Interferences
Heparin at activities greater than 50 U/mL cause AST results to be falsely high.7 Refer to "Specimen Collection and
Preparation."
I
Other Limitations
Certain drugs and clinical conditions are known to alter aspartate aminotransferase activity in vivo. For additional information,
Version 1.0
Pub. No. C-338
VITRCpSgJ
ASTDT
Method Comparison
I
The plot and table show the results of a comparison of samples analyzed on the VlTROS DT60 II System with those analyzed
using the VlTROS 950 System. Testing followed NCCLS Protocol EP9.13
Method Comparison for A S T DT: Serum
1000 '
<=!
I
800
600
400 •
o
a.
>
200
200
400
600
800 1000
Comparative Method: VlTROS 950 System
(U/L)
Method Comparison for AST DT: Serum
DT60 II System vs.
950 System
n
Slope
Intercept
Sy.x
73
1.01
0.997
15-848
-8.46
21.68
Precision
Precision was evaluated with quality control materials on the VlTROS DT60 II System following NCCLS Protocol EP5.14
Precision for AST DT: Serum
System
VlTROS DT60 II
Mean Activity
Within Day SD*
40
1.7
193
3.2
3.0
4.1
No. Observ.
No. Days
7.4
84
21
2.1
84
21
Pub. No. C-338
Version 1.0
ASTDT
References
References
1.
2.
3.
4.
5.
Tietz NW(ed). Fundamentals of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 369-371; 1987.
Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests, ed. 2. Washington D C : AACC Press; 3-69, 3-70; 1997.
6.
1991.
1991.
7.
Berg JD, Romano G, Bayley NF, Buckley BWI. Heparin Interferes with Aspartate Aminotransferase Activity Determined in the
Ektachem 700. Clin Chem. 34:174; 1988.
9. Bergmeyer H U, Horder M, Rej R. Approved Recommendation on IFCC Methods for the Measurement of Catalytic Concentration of
Enzymes. Part 2, IFCC Method for Aspartate Aminotransferase. J. Clin. Chem. Clin. Biochem. 24:497-510; 1986.
12. Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D C : AACC Press; 1990.
13. NCCLS. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. NCCLS Document EP9. Wayne, PA:
NCCLS; 1995.
14.
1992.
Glossary of Symbols
Glossary of Symbols
SN
"RIFI
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Version 1.0
X
Store At or Above
Pub. No. C-338
ASTDT
Revision History
Revision History
Date of
Revision
2003-10-01
*
Version
1.0
New format
Specimens Not Recommended - added citrate
and ethylene glycol
• Known Interferences - added statement regarding heparin; removed statement
regarding high total protein
• Method Comparison - updated the comparison and plot
• Precision - upated all values
•
•
•
•
Signature
Obsolete Date
C€
EC
Mandeville House
62 The Broadway
Amersham
England
'Ortho-Clinical Diagnostics
M|jefcMtBn company
Pub. No. C-338
Version 1.0
VITRCDS
Chemistry!
RUN/
UREADT
VITROS Chemistry Products BUN/UREA DT Slides
Urea Nitrogen
Intended Use
VITROS BUN/UREA DT Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) or as urea
(UREA), in serum and plasma.
The major pathway of nitrogen excretion is in the form of urea that is synthesized in the liver, released into the blood, and
cleared by the kidneys. A high serum urea nitrogen occurs in glomerulonephritis, shock, urinary tract obstruction,
pyelonephritis, and other causes of acute and chronic renal failure. Severe congestive heart failure, hyperalimentation, diabetic
ketoacidosis, dehydration, and bleeding from the gastrointestinal tract elevate urea nitrogen. Low urea nitrogen often occurs in
normal pregnancy, with decreased protein intake, in acute liver failure, and with intravenous fluid administration.1
The VITROS BUN/UREA DT Slide method is performed using the VITROS BUN/UREA DT Slide and the VITROS Chemistry
Products DT Calibrator Kit on VITROS DT60/DT60 II Chemistry Systems.
The VITROS BUN/UREA DT Slide is a multilayered, analytical element coated on a polyester support.
Water and nonproteinaceous components then travel to the underlying reagent layer, where the urease reaction generates
ammonia. The semipermeable membrane allows only ammonia to pass through to the color-forming layer, where it reacts with
the indicator to form a dye.
The reflection density of the dye is measured and is proportional to the concentration of urea in the sample.
Reaction Sequence
- > 2NH3 + CO2
H2NCONH2 + H2O
-> dye
NH3 + ammonia indicator
Test Type and Conditions for BUN/UREA DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
.DT60/DT60II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
660 nm
Sample Drop
Volume
10 ML
Version 1.0
Pub.
No. C-301
BUN/UREA DT
Urea Nitrogen
Reagents
Reagents
Slide Diagram
Slide Ingredients
;
yA •
Urease flack beans, E.C.3.5.1.5) 1.2 U and N-propyl-4-(2,6-dinitro-4-chlorobenzyl)quinolonium ethane sulfonate (ammonia indicator) 0.26 mg.
Other ingredients
s
Pigment, binders, buffer, surfactants, stabilizers, chelator and cross-linking agent
2. Spreading layer (TIO2)
3. Reagent layer
• urease
• buffer.pH 7.8
4. Semipermeable membrane
5. Indicator layer
• ammonia indicator
6. Support layer
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18 °-28 °C (64 °-82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18 "-28 °C
(64 °-82 T) for >48 hours.
1.
2.
VITROS BUN/UREA DT Slides are stable until the expiration date on the carton when they are stored and handled as
specified.
Slide Storage and Stability for BUN/UREA DT
Slides
Unopened
Storage Condition
Room temperature
18°-28 'C (64°-82° F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28 'C (64°-82° F)
Opened
Stability
<48 hours
<15 minutes
WAR Mi HQ;
'
•
|
I
•
•
Serum
Plasma:3
EDTA
Meparin
IMPORTANT:
•
Plasma:3
Sodium fluoride (fluoride inhibits the enzyme urease)
Serum and Plasma
•
Patient Preparation
Pub. No. C-301
Version 1.0
RUN/UREA OT
Testing Procedure
Urea Nitrogen
Special Precautions
• For the effect of sample hemolysis on test results, refer to "Limitations of the Procedure."
• Centrifuge serum and plasma specimens and remove the serum from the cellular material within 4 hours of collection.3
Storage
•
•
Specimen Storage and Stability for BUN/UREA DT: Serum and Plasma3
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
18°-28OC(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<1 day
<5 days
<6 months
Testing Procedure
Materials Provided
.
VITROS Chemistry Products BUN/UREA DT Slides
•
•
•
•
VITROS DT Pipette
•
I
IMPORTANT;
Bring all fluids and samples to room temperature, 18°-28°C (64°-82°F), priorto
analysis.
Sample Dilution
If urea nitrogen concentrations exceed the system's reportable (dynamic) range:
1. Dilute the sample with isotonic saline or reagent-grade water.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's urea nitrogen concentration.
Calibration
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-301
BUN/UREA DT
Urea Nitrogen
Quality Control
The VITROS BUN/UREA DT test may also need to be calibrated:
Calculations
each slide lot, urea nitrogen concentration in unknown samples can be determined using the software-resident endpoint
colorimetric math model and the response obtained from each unknown test slide.
a calibration.
Reportable (Dynamic) Range for BUN/UREA DT
Conventional (mg/dL)
1-100
SI Units (mmol/L)
0.4-35.7
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for BUN/UREA are traceable to the Certified
NIST (National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 912a.
The Ortho-Clinical Diagnostics calibration laboratory uses SRM* 912a to calibrate the CDC Urease/GLDH method7 to support
BUN/UREA value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
'
•
•
•
•
•
•
System.
rftftiT:
Control materials other than VITROS DT Controls I & II may show a difference when compared with other urea nitrogen
methods if they:
Some controls that are low in carbon dioxide concentration may show a negative bias (>10% at CO2 <8 mmol/L) that may
be avoided by reconstituting lyophilates with a bicarbonate diluent instead of with water.
Ammonium bicarbonate diluent should not be used as it will cause a positive bias in test results.
Pub. No. C-301
Version 1.0
[S| VITR!
BUN/UREA OT
Urea Nitrogen
•
Proficiency survey samples may show a negative bias similar to controls low in CO2. Contact the testing agency for
instructions because reconstituting with special diluents may affect other analyte values (e.g., reconstituting with sodium
bicarbonate will affect sodium proficiency scores).
Reference Interval
The serum reference interval is the central 95% of results from an internal study of 3160 apparently healthy adults from a
working population (612 females and 2548 males).
Reference Interval for BUN/UREA DT
SI Units (mmol/L)
3.2-7.1
2.5-6.1
Conventional Units (mg/dL)
9-20
7-17
Male
Female
The VITROS DT60/DT60 II Chemistry System may be programmed to report urea nitrogen results in conventional and SI units.
Reporting Units and Unit Conversion for BUN/UREA DT
Conventional Units
SI Units
mmol/L urea (mg/dL urea N x 0.3569)
mg/dL urea N
Known Interferences
• Ammonium ions may cause an increase in measured BUN/UREA value equivalent to the specimen's nitrogen content.9
The VITROS BUN/UREA DT Slide method was screened for interfering substances following NCCLS Protocol EP7.10 The
Known Interfering Substances for BUN/UREA DT
Interferent*
Hemoglobin
*
Interferent
Concentration
50 mg/dL
• (0.5 g/L)
Blood Urea Nitrogen
Concentration
Conv. (mg/dL)
SI (mmol/L)
28
10
Bias
Conv. (mg/dL)
SI (mmol/L)
1.1
0.4
Other Limitations
Certain drugs and clinical conditions are known to alter blood urea nitrogen concentration in vivo. For additional information,
Version 1.0
Pub. No. C-301
BUN/UREA DT
Urea Nitrogen
Method Comparison
I
using the VITROS 950 System. Testing followed NCCLS Protocol EP9.
Method Comparison for BUN/UREA DT: Serum
SI Units
Conventional Units
40
120
3
y =x
100
o
E
Ol
3(1
80
20
60
40
Q
2
10
20
0
20
60
40
100
120
0
10
20
30
40
Comparative Method. VITROS 950 System
(mmol/L)
(mg/dL)
Method Comparison for BUN/UREA DT: Serum
n
DT60 II System vs.
950 System
62
Correlation
Slope Coefficient
0.98
0.998
Range of
Sample Cone.
Intercept
5-89
-0.10
SI Units (mmol/L)
Sy.x
Range of
Sample Cone.
Intercept
Sy.x
1.61
1.8-31.7
-0.03
0.58
Precision
Precision for BUN/UREA DT: Serum
SI Units (mmol/L)
System
VITROS DT60 II
Mean
Cone.
18
Within
Day SD*
0.5
Within
Lab SD**
0.7
Mean
Cone.
6.3
Within
Day SD*
0.18
Within
Lab SD**
0.26
51
1.4
1.9
18.4
0.49
0.69
Within
Lab
CV%**
No.
Observ.
No.
Days
4.1
88
22
3.7
88
22
Pub. No. C-301
Version 1.0
BUN/UREA DT
Urea Nitrogen
References
References
1.
2.
4.
5.
6.
3.
1991.
1991.
7.
Sampson Rl, et al. A coupled-enzyme equilibrium method for measuring urea in serum: optimization and evaluation of the AACC study
group on urea candidate reference method. Clin. Chem. 26:816-26; 1980.
9. Tietz NW(ed). Fundamentals of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 676-679; 1987.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Store At or Below
This end up
Catalog Number or
Product Code
Attention: See
Version 1.0
X
Store At or Above
Pub. No. C-301
VITFJCpS H
BUN/UREA DI
Urea Nitrogen
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
New format
Specimens Recommended - plasma: added EDTA
> Quality Control Material Selection - added data
> Method Comparison - updated all comparisons and the plot
> Precision - updated all data
References - added all
Signature
Obsolete Date
C€
I EC I REP I
Mandeville House
62 The Broadway
Amersham
England
company
Pub.
No. C-301
Version 1.0
Products
Chemistry
CaOT
VITROS Chemistry Products Ca DT Slides
Calcium
Intended Use
VITROS Ca DT Slides qualitatively measure calcium (Ca) concentration in serum and plasma.
Calcium is the major mineral component of bone; 99% of the body's calcium is in bone. Calcium ions play an important role in
the transmission of nerve impulses and in maintaining normal muscle contraction. Abnormal concentrations of serum calcium
may indicate malfunction of the parathyroid glands, bone diseases, carcinoma, malnutrition and malabsorption syndrome,
vitamin D deficiency, overdose with calcium-containing antacids, and renal diseases.1
The VITROS Ca DT Slide method is performed using the VITROS Ca DT Slide and the VITROS Chemistry Products
The VITROS Ca DT Slide is a multilayered, analytical element coated on a polyester support.
bound calcium is dissociated from binding proteins, allowing the calcium to penetrate through the spreading layer into the
underlying reagent layer. There, the calcium forms a complex with Arsenazo III dye, causing a shift in the absorption maximum.
After incubation, the reflection density of the colored complex is measured spectrophotometrically. The amount of colored
complex formed is proportional to the calcium concentration in the sample.
Reaction Sequence
pH5.6
Ca+2 + Arsenazo I
colored complex
Test Type and Conditions for Ca DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
680 nm
Sample Drop
Volume
10 pL
Version 1.0
Pub. No. C-348
VITRJJD5 Q
CaDT
Reagents
Calcium
Reagents
Slide Diagram
Slide Ingredients
1
|
Arsenazo III dye 60 |xg.
|
Other ingredients
Pigment, binders, surfactants, buffer, cross-linking agent and mordant.
. 2
.3
~~ "
.
.
'
-
3. Reagent layer
• Arsenazo III dye
• buffer, pH 5.6
4. Support layer
S. Lower slide mount
~4
•
-
'
Slide Handling
CAUTION:
Slide Preparation
opened.
(64°-82°F) for >48 hours.
1.
2.
VITROS Ca DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for Ca DT
Slides
Storage Condition
Room temperature
18°-28°C(64°-82° F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C(64°-82° F)
Unopened
Opened
Stability
<48 hours
<15 minutes
CAUTION:
Protective gloves manufactured with calcium carbonate powders may cause
elevated test results because of the contamination of sample handling supplies
(for example, pipette tips, transfer pipettes, sample cups and caps). Supplies
that have come in contact with powdered gloves may subsequently contaminate
the test specimen during sample metering.
NOTE:
Gloves labeled as "powder-free" may contain some contaminating powder agents on
the inside of the glove.
Pub. No. C-348
Version 1.0
Ca DT
Testing Procedure
Calcium
•
•
Serum
Plasma:3
Heparin
IMPORTANT:
•
•
Plasma:5
EDTA*
Fluoride oxalate*
Citrate*
"These substances chelate calcium, causing negative bias.5
Do not use blood from patients on EDTA therapy.
Patient Preparation
Special Precautions
• Results from recumbent patients may be 3% lower.8
• Blood collected with stasis may have calcium concentrations 15% higher.8
• Centrifuge specimens and remove the serum and plasma from the cellular material within 2 days of collection.9
•
•
Specimen Storage and Stability for Ca DT: Serum and Plasma
Storage
Room temperature
Refrigerated9
Frozen9
Temperature
18°-28OC(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<4 hours
<22 days
<1 year
Testing Procedure
Materials Provided
. •
VITROS Chemistry Products Ca DT Slides
•
•
•
•
.
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
analysis.
Version 1.0
Pub. No. C-348
VITFJCpIS 0
CaDT
Calcium
Calibration
Sample Dilution
If calcium concentrations exceed the system's reportable (dynamic) range:
1. Dilute with isotonic saline or reagent-grade water.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's calcium concentration.
Calibration
Special Precautions
If the laboratory's ambient temperature has changed ±5°F (±3°C), or more, from the temperature at the time that the calcium
test was calibrated, then the quality-control materials should be checked. If the quality-control materials are out of control,
recalibrate the analyzer for calcium and record the temperature at the time of calibration for future reference.
When to Calibrate
Calibrate:
The VITROS Ca DT test may also need to be calibrated:
Calculations
I
each slide lot, calcium concentration in unknown samples can be determined using the software-resident endpoint colorimetric
I
parameters resident within the analyzer software. The quality control results should be used to determine the validity of
a calibration.
Reportable (Dynamic) Range for Ca DT
Serum
3.00-14.00
SI Units (mmol/L)
0.75-3.49
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for calcium are traceable to the Certified NIST (National
Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 915a. The Ortho-Clinical
Diagnostics calibration laboratory uses SRM® 915a to calibrate the Flame Atomic Absorption Spectroscopy method10 to support
calcium value assignment for the VITROS Chemistry Products DT Calibrator Kit.
Pub. No. C-348
Version 1.0
Ca DT
Quality Control
Calcium
Quality Control
I
•
•
•
•
•
•
- After specified service procedures are performed. Refer to the operator's manual for your VITROS DT System.
and Definitions; Approved Guideline-Second Edition" or other published guidelines.
IMPORTANT:
I
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other calcium methods
if they:
Reference Interval
These reference intervals are based on an external study.12
Reference Interval for Ca DT
8.4-10.2
SI Units (mmol/L)
2.10-2.55
The VITROS DT60/DT60 II Chemistry System may be programmed to report calcium results in conventional and SI units.
Reporting Units and Unit Conversion for Ca DT
Conventional Units
mg/dL
Version 1.0
SI Units
mmol/L (mg/dL x 0.2495)
Pub. No. C-348
CaDT
Calcium
Known Interferences
I
•
*
Blood from patients receiving Hypaque radiographic contrast agent cannot be used.
Suramin, an antiparasitic drug, has been reported to cause a bias of -10% in calcium results at a suramin concentration of
300 ug/mL.13
Other Limitations
•
Keeping the sample in an open container at room temperature may increase the reported calcium concentration by up to
0.4 mg/dL (0.1 mmol/L). Changes are due to the loss of carbon dioxide, which results in an increase in pH of the specimen.
The increase is minimized by anaerobic handling procedures and prompt analysis. Adherence to these procedures is
especially important for pediatric samples where the sample volume is small.
Certain drugs and clinical conditions are known to alter calcium concentration in vivo. For additional information, refer to one of
the published summaries.1'1'15
Method Comparison
The plots and tables show the results of a comparison of samples analyzed on the VITROS DT60 II System with those
analyzed using the Atomic Absorption comparative method.10 Testing followed NCCLS Protocol EP9.16
Method Comparison for Ca DT: Serum
SI Units
Conventional Units
y =x
15
y =x
12
I
9
6
•8
CO
8o
3
!
t
0
15
Comparative Method: Atomic Absorption
(mg/dL)
Comparative Method: Atomic Absorption
(mmol/L)
Method Comparison for Ca DT: Serum
Conventional Units or (mg/dL)
n
DT60 II System vs.
comparative method
77
Correlation
Slope Coefficient
0.98
0.997
Range of
Sample Cone.
3.0-12.9
Pub. No. C-348
Intercept Sy.x
0.21
0.20
SI Units (mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
0.76-3.21
0.05
0.05
Version 1.0
{•I VITRJ
CaDT
Calcium
References
Precision
Precision for Ca DT: Serum
System
SI Units (mmol/L)
Mean
Cone.
Within
Day SD*
Within
Lab SD**
Mean
Cone.
Within
Day SD*
Within
Lab SD**
Within
Lab
CV%**
No.
Observ.
No.
Days
9.1
0.10
0.18
2.26
0.03
0.04
2.0
88
22
11.4
0.09
0.21
2.85
0.02
0.05
1.8
87
22
DT60 II System
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Version 1.0
Tietz NW. Textbook of Clinical Chemistry, ed. 2. Philadelphia: WB Saunders; 66-67,1900; 1994.
NCCLS. Procedures forthe Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS;
1991.
NCCLS. Procedures forthe Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS;
1991.
Tietz NW. Textbook of Clinical Chemistry, ed. 2. Philadelphia: WB Saunders; 60, 80; 1994.
Cali JP, et al. Atomic Absorption. NBS Reference Method (modified). Clin. Chem. 19:1208; 1987.
Tietz NW(ed). Fundamentals of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 947; 1987.
Gregory, et al. Suramin Interferes with Measurements of Total Calcium and Serum Amylase by the Kodak Ektachem 700 Analyzer and
May Inhibit Liver Enzyme Activity. Clin. Chem. 38:2552-2553; 1992.
Young DS. Effects of Drugs on Clinical Laboratory Tests, ed. 4. Washington D C : AACC Press; 1995.
NCCLS; 1995.
1992.
Pub. No. C-348
VITRCpS 0
CaDT
Calcium
Glossary of Symbols
Glossary of Symbols
Glossary of Symbols
Q<J
2
X
Manufacturer
Do Not Reuse
EC I REP I
Auth'orized Representative
m!
Store Between
Use
| LOT |
Date (YYYY-MM-DD)
Lot Number
Tests
QKI
OlN
Number
Keep Dry
REF
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Care.
Revision History
Date of
Revision
2003-03-28
Version
1.0
Specimen Handling and Storage - updated stabilities; removed "Serum should
not be frozen."
• Specimen Collection and Preparation - updated all statements under Special
Precautions
• Limitations of the Procedure - added suramin
• Method Comparison - updated comparison data and plots
• References - added 2, 3, 4, 5, 7, 8, 9, 10, 11, 12, 13, 16, 17
•
•
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
8H company
Pub. No. C-348
Version 1.0
viTRras
Chemistry!
CHEOT
VITROS Chemistry Products CHE DT Slides
Cholinesterase
Intended Use
VITROS CHE DT Slides quantitatively measure cholinesterase (CHE) activity in serum and plasma.
There are two types of cholinesterase:
• Acetylcholinesterase (EC.3.1.1.7), which is found in red blood cells and nerve tissues.
• Cholinesterase (E.C.3.1.1.8), which is found in plasma, liver, heart, and other tissues.
These measurements are useful in the diagnosis of pesticide poisoning, liver diseases and sensitivity to succinylcholine
administration.12
• Pesticide poisoning. Organophosphate and carbamate pesticides are inhibitors of both cholinesterase and
acetylcholinesterase. Although the toxic effect is caused by inhibition of acetylcholinesterase in nerve endings,
cholinesterase is often used clinically because it is present in serum in high activities and is easy to measure.
• Liver diseases. Cirrhosis, hepatitis, and carcinoma with metastasis to the liver are known to lower cholinesterase activity.
A decrease in CHE activity is considered a sensitive measure of a drop in liver synthetic capacity, because high activities of
cholinesterase are normally present in serum.
• Sensitivity to succinylcholine administration. Succinylcholine is a short-acting muscle relaxant administered during
surgery. It is a reversible inhibitor of acetylcholinesterase and is hydrolyzed by serum cholinesterase. Individuals without
sufficient serum cholinesterase activity or with certain genetic variants may be unable to metabolize the drug quickly,
resulting in prolonged apnea. Low CHE activities may be chronic for the individual or transient due to pesticide exposure,
liver disorder, pregnancy, or the use of oral contraceptives.
The VITROS CHE DT Slide method is performed using the VITROS CHE DT Slide and the VITROS Chemistry Products
DT Specialty Calibrator Kit on VITROS DT60/DT60 II Chemistry Systems.
The VITROS CHE DT Slide is a multilayered, analytical element coated on a polyester support.
Cholinesterase hydrolyzes butyrylthiocholine to thiocholine. The liberated thiocholine reduces potassium hexacyanoferrate III
(potassium ferricyanide) to potassium hexacyanoferrate II (potassium ferrocyanide). The rate of color loss is monitored by
reflectance spectrophotometry. The rate of change in reflection density is proportional to the cholinesterase activity in the
sample.
Reaction Sequence
butyrylthiocholine + H2O
CHE
2 thiocholine + 2 potassium ferricyanide
thiocholine + butyrate
dithiobis(choline) + 2 potassium ferrocyanide
Test Type and Conditions for CHE DT
Test Type
Rate
Version 1.0
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Pub. No. C-358
Temperature
37°C (98.6°F)
Wavelength
400 nm
Sample Drop
Volume
10 ML
CHEDT
Cholinesterase
Reagents
Slide Diagram
Slide Ingredients
— 1
2
I
Potassium ferricyanide 180 ug and butyrylthiocholine iodide 290 ug.
2
y'
3
..-
Other ingredients
Pigment, binders, buffer, surfactants and cross-linking agent.
• butyrylthiocholine iodide
3. Reagent layer
« potassium ferricyanide
• buffer, pH 7.6
4. Support layer
Slide Handling
CAUTSQN:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18"-28 °C (64 °-82 °F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS CHE DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CHE DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Frozen
<-18°C(<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
WA R H! N S:
•
•
I
I
Serum
Plasma:
IMPORTANT:
Heparin
Certain collection devices have been reported to affect other anaiytes and tests.4
•
Do not use visibly hemolyzed specimens.5
Pub. No. C-358
Version 1.0
[¥J V I T R I
CHEDT
Testing Procedure
Cholinesterase
Serum and Plasma
Collect specimens using standard laboratory procedures. 6 '
Patient Preparation
Special Precautions
•
41N6:
•
•
Specimen Storage and Stability for CHE DT: Serum and Plasma8
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<6 hours
<7 days
Not recommended
Testing Procedure
Materials Provided
•
VITROS Chemistry Products CHE DT Slides
•
•
•
•
I
VITROS Chemistry Products DT Specialty Calibrator Kit
VITROS DT Pipette
•
IMPORTANT:
Bring all fluids and samples to room temperature, 18°-28°C (64°-82°F), priorto
analysis.
Sample Dilution
If cholinesterase activities exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's cholinesterase activity.
I
Calibration
VITROS Chemistry Products DT Specialty Calibrator Kit, bottles 1, 2, and 4
Refer to the instructions for use for VITROS DT Specialty Calibrator Kit.
Version 1.0
Pub. No. C-358
GHEDT
Cholinesterase
Quality Control
When to Calibrate
Calibrate:
The VITROS CHE DT test may also need to be calibrated:
Calculations
activity. Once a calibration has been performed for each slide lot, cholinesterase activity in unknown samples can be
a calibration.
Reportable (Dynamic) Range for CHE DT
Conventional (U/mL)
SI Units (U/L)
200-12500
0.20-12.50
I
Values assigned to the VITROS Chemistry Products DT Specialty Calibrator Kit for cholinesterase are traceable to the
butyrylthiocholine-based ferricyanide cholinesterase method recommended by the German Society for Clinical Chemistry,9
measured on a centrifugal analyzer at 37°C.
Quality Control
|
WARMING:
•
•
•
System.
•
•
•
Pub.
No. C-358
Version 1.0
CHEDT
Cholinesterase
IMP
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other cholinesterase
methods if they:
Reference Interval
Reference Interval for CHE DT
Conventional Units
(U/mL)
5.90-12.22
4.65-10.44
Male
Female
SI Units
(U/L)
5900-12220
4650-10440
The VITROS DT60/DT60 II Chemistry System may be programmed to report cholinesterase results in conventional and
SI units.
Reporting Units and Unit Conversion for CHE DT
Conventional Units
SI Units
U/mL
U/L (U/mL x 1000)
Known Interferences
The VITROS CHE DT Slide method was screened for interfering substances following NCCLS Protocol EP7.11 The substances
Known Interfering Substances for CHE DT
Interferent*
Procainamide
Phenazopyridine
*
Bias
Conv. (U/mL)
SI (U/L)
4 mg/mL
17 mmol/L
6.5
6500
-0.48
-477
10 mg/mL
42 mmol/L
3.2 (.imol/L
6.5
4.5
6500
4500
-1.05
-0.74
-1050
3.2 |.imol/L
6.5
6.0
6500
-0.73
6000
-1.11
-730
-1114
80 ug/dL
80 ng/dL
300 (.ig/mL
L-dopa
Cholinesterase Activity
Conv. (U/mL)
SI (U/L)
Interferent
Concentration
1.5 mmol/L
-740
Other Limitations
•
•
Version 1.0
Low pH (6.8) causes a 15% negative bias.
Certain drugs and clinical conditions are known to alter cholinesterase activity in vivo. For additional information, refer to
one of the published summaries.12 13
Pub. No. C-358
GHEDI
Cholinesterase
Method Comparison
I
using the VITROS 950 System. Testing followed NCCLS Protocol EP9.14
Method Comparison for CHE DT: Serum
SI Units
Conventional Units
I
] 5000
V =
15
l2
3
12000 9000
CO
6000
&
to
t
>
3
6
9
12
3000
0
3000
6000
9000
12000
15000
(U/L)
(U/mL)
Method Comparison for CHE DT: Serum
n
DT60 II System vs.
950 System
73
Conventional Units (U/mL)
SI Units (U/L)
Correlation
Range of
Range of
Slope Coefficient Sample Activity Intercept Sy.x Sample Activity Intercept
1.03
0.998
1.44-12.13
0.13
0.17
1436-12130
Sy.x
131.01
172.77
Precision
Precision for CHE DT: Serum
System
VITROS DT60 II
Conventional Units (U/mL)
Within
Within
Day SD* Lab S D "
0.02
0.05
0.04
7.39
0.11
Mean
Activity
3.76
SI Units (U/L)
Within
Within
Day SD* Lab SD**
23.2
52.8
7391
38.8
105.8
Mean
Activity
3760
Within
Lab
CV%**
No.
Observ.
1.4
88
22
1.4
88
22
No.
Days
Pub.
No. C-358
Version 1.0
CHEDT
References
Cholinesterase
References
1.
MossDW, Henderson AR, Kachman JF. Enzymes. In Textbook of Clinical Chemistry, NWTietz, ed., Philadelphia, PA: WB Saunders;
2.
3.
4.
5.
6.
Trundle D, and Marcial G. Detection of Cholinesterase Inhibition. Annals of Clinical and Laboratory Science. 5:345-352, 1988.
Tissue; Approved Guideline. NCCLS Document M29 (OSBIM 1-56238). NCCLS, Wayne, PA 19087; 1997.
7.
8.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical Microscopy. Northfieid,
Method recommended by the "Working Group on Enzymes of the German Society for Clinical Chemistry", European Journal of Clinical
Chemistry, Clinical Biochemistry. 30:163-170; 1992.
NCCLS; 1995.
746-751, 1986.
1991.
1991.
9.
10.
11.
12.
13.
14.
15.
1992.
Glossary of Symbols
Glossary of Symbols
Version 1.0
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Pub. No. C-358
CHEDT
Revision History
Cholinesterase
Revision History
Date of
Revision
2003-10-01
•
Version
1.0
• New format
• New organization and sections consistent with IVD Directive
• Materials Required But Not Provided
Sample Dilution - added VITROS 7% BSA; removed reagent-grade water
> Known Interfering Substances table - removed ibuprofen; updated values
• Method Comparison - updated all comparisons and the plot
> Precision -updated data
> References - added all except 13
Signature
Obsolete Date
C€
REP
Mandeville House
62 The Broadway
Amersham
England
Pub. No. C-358
Version 1.0
Chemistry
CHOIDT
VITROS Chemistry Products CHOL DT Slides
Cholesterol
Intended Use
VITROS CHOL DT Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma.
Cholesterol is present in tissues and in serum and plasma either as cholesterol or as cholesterol esters bound to proteins.
Cholesterol is an essential structural component of cell membranes and the outer layer of plasma lipoproteins and is the
precursor of all steroid hormones, including sex and adrenal hormones, bile acids, and vitamin D.
Cholesterol measurements are used to evaluate the risk of developing coronary artery occlusion, atherosclerosis, myocardial
infarction, and cerebrovascular disease. Coronary atherosclerosis correlates with a high cholesterol level. Cholesterol
concentrations are increased in primary hypercholesterolemia; secondary hyperlipoproteinemia, including nephrotic syndrome;
primary biliary cirrhosis; hypothyroidism; and in some cases diabetes mellitus. Low cholesterol concentrations may be found in
malnutrition, malabsorption, advanced malignancy, and hyperthyroidism. Serum cholesterol concentration depends on many
factors, including age and gender.1
The VITROS CHOL DT Slide method is performed using the VITROS CHOL DT Slide and the VITROS Chemistry Products
The VITROS CHOL DT Slide is a multilayered, analytical element coated on a polyester support. The method is based on an
enzymatic method similar to that proposed by Allain et al.2
Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters from
lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol ester
hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen
peroxide. Finally, hydrogen peroxide oxidizes a leuco dye in the presence of peroxidase to generate a colored dye.
The density of dye formed is proportional to the cholesterol concentration present in the sample and is measured by reflectance
spectrophotometry.
Reaction Sequence
cholesterol + cholesterol esters + proteins
lipoprotein
cholesterol esters + H2O
cholesterol ester hydrolase
cholesterol oxidase
cholesterol + O2
cholest-4-en-3-one + H2O2
peroxidase
H2O2 + leuco dye
cholesterol + fatty acids
- > dye + 2H2O
Test Type and Conditions for CHOL DT
Test Type
Colorimetric
Version 1.0
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Pub.
No. C-304
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
CHOL DT
Cholesterol
Reagents
Slide Diagram
Slide Ingredients
2
I
2
Triton X-100 0.8 mg; cholesterol oxidase (Nocardia E.C.1.1.3.6) 0.2 U;
,
-
.
.
- .
cholesterol ester hydrolase (Candida rugosa, E.C.3.1.1.13) 0.7 U;
peroxidase (horseradish root, E.C. 1.11.1.7) 5.3 U; and 2-(3,5-dimethoxy4-hydroxyphenyl)-4,5-bis-(4-dimethylaminophenyl) imidazole (leuco dye) 0.2 mg.
*
•
"
•
"
"
"
>
•
>
"
—
•
—
•
'
'
-
-
>
»
•
—
,
•
Triton X-100
cholesterol ester
hydrolase
cholesterol oxidase
peroxidase
leuco dye
3. leagent layer
• buffer, pH 6.25
4. Support layer
Other ingredients
Pigment, binder, buffer, surfactants, stabilizers and cross-linking agent.
Slide Handling
Slide Preparation
IMPORTANT:
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS CHOL DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CHOL DT
Slides
Unopened
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°Fl
Room temperature
18°-28°C (64°-82°F)
Opened
Stability
<48 hours
<15 minutes
G:
•
•
Serum
Plasma:
IMPORTANT:
Heparin
Pub.
No. C-304
Version 1.0
CHO1DT
Testing Procedure
Cholesterol
Plasma:5
•
Fluoride oxalate
EDTA
Sodium citrate
Serum and Plasma
Patient Preparation
Special Precautions
•
Storage
•
•
Specimen Storage and Stability for CHOL DT: Serum and Plasma8
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
18O-28OC(64°-82°F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
Not recommended
<3 days
<3 weeks
Testing Procedure
Materials Provided
.
VITROS Chemistry Products CHOL DT Slides
•
•
•
•
.
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If cholesterol concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's cholesterol concentration.
Calibration
Version 1.0
Pub. No. C-304
CHOLDT
Cholesterol
Quality Control
When to Calibrate
Calibrate:
• ' When critical system parts are replaced due to service or maintenance.
The VITROS CHOL DT test may also need to be calibrated:
Calculations
each slide lot, cholesterol concentration in unknown samples can be determined using the software-resident endpoint
a calibration.
Reportable (Dynamic) Range for CHOL DT
50-325
SI Units (mmol/L)
1.3-8.4
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for cholesterol are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 911b. The
Ortho-Clinical Diagnostics calibration laboratory uses SRM19 911b to calibrate the Centers for Disease Control (CDC) Modified
Abell-Kendall method9 to support cholesterol value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
•
•
•
t
•
•
Analyze quality control materials in the same manner as patient samples, before or during patient sample processing. .
Pub. No. C-304
Version 1.0
CHOIDT
Cholesterol
IMPORTANT;
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other Cholesterol
methods if they:
Reference Interval
This reference interval is recommended by NCEP.1
Reference Interval for CHOL DT
<200
200-239
>240
Desirable
Borderline High
High
SI Units (mmol/L)
<5.2
5.2-6.2
>6.2
The VITROS DT60/DT60 II Chemistry System may be programmed to report CHOL DT results in conventional and SI units.
Reporting Units and Unit Conversion for CHOL DT
Conventional Units
SI Units
mg/dL
Known Interferences
• Total protein, 9 g/dL (90 g/L), may elevate results by 4.9%.
The VITROS CHOL DT Slide method was screened for interfering substances following NCCLS Protocol EP7." The
Known Interfering Substances for CHOL DT
Interferent*
Gentisic acid
N-acetylcysteine
Ethamsylate
L-Dopa
*
Interferent
Concentration
5 mg/dL
10 mg/dL
3 mg/dL
0.6 mg/dL
(0.32 mmol/L)
(0.61 mmol/L)
(0.114 mmol/L)
(0.030 mmol/L)
Cholesterol Concentration
Conv.
SI
(mg/dL)
(mmol/L)
210
5.4
210
5.4
210
5.4
210
5.4
Bias
Conv.
(mg/dL)
-29
-27
-11
-11
SI
(mmol/L)
-0.8
-0.7
-0.3
-0.3
It is possible that other interfering substances may be encountered. These results are representative; however, your results may
differ somewhat due to test-to-test variation. The degree of interference at concentrations other than those listed might not be
predictable.
Other Limitations
Certain drugs and clinical conditions are known to alter cholesterol concentration in vivo. For additional information, refer to one
of the published summaries.13 u
Version 1.0
Pub. No. C-304
GHOLDT
Cholesterol
Method Comparison
I
The plots and table show the results of a comparison of samples analyzed on the VITROS DT60 II Chemistry System with
those analyzed using the Modified Abell-Kendall comparative method.9 Testing followed NCCLS Protocol EP9.
Method Comparison for CHOL DT: Serum
SI Units
Conventional Units
10
350 i
y =x
g-
300
1
250 H
I
200
w
i
i5
°
°
100
I»
a.
>
0
0
50
100
150
200
250
300
350
2
Comparative Method: Modified Abell-Kendall
(mg/d/L)
4
6
S
10
Comparative Method: Modified Abell-Kendall
Method Comparison for CHOL DT: Serum
n
DT60 II System vs.
comparative method
56
Correlation
Slope Coefficient
1.00
0.997
Range of
Sample Cone.
Intercept Sy.x
56-313
0.75
6.11
SI Units (mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
1.4-8.1
0.02
0.16
Precision
Precision was evaluated with quality control materials on VITROS the DT60 II System following NCCLS Protocol EP5.16
Precision for CHOL DT: Serum
System
VITROS DT60 II
Within
Within
Day SD* Lab S D "
Mean
Cone.
SI Units (mmol/L)
Within
Within
Day SD* Lab SD**
Mean
Cone.
149
3.2
3.5
3.8
0.08
235
3.8
5.0
6.1
0.10
0.09
0.13
Within
Lab
CV%**
No.
Observ.
No.
Days
2.3
88
22
2.1
88
22
Pub. No. C-304
Version 1.0
CHOLDT
References
Cholesterol
References
1.
2.
3.
6.
Allain CC, et al. Enzymatic Determination of Total Cholesterol in Serum. Clin. Chem. 20:470; 1974.
NCEP. Recommendations for improving cholesterol measurement. A report from the Laboratory Standardization Panel of the National
Cholesterol Education Program. NIH Publication No. 90-2964; 1990.
7.
4.
5.
1991.
1991.
8.
9.
Burtis CA, Ashwood ER. eds. Textbook of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 849; 1999.
Duncan IW, Mather A, Cooper GR. The procedure for the proposed cholesterol reference method. Atlanta, GA: Centers for Disease
Control; 1982.
11. NCEP. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of
High Blood Cholesterol in Adults (Adult Treatment Panei III); Executive Summary. NIH Publication No. 01-3670. National
Institutes of Health. Bethesda. Maryland: May, 2001.
NCCLS; 1995.
16.
1992.
Glossary of Symbols
Glossary of Symbols
Manufacturer
Store Between
Use
Lot Number
Tests
Care.
Number
Keep Dry
Store At or Below
This end up
Do Not Reuse
Date (YYYY-MM-DD)
Catalog Number or
Product Code
Attention: See
Version 1.0
j 6c | REP j
¥
Store At or Above
Pub. No. C-304
CHOIDT
Revision History
Cholesterol
Revision History
Date of
Revision
2003-03-28
*
Version
1.0
• New format
• Specimens Not Recommended - added the section
» Serum and Plasma: Special Precautions - "added within 3 hours of collection"
> Specimen Handling and Storage - updated all stabilities
> Quality Control Material Selection - added statement regarding ethylene glycol
• Method Comparison - updated comparison values and plots
> References - added all new references
Signature
Obsolete Date
C€
I EC REPj
ml
Mandeville House
62 The Broadway
Amersham
England
aAtMSH company
Pub. No. C-304
Version 1.0
[Product*
VITRCD5
Chemistry!
CKDT
VITROS Chemistry Products CK DT Slides
Creatine Kinase
Intended Use
VITROS CK DT Slides quantitatively measure creatine kinase (CK) activity in serum and plasma.
Creatine kinase, also referred to as creatine phosphokinase, is a cellular enzyme with a wide tissue distribution. CK is found
mainly in skeletal and cardiac muscle. CK's physiological role is associated with ATP generation for contractile or transport
systems. Serum CK is almost always increased following acute myocardial infarction or skeletal muscle damage. The enzyme
is commonly elevated in myocarditis of any cause, cerebrovascular accidents, rhabdomyolysis, polymyositis, and acute
physical exertion. CK is also increased in the muscular dystrophies; in Duchenne's muscular dystrophy, CK elevations of
20-200 times normal are common. Low CK may reflect decreased muscle mass or muscle wasting. Reference values for CK
must consider the age, gender, and physical activity of the person. Low serum CK activities are common in the elderly, in the
bedridden, and in patients with advanced malignancy.1
The VITROS CK DT Slide method is performed using the VITROS CK DT Slide and the VITROS Chemistry Products
The VITROS CK DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. This
layer also contains W-acetylcysteine (NAC) to activate CK without pretreating the sample.
When the sarnple is deposited on the slide, creatine kinase catalyzes the conversion of creatine phosphate and ADP to
creatine and ATP. In the presence of glycerol kinase (GK), glycerol is phosphorylated to L-a-glycerophosphate by ATP.
Oxidation of L-a-glycerophosphate to dihydroxyacetone phosphate and hydrogen peroxide occurs in the presence of
L-a-glycerophosphate oxidase (a-GPO). Finally, leuco dye is oxidized by hydrogen peroxide in the presence of peroxidase to
form a dye.
Reflection densities are monitored during incubation. The rate of change in reflection density is proportional to enzyme activity.
Reaction Sequence
CK
creatine phosphate + ADP
->•
creatine + ATP
NAC, Mg
GK
glycerol + ATP
L-a-glycerophosphate + ADP
a-GPO
L-a-glycerophosphate + O2
peroxidase
H2O2 + leuco dye
>• dihydroxyacetone phosphate + H2O2
dye + 2H2O
Test Type and Conditions for CK DT
Test Type
Rate
Version 1.0
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Pub. No. C-342
Temperature
37°C (98.6°F)
Wavelength
680 nm
Sample Drop
Volume
10 uL
GKDT
Creatine Kinase
Reagents
Slide Diagram
Slide Ingredients
-
—
•
"
•
1
'
2
s2
L-alpha-glycerophosphate oxidase (Aerococcus viridans, E.C. 1.1.3.21) 0.4 U;
peroxidase (horseradish root, E.C.1.11.1.7) 1.4 U; glycerol kinase (E.coli,
E.C.2.7.1.30) 0.5 U; creatine phosphate 170 ug; N-acetylcysteine 54 ug;
magnesium acetate 20 ug; glycerol 20 ug; 2-(3,5-dimethoxy-4-hydroxyphenyl)4,5-bis-(4-dimethylaminophenyl) imidazole (leuco dye) 20 ug; and adenosine
diphosphate 20 ug.
Other ingredients
... 3
-••"'
*—-
f
—
- - ~S
Jpper slide mount
1-
2
Spreading layer (TiO2)
•
W-acetylcysteine
3. Reagent layer
» buffer, pH ?.O
> adenosine diphosphate
> glycerol, magnesium
acetate
> glycerol kinase, leuco dye
» peroxidase
• glycerophosphate oxidase
» creatine phosphate
4.
Support layer
6. -ower slide mouont
Pigment, binder, buffers, surfactants, inhibitors, stabilizers, cross-linking agent,
dye solubilizer, scavenger and chelator.
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-2B°C (64°-82°F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS CK DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CK DT
Slides
Unopened
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Frozen
<-18°C(<0°F)
Room temperature
18°-28°C (64°-82°F)
Opened
Stability
<48 hours
<15 minutes
v
* ::•! •
•
•
Serum
Plasma:3
IMPORTANT:
Heparin
Certain collection devices have been reported to affect other analytes and tests."
Pub. No. C-342
Version 1.0
CKDT
Testing Procedure
Creatine Kinase
• Do not use grossly hemolyzed specimens.5
Serum and Plasma
Collect specimens using standard laboratory procedures.6 '
Patient Preparation
Special Precautions
• CK is unstable in serum. Centrifuge specimens and remove the serum from the cellular material within 4 hours of
collection.8
Specimen Storage and Stability for CK DT: Serum and Plasma8
Storage
Temperature
Stability
Room temperature
18°-28°C (64°-82°F)
<4 hours
2°-8°C (36°-46°F)
Refrigerated
<5 days
Frozen
<-18°C(<0°F)
<1 month
Testing Procedure
Materials Provided
.
VITROS Chemistry Products CK DT Slides
•
•
•
.
Quality control materials, such as VITROS Chemistry Products DT Control I or VITROS Chemistry Products DT Isoenzyme
Control I and VITROS Chemistry Products DT Control II
VITROS DT Pipette
•
I
IMPORTANT:
analysis.
Sample Dilution
If creatine kinase activities exceed the system's reportable (dynamic) range:
1. Dilute the sample with VITROS 7% BSA.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's creatine kinase activity.
Sample dilution results in higher creatine kinase activities than expected.9
|
|
Calibration
VITROS Chemistry Products DT Calibrator Kit, bottles 1,2, and 4
Version 1.0
Pub. No. C-342
CKDT
Creatine Kinase
Quality Control
When to Calibrate
Calibrate:
The VITROS CK DT test may also need to be calibrated:
Calculations
activity. Once a calibration has been performed for each slide lot, creatine kinase activity in unknown samples can be
determined from the rate of change in reflectance measured for each unknown test slide
a calibration.
Reportable (Dynamic) Range for CK DT
20-1600
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for creatine kinase (CK) are traceable to a modification
of the Scandinavian Committee on Enzymes, recommended method 1011 for the determination of creatine kinase at 37°C.
Quality Control
|
WARNING:
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition''2 or other published guidelines.
Pub. No. C-342
Version 1.0
GKDT
Creatine Kinase
IMPORTANT:
•
|
•
VITROS DT Controls are recommended for use with the VITROS DT60/DT60 II
Control materials other than VITROS DT Controls may show a difference when compared with other creatine kinase
methods if they:
Refer to the instructions for use for VITROS Chemistry Products DT Control I & II and VITROS Chemistry Products
DT Isoenzyme Control I or to other manufacturer's product literature.
Reference Interval
Reference Interval for CK DT13
Females
30-135
55-170
Males
The upper limit of the reference interval is reported to be affected by population characteristics such as the degree of physical
activity" and race.15 Distributions of CK values from normal, healthy subjects often demonstrate a positive skew,16 leading to
variable upper reference limit estimates.
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report creatine kinase results in conventional and
SI units.
Reporting Units for CK DT
U/L
Known Interferences
I
•
Carbon dioxide at a level of 40 mmol/L may cause up to a 30% negative bias in creatine kinase.
Other Limitations
Certain drugs and clinical conditions are known to alter creatine kinase activity in vivo. For additional information, refer to one
of the published summaries 17,18
Version 1.0
Pub. No. C-342
CKDT
Creatine Kinase
Methpd Comparison
I
Method Comparison for CK DT: Serum
IXOO i
y =x
1500 e
1200 •
t
900
a
to
o
600 •
:K)0 •
0
0
300
600
900
1200
1500 1800
(U/L)
Method Comparison for CK DT: Serum
DT60 II System vs.
comparative method
n
Slope
Intercept
Sy.x
53
1.01
0.999
34-1379
11.10
17.24
Precision
Precision for
CKDT: Serum
System
VITROS DT60 II
No Observ.
No. Days
6.1
88
22
3.0
88
22
Mean Activity
Within Day SD*
129
4.0
7.9
813
13.6
24.7
Pub. No. C-342
Version 1.0
CKDT
References
Creatine Kinase
References
1.
2.
4.
5.
6.
Evaluation of "Plasma Separator Tubes (PST)." Clin. Chem. 35:1:151-153; 1989.
7.
8.
Tietz NW(ed). Textbook of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 662; 1999.
Scandinavian Committee on Enzymes: Recommended Method for the Determination of Creatine Kinase in Blood. Scand. J. Clin. Lab.
Invest. 39:1-5; 1979.
Scandinavian Committee on Enzymes: Recommended Method for the Determination of Creatine Kinase in Blood. Scand. J. Clin. Lab.
Invest. 36:711-23; 1976.
Henry JB. Clinical Diagnosis and Management by Laboratory Methods. Philadelphia: WB Saunders; 2088; 1979.
Krahn J. Upper Reference Limit for Creatine Kinase. Clin. Chem. 31(1):158; 1985.
Black HR. Quallich H-D, and Garlect CB. Racial Difference in Serum Creatine Kinase Levels. Amer. J. Med. 81:479-487; 1986.
Miller WG. Chinchilli HD, Nance WD. Sampling from a Skewed Population Distribution as Exemplified by Estimation of the Creatine
Kinase Upper Reference Limit. Clin. Chem. 30(1): 18-23; 1984.
Friedman RB. Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990.
NCCLS; 1995.
3.
1991.
1991.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
1992.
Glossary of Symbols
Glossary of Symbols
Version 1.0
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Pub. No. C-342
CKDT
Revision History
Creatine Kinase
Revision History
Date of
Revision
2003-10-01
*
Version
1.0
New format
Specimens Recommended, Special Precautions - removed the statement
regarding EDTA and fluoride oxilate
• Materials Required But Not Provided and
Sample Dilution - added VITROS 7% BSA; removed isotonic saline
• Sample Dilution - added that dilution may result in higher CK activities than
expected
• Reference Interval - updated the statement regarding the determination of a more
specific reference range
• Known Interferences - added values
• Method comparison - updated all data and the plot
• References - added all except 1, 9,10,14,15,16,13
•
•
•
Obsolete Date
Signature
C€
Mandeville House
62 The Broadway
Amersham
England
« m company
Pub. No. C-342
Version 1.0
Products
VITRCD5
Chemistry
CKMB DT
VITROS Chemistry Products CKMB DT Slides
Creatine Kinase MB
Intended Use
VITROS CKMB DT Slides quantitatively measure creatine kinase MB (CK-MB) activity in serum.
The MB isoenzyme of creatine kinase is found primarily in cardiac muscle; however, trace amounts are present in skeletal
muscle. CK-MB is elevated in acute myocardial infarction, where the test has its greatest use.
CK-MB usually peaks between 12 and 24 hours after myocardial infarction and returns to normal in 48 to 72 hours in an
uncomplicated case. CK-MB is also increased in myocarditis, Duchenne's muscular dystrophy, polymyositis, rhabdomyolysis,
and other myocardial or myopathic disorders.1
The VITROS CKMB DT Slide method is performed using the VITROS CKMB DT Slide and the VITROS Chemistry Products
DT Isoenzyme Calibrator Kit on VITROS DT60/DT60 II Chemistry Systems.
The VITROS CKMB DT Slide is a multilayered, analytical element coated on a polyester support.
layer contains surfactants; N-acetylcysteine (NAC), which activates CK without pretreatment of the sample; and goat
antihuman CK-M antibodies, which inhibit CK-MM (muscle) activity and ~50% of the CK-MB (heart) activity. The remaining
CK activity represents 50% of the total CK-MB isoenzyme concentration plus any-CK-BB (relatively rare).
In the reagent layer, creatine kinase in the sample catalyzes the conversion of creatine phosphate and adenosine
diphosphate (ADP) to creatine and adenosine triphosphate (ATP). In the presence of glycerol kinase, glycerol is
phosphorylated to L-a-glycerophosphate which is then oxidized to dihydroxyacetone phosphate and H2O2 in the reaction
catalyzed by L-a-glycerophosphate oxidase. Finally, leuco dye is oxidized by hydrogen peroxide in the presence of peroxidase
to form a dye.
The low wavelength light cutoff filter on the slide support minimizes the blank rate effects of incident light during dye
development.
The rate of change in reflection density is converted to enzyme activity.
Reaction Sequence
anti CK-M antibody
CK-MM + CK-MB
creatine phosphate + ADP
->•
creatine kinase-B
NAC,
->•
creatine + ATP
L-a-glycerophosphate oxidase
peroxidase
H2O2 + leuco dye
->•
Mg
glycerol kinase
glycerol + ATP
CK-M inhibition
dihydroxyacetone phosphate + H2O2
dye + 2H2O
Test Type and Conditions for CKMB DT
Test Type
Rate
Version 1.0
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Pub. No. C-351
Temperature
37°C (98.6°F)
Wavelength
680 nm
Sample Drop
Volume
10 uL
CKMBDT
Creatine Kinase MB
Reagents
Slide Diagram
Slide Ingredients
t
"
2
/ %
L-a-glycerophosphate oxidase (Aerococcus viridans, E.C.1.1.3.21) 0.39 U;
peroxidase (horseradish root, E.C.1.11.1,7) 1.4 U; glycerol kinase (£. coli or
Cellulomonas sp, E.C.2.7.1.30) 0.45 U; creatine phosphate 0.17 mg;
N-acetylcysteine 43 ug; goat anti-human CK-M antibody 0.25 mg; magnesium
acetate 68 ug; glycerol 23 ug; 2-(3,5-dimethoxy-4-hydroxyphenyl)
-4,5-bis(4-dimethylaminophenyl) imidazole (leuco dye) 20 ug; and adenosine
diphosphate 8.4 ug.
7^7-— - 4
~"^~--^
-
5
"•
Other ingredients
Pigment, binder, buffers, surfactants, inhibitors, stabilizers, cross-linking
agent, dye solubilizer, filter dyes, scavenger and chelator.
1 . Upper slide m o u n t
2 . S p r e a d i n g layer (TIO2)
• N-acetylcysteine
• goat antihuman CK-M
antibody
Reagent layer
• adenosine diphosphate
• Mg acetate
leuco dye
* glycerol kinase
peroxidase
L-a-glycerophosphate
oxidase
creatine phosphate
glycerol
buffer, pH 7.0
4. Support layer
6. Filter
• low wavelength light cutoff
filter
Slide Handling
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18 - 2 8 °C (64 °-82 °F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1. Remove the unopened slide from the box.
2. Warm the unopened slide for 15 minutes. Unopened slides that remain in the sealed wrapper may be returned to
VITROS CKMB DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CKMB DT
Slides
Storage Condition
Unopened
Opened
Room temperature
Frozen
Room temperature
18°-28°C (64°-82°F)
<-18QC (<0°F)
18°-28°C (64°-82°F)
Pub. No. C-351
Stability
<48 hours
<15 minutes
Version 1.0
Q VITRtpS
CKMBDT
Creatine Kinase MB
• Serum
IMPORTANT;
•
Plasma:
EDTA
Heparin
Serum
Patient Preparation
Special Precautions
• Centrifuge specimens and remove the serum from the cellular material within 4 hours of collection.6
WARNING:
•
•
Specimen Storage and Stability for CKMB DT: Serum6
Temperature
Storage
Room temperature
18°-28°C(64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
Stability
<4 hours
<2 days
<1 year
Testing Procedure
Materials Provided
•
VITROS Chemistry Products CKMB DT Slides
•
•
•
•
•
VITROS Chemistry Products DT Isoenzyme Calibrator Kit
Quality control materials, such as VITROS Chemistry Products DT Isoenzyme Control I
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If Creatine Kinase MB concentrations exceed the system's reportable (dynamic) range:
1. Dilute the sample with VITROS 7% BSA or reagent-grade water.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's creatine kinase MB activity.
Version 1.0
Pub. No. C-351
GKMBDT
Creatine Kinase MB
Calibration
Calibration
VITROS Chemistry Products DT Isoenzyme Calibrator Kit
Refer to the instructions for use for VITROS DT Isoenzyme Calibrator Kit.
When to Calibrate
Calibrate:
The VITROS CKMB DT test may also need to be calibrated:
Calculations
I
activity. Once a calibration has been performed for each slide lot, creatine kinase activity in unknown samples can be
a calibration.
Reportable (Dynamic) Range for CKMB DT
1.0-300.0
I
Values assigned to the VITROS Chemistry Products DT Isoenzyme Calibrator Kit for creatine kinase MB isoenzyme (CK-MB)
are traceable to a CK-M immunoinhibition method with quantitation of the remaining CK-B subunit activity by a modification of
the Scandinavian Committee on Enzymes 78 recommended method for the determination of creatine kinase activity at 37°C.
Quality Control
|
WARNING:
•
•
•
•
Handle quality control materials as blohazardous material.
System.
Pub.
No. C-351
Version 1.0
CKMRDT
Interpretation of Results and Expected Results
•
•
Creatine Kinase MB
IIPORWT:
•
•
•
I
VITROS DT Isoenzyme Control I is recommended for use with the VITROS
DT60/DT60 II Chemistry System. Evaluate the performance of other commercial
control fluids for compatibility with this test before using for quality control.
Control materials other than VITROS DT Isoenzyme Control I may show a difference when compared with other creatine
kinase MB methods if they:
Refer to the instructions for use for VITROS Chemistry Products DT Isoenzyme Control I or to other manufacturer's product
literature.
Interpretation of Results
Elevated CK-MB activities are a sensitive and specific indicator of myocardial infarction (Ml). The diagnosis of myocardial
infarction should not be based solely on CK-MB results but should be supported by other clinical and laboratory
parameters. Clinical judgment is required to interpret CK-MB results.
Judgments based on single determinations are of limited value because the CK-MB peak is of short duration. As with any
CK-MB method, if the sample is obtained significantly before or after the peak, the result may be negative. Most clinical studies
have recommended that samples be taken every 8 to 12 hours.
CK-MB results are usually considered positive when three criteria are met:
1. A significant level of CK-MB activity must be present. A decision value of 16 U/L is recommended.10 Values of less than
16 U/L should be reported as negative for CK-MB and % CK-MB should not be calculated.
2. The CK-MB results should fall between 4% and 25% of the total CK value. If % CK-MB is outside this range, the elevation
may have arisen from factors other than myocardial infarction.
% CK-MB = CK-MB x 100
CK
For example:
.
CK-MB < 4%.
Skeletal muscle contains some CK-MB and significant skeletal muscle damage can result in elevated CK-MB activity. The
percentage of CK-MB in muscle is low, however, and CK-MB as a percentage of total CK may remain normal (<4%).
• CK-MB > 25%.
The slide results are actually a measure of the B subunit of CK-MB; therefore, the presence of CK-BB or macro CK type I
or type II can cause up to twice the measured CK-MB result that would be expected based on total CK activity. Results
greater than 25% may indicate presence of CK-BB or macro CK type I or type II. These results should be confirmed by an
alternate method.
3. The rise in CK-MB activity to a peak approximately 18 hours after the infarction and the subsequent fall in activity is
characteristic of myocardial infarction. CK variants are relatively stable in circulation and do not show the rise-and-fall
pattern.
The suggested decision criteria for diagnosis of myocardial infarction have been provided by Dr. T. C. Kwong.10 These criteria
are based on a study of 134 patients consecutively admitted to the coronary care unit of the University of Rochester Medical
Center in Rochester, New York. Each laboratory should confirm the validity of this protocol for the population it serves.
Criteria were chosen to maximize the diagnostic efficiency of the test where:
Diagnostic Efficiency (%) = True Positives + True Negatives x 100
Total Patients
Decision criteria may vary from laboratory to laboratory depending on age, sex, diet, and racial composition of the population,
as well as the prevalence of myocardial infarction. Decision criteria may be adjusted to favor either a positive predictive value
or a negative predictive value, depending on the intended use of the assay. The table below shows how different cutoff values
for peak CK-MB affects the sensitivity and specificity of the test, compared with an electrophoretic procedure. Use the flowchart
in figure 1 as a quick reference guide.
Version 1.0
Pub. No. C-351
5
VITRCpB El
CKMB DT
Creatine Kinase MB
An alternative use of the test is to screen samples from patients with possible myocardial infarction and to confirm positive
results by an alternative method. A total CK value within the normal range is not a reliable index to exclude analysis of
CK-MB.11
Effects on Sensitivity and Specificity of Various Cutoff Values for Peak CK-MB
CK-MB Cutoff (U/L)
10
12
14
16
18
20
22
24
Specificity (%)
79
89
93
94
95
96
96
98
Sensitivity (%)
96
96
93
91
85
82
78
78
Efficiency (%)
86
92
93
93
91
90
89
90
The VITROS Chemistry System may be programmed to report CK-MB results in conventional, SI, and alternate units.
Reporting Units and Unit Conversion for CKMB DT
U/L
Figure 1. Interpretation of Results: Quick Reference Guide
r alternative diagnoses
Yes
Perform serial CK-MB assays
Proper mserpretatjtm af CK-MB results reqyeres
serial determinations in all circumstances
"Normal" Total CK is not 8 reliable index to
exclude CK-MB determ
'
<
--,,
% MB at ieasf 4%?
.^•>
-5!
Negative tor CK-MB
•
IHtjh U/L M8 liul low ~o MB
syo^ftsts skoictiil muscle damage)
{
Ntgativft foi CK-Mfl
""\
l
"~"\
{%, MB greater than 25%
suggests macro CK ar CK-BBI
<T
%MBI6SS«KHS2S%?
J ^ "
t
Yes
<C
Resiilts siintiki 1H> confimuHt by an
alter native method arid «v3luat*)d tJ$i!i(j
other cSinicfil and laisorator^'parameters
,
* •
Rise-and-fall pattern?
~^>-
Pub.
So
^
f
NegativetorCK-MB
^
(Consistent but elevated CK-MB
may be atypical macro or BB1
No. C-351
"\
/
Version 1.0
CKMB DT
Creatine Kinase MB
Know.n Interferences
CK-BB (present in neonates,12 brain ischemia, cerebellar hematoma, shock,13 and carcinomas14) and macro CK type I and
type II falsely elevate CK-MB results. These can be differentiated from true CK-MB by the lack of the characteristic CK-MB
time pattern. Refer to "Interpretation of Results."
• Total CK activity greater than 1000 U/L may result in falsely elevated CK-MB results. Samples with TCK >1000 U/L should
be diluted prior to analysis.
The VITROS CKMB DT Slide method was screened for interfering substances following NCCLS Protocol EP7.16 The
•
Known Interfering Substances for CKMB DT
3mg/dL
(170 umol/L)
Creatine Kinase
Activity
Conv./SI Units (U/L)
40
835mg/dL
(13.1 mmol/L)
40
-12
6mg/dL
(180 Mmol/L)
48
-4.3
Interferent
Concentration
Interferent*
Ascorbic acid
Diatrizoate sodium
(Hypaque)
Dipyrone
Average Bias
-6
It is possible that other interfering substances may be encountered. These results are representative; however, your
results may differ somewhat due to test-to-test variation. The degree of interference at concentrations other than
those listed might not be predictable.
Other Limitations
Certain drugs and clinical conditions are known to alter creatine kinase MB activity in vivo. For additional information, refer to
one of the published summaries.16 17 18
Method Comparison
using the Immunoinhibition comparative method with quantitation of the remaining CK-B subunit activity by a modification of the
Scandinavian Committee on Enzymes.7 8 Testing followed NCCLS Protocol EP9.19
Method Comparison for CKMB DT: Serum
y =x
."mi
25ii
200
ISO
too
50
0
10
100
150
300
250
300
350
Comparative Method: Immunoinhibition
(U/L)
Version 1.0
Pub. No. C-351
CKMBDT
Creatine Kinase MB
References
Method Comparison for CKMB DT: Serum
Correlation
Range of
Slope Coefficient Sample Activity Intercept
n
DT60 II System vs.
comparative method
77
1.00
0.999
2-292
0.41
Sy.x
4.32
Precision
Precision for CKMB DT: Serum
System
VITROS DT60 II
Mean Activity
Within Day SD*
Within Lab SD**
Within Lab CV%**
No. Observ.
No. Days
11
0.3
0.6
5.5
88
22
29
0.6
1.0
3.5
88
22
References
1.
2.
3. Calam RR. Specimen Processing Separator Gels: An Update. J Clin Immunoassay. 11:86-90; 1988.
4.
1991.
5. NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS;
1991.
7. Scandinavian Committee on Enzymes: Recommended Method for the Determination of Creatine Kinase in Blood. Scand. J. Clin. Lab.
Invest. 36:711-723; 1976.
8. Scandinavian Committee on Enzymes: Recommended Method for the Determination of Creatine Kinase in Blood. Scand. J. Clin. Lab.
Invest. 39:1-5; 1979.
10. Kwong TC. Studies conducted at the University of Rochester Medical Center, Rochester, New York; 1986.
11. Yusuf S, et al. Significance of Elevated MB Isoenzyme with Normal Creatine Kinase in Acute Myocardial Infarction. Am. J. Cardiol.
59:245; 1989.
12. Jedukin R, et al. Creatine Kinase Isoenzymes in Serum from Cord Blood and the Blood of Healthy Full-Term Infants during the First
Three Postnatal Days. Clin. Chem. 28:2; 1982.
13. Gerhardt W, et al. Creatine Kinase and Creatine Kinase B-Subunit Activity in Serum Cases of Suspected Myocardial Infarction. Clin.
Chem. 28:2; 1982.
14. Stein W, et al. Macro Creatine Kinase Type 2: Results of a Prospective Study in Hospitalized Patients. Clin. Chem. 31:12; 1985.
18. Tryding N, Tufvesson C, Sonntag O (eds). Drug Effects in Clinical Chemistry, ed. 7. Stockholm: The National Corporation of Swedish
Pharmacies, Pharmasoft AB, Swedish Society for Clinical Chemistry; 1996.
NCCLS; 1995.
1992.
Pub. No. C-351
Version 1.0
CKMBDT
Glossary of Symbols
Creatine Kinase MB
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Keep Dry
Store At or Below
This end up
A M
OlN
Number
X
Catalog Number or
Product Code
X
Attention: See
Store At or Above
Revision History
Date of
Revision
2003-04-30
Version
. 10
New format
Specimens Not Recommended - removed fluoride oxalate
Sample Dilution - added VITROS 7% BSA; deleted isotonic saline
• Limitations of the Procedure - updated values for Dipyrone in the Known
Interfering Substances table
• References - added 1 , 2 , 3 , 4 , 5 , 6 , 9 , 15,18, 19,20
•
•
•
•
•
Signature
Version 1.0
Obsolete Date
Pub. No. C-351
CKMBDT
Revision History
Creatine Kinase MB
C€
EC
Mandeville House
62 The Broadway
Amersham
England
8 ôtuwoHêfwHum company
10
Pub.
No. C-351
Version 1.0
(Products;
VITRIIIS
Chemistry!
Cl DT
VITROS Chemistry Products CI" DT Slides
Chloride
Intended Use
VITROS Cl" DT Slides quantitatively measure chloride (Cl) concentration in serum and plasma.
Chloride is the major anion in the extracellular water space; its physiological significance is in maintaining proper body water
distribution, osmotic pressure, and normal anion-cation balance in the extracellular fluid compartment. Chloride is increased in
dehydration, in renal tubular acidosis (hyperchloremia metabolic acidosis), and in excessive infusion of isotonic saline. Chloride
is decreased in overhydration, chronic respiratory acidosis, salt-losing nephritis, metabolic alkalosis, and congestive heart
failure.1
The VITROS Cl" DT Slide method is performed using the VITROS Cl" DT Slide and the VITROS Chemistry Products
The VITROS Cl" DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry2 for
measurement of chloride ions. The slide consists of two ion-selective electrodes, each containing a protective layer, a silver
layer and a silver chloride layer coated on a polyester support. The protective layer inhibits interference from normal levels of
bromide and uric acid.
A drop of patient sample and a drop of VITROS DT Reference Fluid on separate halves of the slide results in migration of both
fluids toward the center of the paper bridge. A stable liquid junction is formed connecting the reference electrode to the sample
indicator electrode.
Each electrode produces an electrical potential in response to the activity of chloride ions applied to it. The potential difference
poised between the two electrodes is proportional to the chloride concentration in the sample.
Test Type and Conditions for Cl DT
Test Type
Potentiometric
VITROS DT60/DT60 II
Module
Approximate Incubation Time
DTE/DTE II
180 seconds
Temperature
25°C (77°F)
Drop Volume
Sample:
Reference
Fluid: 10 uL
10 ML
Version 1.0
Pub. No. C-309
Cl DT
Reagents
Chloride
Reagents
Slide Diagram
Slide Ingredients
1.
2.
3.
4.
Upper frame
Paper bridge
Protective layer
Sliver, silver chloride
layer
6. Support layer
6. Lower frame
Silver 0.4 mg; and silver chloride 0.2 mg.
Other ingredients
Polymer, plasticizer, surfactant and nickel.
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
opened.
(64°-82°F) for >48 hours.
1.
2.
VITROS CT DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for Cl DT
Slides
Unopened
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18O-28°C (64°-82°F)
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
I
Serum
Plasma:
IMPORTANT:
Heparin
Patient Preparation
Special Precautions
• Do not draw specimen from an arm receiving an intravenous transfusion.
• Fibrin clots may cause incomplete sampling of the specimen.7
- Allow specimens to clot completely in order to prevent fibrin clots.
- Inspect plasma specimens for the presence of fibrin clots.
e Centrifuge specimens and remove the serum from the cellular material within 4 hours of collection.'
Pub.
No. C-309
Version 1.0
Cl DT
Testing Procedure
Chloride
•
•
Specimen Storage and Stability for Cl DT; Serum and Plasma8
Temperature
Stability
Storage
18°-28°C(64°-82°F)
Room temperature
<7 days
Refrigerated
2°-8°C (36°-46°F)
<4 weeks
Indefinite
Frozen
<-18°C (<0°F)
Testing Procedure
Materials Provided
•
VITROS Chemistry Products Cl" DT Slides
•
•
•
•
•
VITROS Chemistry Products DT Reference Fluid
VITROS DTE Dual Sample Cups
VITROS DTE Pipette
•
I
MPORTANT:
analysis.
Sample Dilution
Chloride concentrations outside the reportable (dynamic) range are not expected. Diluted samples should not be analyzed with
VITROS Cl" DT Slides because dilution changes both the concentration of solids in plasma water and the ionic strength of the
sample.
Calibration
VITROS Chemistry Products DT Calibrator Kit, bottles 1 and 2
NOTE:
Calibrate choloride in duplicate by running each bottle twice.
When to Calibrate
Calibrate:
• When the VITROS DT Reference Fluid lot number changes.
The VITROS Cl" DT test may also need to be calibrated:
Version 1.0
Pub. No. C-309
3
Cl DT
Chloride
Quality Control
Calculations
The VITROS DT60/DT60 II Chemistry System measures the potential difference in millivolts between the two electrodes of a
potentiometric slide—one in contact with the sample to be analyzed and the other in contact with the electrolyte reference fluid.
A linear relationship exists between the measured potential difference observed on the slide and the logarithm of chloride
concentration, i.e. the Nernst equation for ion-selective electrodes. Once the calibration has been established for each slide lot,
unknown chloride concentrations for a given sample can be determined using the software-resident math model and the
measured potential difference.
Calibration parameters are automatically assessed by the VITROS DT60/DT60II Chemistry System against a set of quality
a calibration.
Reportable (Dynamic) Range for CI" DT
Conventional and SI Units (mmol/L)
65-140
I
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for chloride are traceable to the Certified NIST (National
Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 919a. The Ortho-Clinical
Diagnostics calibration laboratory uses SRM® 919a to calibrate the coulometric-amperometric titration method9'10 to support
chloride value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
."">,.
•
•
•
System.
•
•
and Definitions; Approved Guideline-Second Edition'1'1 or other published guidelines.
•
I
IMPORTANT;
•
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other chloride methods
if they:
Pub. No. C-309
Version 1.0
CIDT
Chloride
Reference Interval
This reference interval is the central 95% of results from an internal study of 60 apparently healthy individuals from a working
population.
Reference Interval for CI" DT
98-107
Adult
The VITROS DT60/DT60 II Chemistry System may be programmed to report chloride results in conventional and SI units.
Reporting Units for CI" DT
mmol/L
Known Interferences
Bromide and iodide from therapeutic drugs and ointments may cause a bias of approximately 3 mmol/L and 4 mmol/L,
respectively, for each mmol of halide. Normal physiological levels of bromide and iodide do not interfere.
Other Limitations
Certain drugs and clinical conditions are known to alter chloride concentration in vivo. For additional information, refer to one of
the published summaries.1213
Method Comparison
I
Method Comparison for CI DT: Serum
175
y=x
1 50 •
125
100
75 •
SO
75
100
125
150
175
Comparative Method: VITROS 950
(mmol/L)
Version 1.0
Pub. No. C-309
Cl DT
Chloride
References
Method Comparison for Cl' DT: Serum
DT60 II System vs.
comparative method
n
Slope
Intercept
Sy.x
51
0.96
0.995
75-132
5.67
1.24
Precision
Precision for Cl DT: Serum
System
VITROS DT60 II
Mean Cone.
Within Day SD*
Within Lab SD**
Within Lab CV%**
No. Observ.
No. Days
78
0.2
0.8
1.1
88
22
100
0.4
1.2
1.2
88
22
References
1.
2.
3.
Siggard-Anderson O. Electrochemistry, in Tietz NW (ed). Textbook of Clinical Chemistry. Philadelphia: WB Saunders; 110-125; 1986.
4.
5. NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS;
1991.
1991.
7. Slockbower JM, Blumenfeld TA (ed.). Collection and Handling of Laboratory Specimens. Philadelphia: Lippincott Co; 201; 1983.
9. Dietz AA, Bond EE, Chloride, Coulomeric-amperometric Methods, in: Faulkner WR, Meites S, eds. Selected Methods of Clinical
Chemistry, Washington: American Association for Clinical Chemistry. 9:149-152.; 1982.
10. Velapoldi RA, Paule RC, Schaffer R, Mandel TJ, Gramlich JW. Standard reference materials: A reference method for the determination
of chloride in serum. National Institute of Standards and Technology Special Publication 260-67. Washington, D.C.; 1979.
NCCLS; 1995.
1992.
Pub. No. C-309
Version 1.0
CIDT
Glossary of Symbols
Chloride
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Date (YYYY-MM-DD)
Lot Number
Tests
Number
"RIFI
Catalog Number or
Product Code
Store At or Below
A
Attention: See
2
SN
i
X
I
t
Store Between
Use
Care.
Keep Dry
This end up
Store At or Above
Revision History
Date of
Revision
2003-10-01
Version
1.0
New format
Specimens Recommended - updated wording
Quality Control Material Selection - added the statement regarding ethylene
glycol
•
•
•
•
•
Obsolete Date
Signature
Version 1.0
Pub. No. C-309
VITRIJ35 0
CIDT
Revision History
Chloride
C€
EC
I REP
Mandeville House
62 The Broadway
Amersham
England
ê&tMroH company
Pub. No. C-309
Version 1.0
Products
VITRCD5
Chemistry!
CO2DT
VITROS Chemistry Products CO2 DT Slides
Carbon Dioxide
Intended Use
VITROS CO2 DT Slides quantitatively measure carbon dioxide (CO2) concentration in serum and plasma.
Total carbon dioxide measurements are used together with other clinical and laboratory information (pH, pCO2) for the
evaluation of acid-base status.
The VITROS CO2 DT Slide method is performed using the VITROS CO2 DT Slides and the VITROS Chemistry Products
The VITROS CO2 DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry
for measurement of ionic carbon dioxide.
The slide consists of two ion-selective electrodes, each containing a buffer layer, an ion selective membrane layer, a reference
layer, and a silver and a silver chloride layer coated on a polyester support.
The buffer layer adjusts the sample pH to 8.4 and maintains CO2, HCO3", and CO3"2 in proper equilibrium. The ion-selective
membrane layer contains an ion exchanger trioctylpropylammonium chloride (TOPA Cl) and a CO3'2 ionophore
decyltrifluoroacetophenone(DTFA).
Each electrode produces an electrical potential in response to the concentration of carbon dioxide applied to it. The potential
difference poised between the two electrodes is proportional to the carbon dioxide concentration in the sample.
Test Type and Conditions for CO2 DT
Test Type
Potentiometric
VITROS DT60/DT60 II
Module
DTE/DTE II
3 minutes
Temperature
25°C (77°F)
Drop Volume
Sample:
Reference
10 ML
Fluid: 10 |JL
Version 1.0
Pub.
No. C-308
CO2DT
Carbon Dioxide
Reagents
Reagents
Slide Diagram
Slide Ingredients
2
Silver 0.4 mg; silver chloride 0.2 mg; sodium chloride 0.2 mg; potassium
chloride 63 ng; trioctylpropylammonium chloride 0.3 mg; and
decyltrifluoroacetophenone 0.8 mg.
-
9
* • - .
Other ingredients
b
Binders, plasticizers, surfactants, stabilizer, buffers and nickel.
G
T
1. Upper frame
2. Paper Bridge
3. Ion-selective
membrane
• TOPA Cl
• DTFA
4. Reference layer
• KCI
• NaCI
6. Silver, sliver chloride
layer
6. Support layer
7. Lower frame
Slide Handling
Slide Preparation
The slide must reach room temperature, 18°-28°C (64°-82f),
opened.
before the wrapper is
(64°-82°F) for >48 hours.
1.
2.
VITROS CO2 DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CO2 DT
Storage Condition
18°-28°C (64°-82°F)
Room temperature
Refrigerated
2°-8 c C (36°-46°F)
Frozen
<-18°C (<0°F)
18O-28°C(64°-82°F)
Room temperature
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
Serum
Plasma:2
Heparin
IMPORTANT:
Serum and Plasma
NOTE:
For details on minimum fill volume requirements, refer to the operator's manual for
your VITROS Chemistry System.
Patient Preparation
Pub. No. C-308
Version 1.0
Q
VITR^S
CO2DT
Carbon Dioxide
Testing Procedure
Special Precautions
• Do not use specimens from patients receiving radiographic contrast agents containing diatriazoate sodium. Refer to
"Limitations of the Procedure."
• Every effort should be made to fill vacuum tubes completely when collecting blood because a decrease of up to 3 mmol/L
can be observed with partially filled tubes.6
- Inspect plasma specimens for fibrin clots.
Storage
•
•
Specimen Storage and Stability for CO2 DT: Serum and Plasma8
Storage
Room temperature, tightly capped
Refrigerated
Frozen
Temperature
18 0 -28 0 C(64 0 -82 0 F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<24 hours
<3 days
<1 month
Testing Procedure
Materials Provided
•
VITROS Chemistry Products CO2 DT Slides
•
•
•
•
•
VITROS DTE Pipette
•
IMPORTANT:
analysis.
Sample Dilution
Carbon dioxide concentrations outside the reportable (dynamic) range are not expected. Diluted samples should not be
analyzed with VITROS CO2 DT Slides.
Calibration
Special Precautions
Calibrate CO2 in duplicate by running each calibrator bottle twice.
Version 1.0
Pub. No. C-308
VITQI
C0 2 DT
Carbon Dioxide
Quality Control
When to Calibrate
Calibrate:
The VITROS CO2 DT test may also need to be calibrated:
Calculations
A linear relationship exists between the measured potential difference observed on the slide and the logarithm of carbon
dioxide concentration, i.e. the Nernst equation for ion-selective electrodes. Once the calibration has been established for each
slide lot, unknown carbon dioxide concentrations for a given sample can be determined using the software-resident math model
and the measured potential difference.
a calibration.
Reportable (Dynamic) Range for CO; DT
5-50
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for carbon dioxide are traceable to the Certified
NIST (National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 192b. The
Ortho-Clinical Diagnostics calibration laboratory uses SRM®192b to calibrate the Corning Model 965 analyzer,9 lc utilizing
thermal conductivity detection, to measure total carbon dioxide in support of carbon dioxide value assignment for the
VITROS Chemistry Products DT Calibrator Kit.
Quality Control
I
WARNING;
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition^ or other published guidelines.
Pub. No. C-308
Version 1.0
|*J VITRI
COzDT
Carbon Dioxide
IMPORTANT:
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other Carbon Dioxide
methods if they:
Reference Interval
This reference interval is the central 95% of results from a study of 60 apparently healthy adults from a working population
(34 females and 26 males).
Reference Interval for CO? DT
22-30
The VITROS DT60/DT60 II Chemistry System may be programmed to report carbon dioxide results in conventional and SI
units.
Reporting Units for CO, DT
mmol/L
Known Interferences
•
Lactate, hippurate, and other organic acids at significantly elevated concentrations have been reported to increase CO2
results.12
• Diatrizoate sodium may increase CO2 results. Do not use specimens from patients receiving radiographic contrast agents
containing this substance.
The VITROS CO2 Slide method was screened for interfering substances following NCCLS Protocol EP7.13 The substances
Known Interfering Substances for CO2 DT
Interferent*
Bromide
Iodide
Nitrate
Interferent Concentration
Conv./SI Units (mmol/L)
2
1
3
Carbon Dioxide Cone.
25
25
25
Average Bias
2
4
11
It is possible that other interfering substances may be encountered. These results are representative; however, your
results may differ somewhat due to test-to-test variation. The degree of interference at concentrations other than those
listed might not be predictable.
Version 1.0
Pub. No. C-308
COzDT
Carbon Dioxide
Other Limitations
Certain drugs and clinical conditions are known to alter total carbon dioxide concentration in vivo. For additional information,
Method Comparison
I
Method Comparison for CO2 DT: Serum
y =x
40 1
I
30 1
20
10
20
30
40
(mmol/L)
Method Comparison for CO2 DT: Serum
(mmol/L)
DT60 II System vs.
950 System
n
Slope
Correlation
Coefficient
Range of
Sample Cone.
82
0.92
0.990
13-38
Intercept Sy.x
2.13
0.82
Precision
Precision for CO2 DT: Serum
System
VITROS DT60 II
Mean Cone .
24
18
*
**
Within Day SD* Within Lab SD** Within Lab CV%**
0.6
0.5
No. Observ.
No. Days
0.7
3.1
88
22
0.6
3.2
88
22
Pub. No. C-308
Version 1.0
CO2DT
References
Carbon Dioxide
References
1.
2.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA:. NCCLS;
1991.
1991.
12.
13.
14.
15.
16.
HerrRD, Swanson T. Serum Bicarbonate Declines With Sample Size In Vacutainer Tubes. AJCP. 97:213-216; 1992.
Slockbower JM, Blumenfeld TA (ed.). Collection and Handling of Laboratory Specimens. Philadelphia: Lippincott Co; 201; 1983.
Van Slyke D C , Neil! J.M. J. Biol. Chem., 1924; 61: 523-526.
Corning 965 Carbon Dioxide Analyzer Instruction Manual, Corning Medical, Medfield, MA., 1977.
17.
9.
10,
11.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Version 1.0
Date (YYYY-MM-DD)
EC
Lot Number
V
REP I
Manufacturer
Store Between
Use
Tests
Care.
SN
Number
Keep Dry
REF
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Pub. No. C-308
C02DT
Carbon Dioxide
Revision History
Revision History
Date of
Revision
2003-08-11
Version
1.0
• New format
> Specimen Storage and Stability - updated stability
> Reference Interval - updated data
» Limitations of the Procedure - added carbon dioxide concentration and bias for
known interfering substances; removed the note
• Method Comparison - updated the data and plot
« References - added all
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
company
Pub. No. C-308
Version 1.0
VITRCDS
Chemistry!
CREAOT
VITROS Chemistry Products CREA DT Slides
Creatinine
Intended Use
VITROS CREA DT Slides quantitatively measure creatinine (CREA) concentration in serum and plasma.
Serum creatinine excretion is a function of lean body mass in normal persons and shows little or no response to dietary
changes. The serum creatinine concentration is higher in men than in women.
Serum creatinine is increased in acute or chronic renal failure, urinary tract obstruction, reduced renal blood flow, shock,
dehydration, and rhabdomyolysis. Causes of low serum creatinine concentration include debilitation and decreased muscle
mass. Exercise may cause an increased creatinine clearance.
The VITROS CREA DT Slide method is performed using the VITROS CREA DT Slide, the VITROS NH3 DT Slide, and the
VITROS Chemistry Products DT Calibrator Kit on VITROS DT60/DT60 II Chemistry Systems.
Refer to the VITROS NH3 DT Instructions for Use for an explanation of the principles of the procedure.
The VITROS CREA DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the VITROS CREA DT Slide. The specimen is evenly distributed by the spreading
layer to the underlying layers. Water and nonproteinaceous components travel to the underlying buffered reagent layer.
Creatinine iminohydrolase catalyzes the hydrolysis of creatinine to produce ammonia. Both the ammonia produced in the
previous reaction and endogenous ammonia from the sample diffuse through the semipermeable membrane to react with an
ammonia indicator to produce a blue dye.
After a fixed incubation time, the reflection density is proportional to the concentration of creatinine and endogenous ammonia
in the sample. The software resident in the VITROS DT60/DT60 II System calculates a final creatinine concentration by
subtracting the endogenous ammonia concentration measured by the VITROS NH3 DT Slide from the creatinine and
endogenous ammonia concentration measured by the VITROS CREA DT Slide.
Reaction Sequence
creatinine iminohydrolase
creatinine + H2O
N-methylhydantoin + NH3
NH3 + bromphenol blue (ammonia indicator)
blue dye
Test Type and Conditions for CREA DT
Test Type
Colorimetric
Version 1.0
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Pub. No. C-334
Temperature
37°C (98.6°F).
Wavelength
605 nm
Sample Drop
Volume
10 ML
CREADT
Creatinine
solid and liquid waste, and test components in accordance with local regulations and NCCLS Guideline M29' or other
Reagents
Slide Diagram
Slide Ingredients
2
Creatinine iminohydrolas'e (Bacillus species, EC.3.5.4.21) 0.5 U and
bromphenol blue 27 ng.
'*°
y
/,'' *
' ^'
• 4
Other ingredients
;
w
" ~"
— £
Pigment, binders, surfactants, buffer and stabilizer.
, — - -— ' " "
2. Spreading layer (T1O2)
3. Reagent layer
• creatinine iminohydrojase
• buffer. pH 9.3
4. Semtpermeable
membrane
6. indicator layer
• bromphenol blue
6. Support layer
r
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT;
The slide must reach room temperature, 18 "-28 °C (64 °~82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 1 8 - 2 8 "C
(64 "-82 °F) for >48 hours.
1.
2.
VITROS CREA DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CREA DT
Slides
Unopened
Storage Condition
Room temperature
18°-28 C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28 'C (64°-82° F)
Opened
Stability
<48 hours
<4 weeks
<15 minutes
WARMING:
•
•
Serum
Plasma:2
IMPORTANT:
EDTA
Heparin (except ammonium heparin)
Pub. No. C-334
Version 1.0
INSTRUCTIONS FOR USI
CREADT
Creatinine
Testing Procedure
Serum and Plasma
Patient Preparation
•
Special Precautions
NOTE:
•
Avoid using ammonia-containing cleaning solutions or hand creams in the area
around the analyzer.
Centrifuge specimens and remove the serum from the cellular material within 15 minutes of collection.2
•
•
•
Two slides are used in the analysis of creatinine (the VITROS CREA DT Slide and the VITROS NH3 DT Slide). The
VITROS NH3 DT Slide provides a blank correction value for normal concentrations of ammonia present in serum.
Therefore, it is important to minimize the formation of ammonia during specimen storage.
Specimen Storage and Stability for CREA DT: Serum and Plasma2
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
Stability
not recommended
<3 hours
<24 hours
Testing Procedure
Materials Provided
.
VITROS Chemistry Products CREA DT Slides
.
.
•
.
.
VITROS Chemistry Products NH3 DT Slides
VITROS 7% BSA or reagent-grade water
VITROS DT Pipette
•
NOTE:
The VITROS NH3 DT Slide provides a blank correction value for normal
concentrations of ammonia present in serum. The VITROS CREA DT Slide must be
run first, followed by the VITROS NH3 DT Slide. The analyzer displays "INSERT NH3
SLIDE." When VITROS CREA DT or VITROS NH3 DT Slides are present in the
incubator, the analyzer displays "ANALYZER READY-CREA/NH3 ONLY." No tests can
be run until the CREA/NH3 results are complete.
IMPORTANT:
Bring all fluids and samples to room temperature, 18°-28°C (64°-82°F); analyze
immediately.
Sample Dilution
If creatinine concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the result by the dilution factor to obtain an estimate of the original sample's creatinine concentration.
Version 1.0
Pub. No. C-334
CREA DT
Creatinine
Calibration
Calibration
VITROS Chemistry Products DT Calibrator Kit, bottles 1, 2, 3, and 4
NOTE:
To avoid ammonia formation, calibrator fluids should be prepared only when ready to
calibrate and should be run within 1 hour after preparation.
NOTE:
Because ammonia is produced in the VITROS BUN/UREA DT Slide reaction, the
analyzer will display a warning message "ANALYER READY—NO CREA/NH3" during
calibration of VITROS BUN/UREA DT Slides. Therefore, it is recommended that
creatinine and ammonia be the first tests calibrated after the preparation of calibrator
fluids.
When to Calibrate
NOTE:
The VITROS CREA DT test is dependent on correct calibration of the VITROS NH3 DT
Slides used as blanks. Therefore, the VITROS NH3 DT Slides must be calibrated
whenever VITROS CREA DT Slides are calibrated.
Calibrate:
The VITROS CREA DT test may also need to be calibrated:
Calculations
Because the VITROS CREA DT Slide measures both creatinine and endogenous ammonia, the VITROS CREA DT Slide
response is proportional to the concentration of both substances in the sample. A second slide, reactive only to ammonia, is
sequentially measured for the blank correction of the VITROS CREA DT Slide response. Reflectance from both slides is
measured at 605 nm after the fixed incubation time. Calibration using the blank-corrected calibration model consists of two
parts—calibration of the VITROS NH3 DT Slide (blank), followed by calibration of the VITROS CREA DT Slide. Once a
calibration has been performed for each slide lot of VITROS NH3 DT Slides and VITROS CREA DT Slides, creatinine
concentration in unknown samples can be determined using the software-resident endpoint colorimetric, blank-corrected math
model and the responses obtained from both the VITROS CREA DT and VITROS NH3 DT Slides.
a calibration.
Reportable (Dynamic) Range for CREA DT
0.01-15.0
SI Units <umol/L)
1-1326
Pub.
No. C-334
Version 1.0
CREA DT
Quality Control
Creatinine
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for creatinine are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM* (Standard Reference Material) 914a. The
Ortho-Clinical Diagnostics calibration laboratory, uses SRM® 914a to calibrate selected measurement procedures, including an
HPLC (High Performance Liquid Chromatography)6 method and a rate Jaffe' method, to support creatinine value assignment
for the VITROS DT Calibrator Kit.
Quality Control
|
:
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition* or other published guidelines.
MPORTANT:
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other creatinine
methods if they:
•
Commercial control fluids that contain ammonia concentrations above the VITROS NH3 DT Slide reportable range
(500 umol/L) will not allow a creatinine result to be calculated.
•
Reference Interval
These reference intervals are the central 95% of results from an internal study of apparently healthy adults from a working
population (90 females, 105 males).
Reference Interval for CREA DT
Female
Male
Conventional Units
(mg/dL)
0.7-1.2 mg/dL
0.8-1.5 mg/dL
SI Units
(umol/L)
62-106 umol/L
71-133 umol/L
Version 1.0
Pub. No. C-334
CREADT
Creatinine
The VITROS DT60/DT60 II Chemistry System may be programmed to report creatinine results in conventional and SI units.
Reporting Units and Unit Conversion for CREA DT
Conventional Units
Sl Units
mg/dL
Mmol/L (mg/dL x 88.4)
Known Interferences
•
|
•
Falsely elevated creatinine results have been reported for patients who have been given 5-fluorocytosine (flucytosine).9 An
alternate method should be used to determine serum creatinine from these patients.
Glucose at 600 mg/dL (33.3 mmol/L) may cause a decrease of 0.15 mg/dL (13.3 umol/L) in the creatinine result.
IMPORTANT:
|
•
VITROS CREA DT testing should not be done when any VITROS BUN/UREA DT
Slides are in the incubator.
If a VITROS CREA DT Slide follows a VITROS BUN/UREA DT Slide immediately, high BUN values may increase
creatinine values. A BUN value up to 40 mg/dL (14.3 mmol/L) may increase creatinine value by 0.3 mg/dL (26.6 umol/L)
and an R18 code will be printed next to the creatinine result. Discard the result and repeat the sample without the VITROS
BUN/UREA DT Slide in the incubator.
Other Limitations
Certain drugs and clinical conditions are known to alter creatinine concentration in vivo. For additional information, refer to one
of the published summaries.10 "
Method Comparison
I
using the HPLC comparative method.6
Method Comparison for CREA DT: Serum
SI Units
Conventional Units
1400
IS
2
y =x
1200
p
1000
800
600
400
200
0
12
0
15
200 400 600 800 1000 1200 1400
Comparative Method: HPLC
(Mmol/L)
(mg/dL)
Method Comparison for CREA DT: Serum
n
DT60 II System vs.
comparative method
39
Correlation
Slope Coefficient
1.03
0.992
Range of
Sample Cone.
0.7-11.5
Pub. No. C-334
Intercept Sy.x
0.04
0.44
SI Units (|jmol/L)
Range of
Sample Cone.
Intercept
Sy.x
58-1017
3.61
39.23
Version 1.0
CREADT
References
Creatinine
Precision
Precision for CREA DT:Serum
SI Units (umol/L)
Mean
Cone.
System
VITROS DT60 II
Within
Day SD*
Within
Lab S D "
Mean
Cone.
Within
Day SD*
Within
Lab S D "
Within
Lab
CV%**
No.
Observ.
No.
Days
1.0
0.05
0.06
93
4.1
5.6
6.1
83
21
5.1
0.15
0.20
455
13.5
17.5
3.8
84
21
References
1.
2.
4.
1991.
1991.
6. Ambrose RT, Ketchum DF, Smith JW. Creatinine Determined by "High Performance" Liquid Chromatography. Clin. Chem. 29: 256-259;
1983.
7. Jaffe M. Uber den Niederschlag welchen Pikrinsaure in normalen Harn erzeugt und uber eine neue Reaktion des Kreatinins. Z Physiol
Chem. 10: 391-400; 1886.
9. Mitchell RT, Marshall LH, Lefkowitz LB, Stratton CW. Falsely Elevated Serum Creatinine Levels Secondary to the Presence of 5Fluorocytosine. Am. J. Clin. Path. 84: 251-253; 1985.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Date (YYYY-MM-DD)
Lot Number
Attention: See
Version 1.0
REJ> J
"\ v /
V
|
Store At or Above
Pub. No. C-334
CREADT
Revision History
Creatinine
Revision History
Date of
Revision
2003-10-01
Version
1.0
> New format
> Specimens Recommended - updated wording for heparin; added EDTA
> Specimen Storage and Stability - updated stability values
> Sample Dilution - added VITROS 7% BSA; removed isotonic saline
> Reference Interval - updated data
> Limitations of the Procedure - updated values
> Method Comparison - updated all comparisons and the plots
> References - added all
Obsolete Date
Signature
C€
Mandeville House
62 The Broadway
Amersham
England
êUmon company
Pub. No. C-334
Version 1.0
(Products
VITRfflS
Chemistry!
CRSCDT
VITROS Chemistry Products CRSC DT Slides
Creatinine
Intended Use
VITROS CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma.
Serum creatinine excretion is a function of lean body mass in normal persons and shows little or no response to dietary
changes. The serum creatinine concentration is higher in men than in women.
Serum creatinine is increased in acute or chronic renal failure, urinary tract obstruction, reduced renal blood flow, shock,
dehydration, and rhabdomyolysis. Causes of low serum creatinine concentration include debilitation and decreased muscle
mass. Exercise may cause an increased creatinine clearance.
The VITROS CRSC DT Slide method is performed using the VITROS CRSC DT Slide and the VITROS Chemistry Products
The VITROS CRSC DT Slide is a multilayered, analytical element coated on a polyester support.
Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is
converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is
oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a
leuco dye to produce a colored product.
Following addition of the sample, the slide is incubated. During the initial reaction phase, endogenous creatine in the sample is
oxidized. The rate of change in reflection density is proportional to the concentration of creatinine present in the sample.
Reaction Sequence
creatinine amidohydrolase
creatinine + H2O
creatine
creatine amidinohydrolase
creatine + H2O sarcosine + O2 + H2O
sarcosine + urea
sarcosine oxidase
peroxidase
H2O2 + leuco dye
glycine + formaldehyde + H2O2
dye + 2H2O
Test Type and Conditions for CRSC DT
Test Type
Rate
Version 1.0
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Pub. No. C-353
Temperature
37°C (98.6°F)
Wavelength
680 nm
Sample Drop
Volume
10 ML
CRSC or
Creatinine
Reagents
Slide Diagram
Slide Ingredients
3. Reagent layer
• creatinine amidohydrolase
• creatine amidinohydrolase
• sarcosine oxidase
• peroxidase
• leuco dye
• buffer, pH 7.0
2
Creatinine amidohydrolase (Flavobacterium sp., E.C.3.5.2.10) 0.20 U; creatine
amidinohydrolase {Flavobacterium sp., E.C.3.5.3.3) 4.7 U; sarcosine oxidase
(Bacillus sp., E.C.1.5.3.1) 0.55 U; peroxidase (horseradish root, E.C.1.11.1.7)
1.6 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4-dimethylaminophenyl)
imidazole (leuco dye) 32 ng.
4. Support layer
Other ingredients
Pigment, binders, surfactants, stabilizer, scavenger, chelator, buffer, dye
solubilizer and cross-linking agent.
Slide Handling
Slide Preparation
IMPORTANT;
opened.
(64°-82°F) for >48 hours.
1.
2.
VITROS CRSC DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for CRSC DT
Slides
Unopened
Opened
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C (64°-82°F)
Pub. No. C-353
Stability
<48 hours
<15 minutes
Version 1.0
CRSGDT
Creatinine
• Serum
• Plasma:2
MPORTANT:
I
Heparin
•
Do not use specimens obtained through catheters used to infuse hyperalimentation fluid. Refer to "Limitations of the
Procedure."
Serum and Plasma
Patient Preparation
Special Precautions
• Centrifuge specimens and remove the serum or plasma from the cellular material within 4 hours of collection.6
Specimen Storage and Stability for CRSC DT: Serum and Plasma6
Temperature
Storage
Stability
Room temperature
Refrigerated
Frozen
18°-28OC(64°-82OF)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<5 days
<30 days
<lndefinite
Testing Procedure
Materials Provided
•
VITROS Chemistry Products CRSC DT Slides
•
•
.
•
.
Isotonic saline
VITROS DT Pipette
•
IMPORTANT:
immediately.
Sample Dilution
If creatinine concentrations exceed the system's reportable (dynamic) range or if the analyzer displays an L-11 or L-13 error
code (indicating high background density, usually due to an elevated creatine concentration):
1. Dilute the sample with 7% BSA or isotonic saline.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's creatinine concentration.
Version 1.0
Pub. No. C-353
CRSCDT
Creatinine
Calibration
Calibration
When to Calibrate
Calibrate:
The VITROS CRSC DT test may also need to be calibrated:
Calculations
activity. Once a calibration has been performed for each slide lot, creatinine concentration in unknown samples can be
a calibration.
Reportable (Dynamic) Range for CRSC DT
0.1-16.5
SI Units (umol/L)
4-1459
(National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 914a. The
Ortho-Clinical Diagnostics calibration laboratory, uses SRM® 914a to calibrate selected measurement procedures, including an
HPLC (High Performance Liquid Chromatography)7 method and a rate Jaffe8 method, to support creatinine value assignment
Quality Control
|
•"
•
•
•
4
System.
Pub. No. C-353
Version 1.0
CRSC DT
•
•
•
Creatinine
IMPORTANT:
•
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other creatinine
methods if they:
Liquid serum often contain high creatine levels and may give L-11 or L-13 error codes.
Refer to the instructions for use for VITROS Chemistry Products DT Control I & I or to other manufacturer's product literature.
Reference Interval
population (105 males, 90 females).
Reference Interval for CRSC DT
Conventional Units
(mg/dL)
0.8-1.5
0.7-1.2
Male
Female
SI Units
(umol/L)
71-133
62-106
The VITROS DT60/DT60 II Chemistry System may be programmed to report creatinine results in conventional and SI units.
Reporting Units and Unit Conversion for CRSC DT
Conventional Units
SI Units
mg/dL
umol/L (mg/dL x 88.4)
Known Interferences
Creatine: At a creatinine concentration of 1.5 mg/dL (133 umol/L), creatine greater than 8 mg/dL (707 umol/L) will be
flagged with an L-11 error code (because highly elevated creatine concentrations may cause excessive background
density). For unflagged samples, residual bias because of creatine will be less than 0.15 mg/dL (13 umol/L) at low
creatinine concentrations. Residual bias for unflagged samples will be less than 4% at high creatinine concentrations. Refer
to "Sample Dilution" for dilution instructions.
Proline: Patients receiving hyperalimentation fluids containing proline may show an increase of 0.2 mg/dL (18 umol/L). Do
not collect specimens from intravenous fluid lines contaminated with hyperalimentation fluid.
Dobutamine: Specimens contaminated with dobutamine from intravenous fluid have been reported to show a significant
negative bias. A dobutamine concentration of 83 ug/mL caused a decrease of 2.7 mg/dL (239 umol/L) from an initial
creatinine concentration of 4.8 mg/dL (424 umol/L).10
Lidocaine: Patients on long-term lidocaine therapy may show an increase of up to 1.0 mg/dL (88 umol/L) due to a
metabolite of lidocaine, N-ethyl glycine (NEG).11
Version 1.0
Pub. No. C-353
CRSC DT
Creatinine
The VITROS CRSC DT Slide method was screened for interfering substances. The substances listed in the table, when tested
at the concentrations indicated, caused the bias shown.
Known Interfering Substances for CRSC DT
Creatinine Concentration
SI (umol/L)
Conv. (mg/dL)
Interferent
Concentration
Interferent*
Dipyrone (Metamizol)
Average Bias
SI (|jmol/L)
Conv. (mg/dL)
-0.6
(-53)
(-35 umol/L)
-0.4 mg/dL
40mg/dL
(1138 Mmol/L)
1.0
(88)
(115 pmol/L)
/V-acetylcysteine
90 mg/dL
(5.50 mmol/L)
1.3 mg/dL
* It is possible that other interfering substances may be encountered. These results are representative; however, your results may differ
Other Limitations
of the published summaries.12 "
Method Comparison
I
The plots and table show the results of a comparison of the VITROS DT60 II Chemistry System with the VITROS 950
Chemistry System.
Method Comparison for CRSC DT: Serum
Conventional Units
IX
SI Units
1500
y =x
y =x
1200
15 12
900
9
D
w
O
1
600
O
300
6
0
12
IS
15
300
600
900
1200
1500
(Mmol/L)
(mg/dL)
Method Comparison for CRSC DT: Serum
n
DT60 II System vs.
comparative method
70
Correlation
Slope Coefficient
0.97
0.999
Range of
Sample Cone.
0.7-12.2
Pub. No. C-353
Intercept Sy.x
0.1
0.19
SI Units (Mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
58-1077
8.86
16.72
Version 1.0
CRSCDT
References
Creatinine
Precision
Precision was evaluated with quality control materials on VITROS the DTSC II System following NCCLS Protocol EP5.'4
Precision for CRSC DT:Serum
SI Units (umol/L)
Mean
Cone.
System
VITROS DT60 II
Within
Day SD*
Within
Lab SD**
Mean
Cone.
Within
Day SD*
Within
Lab SD**
Within
Lab
CV%**
No.
Observ.
No.
Days
1.2
0.01
0.02
110
1.1
1.5
1.3
88
22
5.9
0.06
0.10
521
5.1
8.8
1.7
88
22
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
1991.
1991.
Ambrose RT, Ketchum DF, Smith JW. Creatinine Determined by "High Performance" Liquid Chromatography. Clin. Chem. 29: 256-259;
1983.
Jaffe M. Uber den Niederschlag welchen Pikrinsaure in normalen Harn erzeugt und uber eine neue Reaktion des Kreatinins. Z Physiol
Chem. 10:391-400; 1886.
DalyT, Kempe K, Scott M. "Bouncing" Creatinine Levels. NEJM. 334(26): 1749; 1996.
Sena SF, Syed D, Romeo R, Krzymowski GA, McComb RB. Lidocaine Metabolite and Creatinine Measurements in the Ektachem 700:
Steps to Minimize its Impact on Patient Care. Clin. Chem. 34:10; 1988.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Date (YYYY-MM-DD)
Lot Number
Version 1.0
[ EC [ BEP |
\ £/
\ /
Pub. No. C-353
VITRÎS 0
CRSC DT
Revision History
Creatinine
Revision History
Date of
Revision
2003-04-30
Version
1.0
New format
Specimen Storage and Stability - updated values for room temperature and
refrigerated
• Materials Required But Not Provided - added VITROS 7% BSA; deleted isotonic
saline
• Reportable (Dynamic) Range - corrected SI units
• Quality Control Material Selection - removed the statement regarding Tris buffer
• Limitations of the Procedure - updated information and corrected creatinine
concentration in SI units
• Method Comparison - updated all data and plots
•
•
•
When this Instructions For Use is replaced, sign and date beiowand retain as specified by local regulations or laboratory
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
weH company
Pub. No. C-353
Version 1.0
Prodwcts
Chemistry
FeDT
INSTRUCTIONS FOR OSE
VITROS Chemistry Products Fe DT Slides
Iron
Intended Use
VITROS Fe DT Slides quantitatively measure iron (Fe) concentration in serum and plasma.
Most body iron is found in hemoglobin. The serum measurement of iron is useful in the differential diagnosis of anemia, iron
deficiency anemia, thalassemia, possible sideroblastic anemia, and iron poisoning.
Serum iron is increased in hemosiderosis, hemolytic anemias, thalassemia, sideroblastic anemias, hepatitis, acute hepatic
necrosis, hemochromatosis, inappropriate iron therapy, and iron poisoning. Serum iron is decreased in cases of insufficient
dietary iron, chronic blood loss, inadequate absorption of iron, impaired release of iron stores (commonly observed in
inflammation), infection, and chronic diseases.1
The VITROS Fe DT Slide method is performed using the VITROS Fe DT Slide and the VITROS Chemistry Products
The VITROS Fe DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Iron
(as ferric ion) is removed from transferrin at acidic pH and migrates to the reducing layer, where ascorbic acid reduces iron to
the ferrous form.
The ferrous ion then is bound to the dye and forms a colored complex in the reagent layer. The rate of change in reflection
density is proportional to the iron concentration in the sample.
Reaction Sequence
pH4.0
transferrin - Fe*
Fe
- > • transferrin + Fe+:
->Fe+
+ ascorbic acid
- > • Fe+2 - dye (colored complex)
Fe+2 + dye
Test Type and Conditions for Fe DT
Test Type
Rate
VITROS DT60 II
Module
DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
630 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-371
FeDT
Reagents
Iron
Reagents
Slide Diagram
Slide Ingredients
--
2
Ascorbic acid 160 ug; and N-(4-(2,4-bis(1,1-dimethylpropyl) phenoxy)butyl)5-methoxy-6((2,3,6,7-tetrahydro-8-1H,5H-benzo-(ij)-quinolizin-9-yl)azo)3-pyridine sulfonamide (dye) 5 ug.
y'
/'
Other ingredients
'3
- s
Binders, buffer, pigment, surfactants, stabilizer, chelator, dye solubilizer and
cross-linking agent.
•
2. Spreading layer (BaSOit)
3. Reducing layer
• ascorbic acid
4. Reagent layer
• buffer, pH 4.0
• dye
6. Support layer
$
Slide Handling
Slide Preparation
IMPORTANT:
The slide must reach mom temperature, 18°-28°C (64°-82°F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS Fe DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for Fe DT
Slides
Storage Condition
Unopened
Room temperature
Refrigerated
Frozen
Room temperature
Opened
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
•
•
Serum
Plasma:
IMPORTANT;
Heparin
•
Do not use hemolyzed specimens because of the high concentration of iron in hemoglobin.1
Pub.
No. C-371
Version 1.0
[•] VITRI
FeDT
Testing Procedure
Iron
Serum and Plasma
Patient Preparation
Special Precautions
•
•
Specimen Storage and Stability for Fe DT: Serum and Plasma6
Temperature
Stability
Storage
Room temperature
<4 days
18°-28°C (64°-82°F)
Refrigerated
<7 days
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
<3 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products Fe DT Slides
•
•
•
•
Iron-free reagent-grade water
VITROS DT Pipette
•
I
analysis.
Sample Dilution
If iron concentrations exceed the system's reportable (dynamic) range:
1. Dilute the sample with iron-free reagent-grade water.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's Iron concentration.
Calibration
Version 1.0
Pub. No. C-371
FeDT
Iron
Quality Control
When to Calibrate
Calibrate:
The VITROS Fe DT test may also need to be calibrated:
Calculations
Reflectance from the slide is read at 630 nm during the incubation period, and the rate of change in reflectance is calculated.
Once a calibration has been performed for each slide lot, iron concentration in unknown samples can be determined using the
software-resident two-point rate math model and the change in reflectance calculated for each unknown test slide.
a calibration.
Reportable (Dynamic) Range for Fe DT
Conventional (ug/dL)
10-500
SI Units ((jmol/L)
1.8-89.6
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for iron are traceable to the Certified NIST (National
Institute of Standards and Technology) Reference Material, SRM" (Standard Reference Material) 937. The Ortho-Clinical
Diagnostics (OCD) calibration laboratory uses SRM" 937 to calibrate the proposed NCCLS standard iron method,7 modified
according to the International Committee for Standardization in Hematology (ICSH) recommendation to use ferene dye,8 to
support iron value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
•
•
•
•
•
•
- After specified service procedures are performed. Refer to the operator's manual for your VITROS DT60 II System.
For general quality control recommendations, refer fo Statistical Quality Control for Quantitative Measurements: Principles
Pub. No. C-371
Version 1.0
FeDT
Iron
IMPORTANT:
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other Iron methods if
they:
- Contain high concentrations of preservatives, stabilisers, or other nonphysiological additives.
Reference Interval
Reference Interval for Fe DT
Conventional Units
(Mg/dL)
Females
Males
37-170
49-181
SI Units
(umol/L)
6.6-30.4
8.8-32.4
Reporting Units [and Unit Conversion]
The VITROS DT60 II Chemistry System may be programmed to report Fe results in conventional and SI units.
Reporting Units and Unit Conversion for Fe DT
Conventional Units
Mg/dL
SI Units
Mmol/L (ug/dL x 0.1791)
Known Interferences
The VITROS Fe DT Slide method was screened for interfering substances following NCCLS Protocol EP7.10 The substances
• Desferol (Deferoxamine Mesylate) at a concentration of 250 mg/dL and higher results in iron concentrations below the
system range.
• Imferon produces a positive iron bias of 5 ,ug/dL for each 100 i-ig/dL of imferon.
|
Other Limitations
Certain drugs and clinical conditions are known to alter Iron concentration in vivo. For additional information, refer to one of the
published summaries.11'12
Version 1.0
Pub. No. C-371
FeDT
Iron
Method Comparison
I
Method Comparison for Fe DT: Serum
Conventional Units
600 •
SI Units
100
y=x
500 "
80
E
400
60
300 '
2O0 •
8
O
100 "
20
0
100
300
200
400
500
600
20
40
60
80
too
(Mmol/L)
(Mg/dL)
Method Comparison for Fe DT: Serum
Conventional Units (pg/dL)
n
DT60 II System vs.
comparative method
53
Correlation
Slope Coefficient
1.03
0.999
Range of
Sample Cone.
19-448
Intercept Sy.x
-1.47
4.71
SI Units (umol/L)
Range of
Sample Cone.
Intercept Sy.x
3.5-80.2
-0.26
0.84
Precision
Precision for Fe DT: Serum
System
VITROS DT60 II
Conventional Units (Mg/dL)
Within
Within
Day SD* Lab SD**
Mean
Cone.
Mean
Cone.
SI Units (Mmol/L)
Within
Within
Day SD* Lab SD**
Within
Lab
CV%**
No.
Observ.
No.
Days
72
1.6
2.2
12.8
0.28
0.39
3.0
88
22
240
4.6
6.7
43.0
0.83
1.20
2.8
88
22
Pub. No. C-371
Version 1.0
FeDT
References
Iron
References
1.
.2.
3.
4.
1991.
5.
6.
7.
8.
1991.
NCCLS. The Determination of Serum Iron and Total iron binding-capacity; Proposed Standard. NCCLS Document H17-P. Wayne, PA:
NCCLS; 1990.
Iron Panel of the International Committee for Standardization in Haematology. Revised Recommendations for the Measurements of
Serum Iron In Human Blood. Br J Haematology. 75:615-616; 1990.
9.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date (YYYY-MM-DD)
Lot Number
^1
| EC [ HEP j
S, v'7
V
Number
Version 1.0
Manufacturer
Store Between
Use
Tests
Care.
Keep Dry
This end up
Catalog Number or
Product Code
JT
Store At or Below
Attention: See
Jf
Store At or Above
Pub. No. C-371
VI"TFJCp*S 0
FeDT
Revision History
Iron
Revision History
Date of
Revision
2003-10-01
Version
1.0
• New format
> Known Interferences - removed statement regarding cupramine; updated bias
value for imferon
> Method Comparison - updated all comparisons and plots
Precision - updated all data
> References - added all except 4,11,12
Obsolete Date
Signature
C€
REP
Mil
Mandeville House
62 The Broadway
Amersham
England
company
Pub. No. C-371
Version 1.0
Produ cts
VITR
Chemistry
VITROS Chemistry Products GGT DT Slides
GGTDT
Gamma Glutamyltransferase
Intended Use
VITROS GGT DT Slides quantitatively measure gamma glutamyltransferase (GGT) activity in serum and plasma.
y-Glutamyltransferase plays a major role in glutathione metabolism and in resorption of amino acids from the glomerular filtrate.
It is also important in the absorption of amino acids from the intestinal lumen. GGT is found mainly in the liver, pancreas, and
kidney, although lower activities can be demonstrated in most other organs.
Serum GGT is a sensitive indicator of hepatobiliary disease and is useful in the diagnosis of obstructive jaundice and chronic
alcoholic liver disease, in the follow-up of chronic alcoholics undergoing treatment, and in the detection of hepatotoxicity. GGT
is more responsive to biliary obstruction than AST, ALT, or ALKP. GGT is also increased in hepatoma, carcinoma of the
pancreas, and carcinoma metastatic to the liver.1
The VITROS GGT DT Slide method is performed using the VITROS GGT DT Slide.and the VITROS Chemistry Products
The VITROS GGT DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. GGT
catalyzes the transfer of the y-glutamyl portion of L-y-glutamyl-p-nitroanilide to glycylglycine, simultaneously producing
p-nitroaniline. The rate of change in reflection density is measured and is used to calculate the enzyme activity of GGT.
Reaction Sequence
p-nitroaniline + y-glutamyl glycylglycine
L-y-glutamyl-p-nitroanilide + glycylglycine
Test Type and Conditions for GGT DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
400 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-343
GGTDT
Reagents
Reagents
Slide Diagram
Slide Ingredients
2
Glycylglycine 0.2 mg; and L-y-glutamyl-p-nitroanilide 16 ug.
t
.
*
3
\r
Other ingredients
Polymer beads, binders and surfactants.
.
-"" '_,
2. Spreading layer (beads)
3. Reagent layer
•
•
•
buffer, pH 8.0
glycylglycine
L-7-glytamyl-p-nitroanilide
4. Support layer
Lower slide mount
^
- 8
Slide Handling
Slide Preparation
IMPORTANT:
Theslide must reach room temperature, 18°-28°C (64°-82°F), before the wrapperis
opened.
(64 "-82 °F) for >48 hours.
VITROS GGT DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for GGT DT
Storage Condition
Slides
Room temperature
18°-28°C (64°-82°F)
Unopened
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
Room temperature
18°-28°C (64°-82°F)
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
Serum
Plasma:
EDTA
Heparin
Serum and Plasma
Patient Preparation
Special Precautions
• For the affect of high concentration of bilirubin on test results, refer to "Limitations of the Procedure."
Pub. No. C-343
Version 1.0
| i | V1TRI
GGT DT
Testing Procedure
•
•
Specimen Storage and Stability for GGT DT: Serum and Plasma6
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<7 days
<7 days
<2 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products GGT DT Slides
•
•
•
•
.
Isotonic saline
VITROS DT Pipette
•
IMPORTANT;
analysis.
Sample Dilution
If gamma glutamyltransferase concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's gamma glutamyltransferase activity.
|
Calibration
When to Calibrate
Calibrate:
The VITROS GGT DT test may also need to be calibrated:
Version 1.0
Pub. No. C-343
GGTDT
Quality Control
Calculations
activity. Once a calibration has been performed for each slide lot, gamma-glutamyltransferase activity in unknown samples can
be determined from the rate of change in reflectance measured for each unknown test slide.
a calibration.
Reportable (Dynamic) Range for GGT DT
5-1400
I
I
Values assigned to the VITROSChemistry Products DT Calibrator Kit for gamma-glutamyltransferase are traceable to the
gamma-glutamyltransferase method recommended by the International Federation of Clinical Chemistry (IFCC),7 adapted to a
centrifugal analyzer at 37°C.
Quality Control
|
WA R N l N G:
•
•
•
•
•
•
System.
I
IMPORTANT:
•
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other gamma
glutamyltransferase methods if they:
Pub. No. C-343
Version 1.0
GGTDT
Reference Interval
These reference intervals are the central 95% of results from an external study of 493 apparently healthy adult volunteers
(277 females and 216 males).9 The study was conducted following NCCLS Protocol C28.10
Reference Interval for GGT DT
(U/L)
Adult
Females
12-58
12-43
Males
15-73
The VITROS DT60/DT60 II Chemistry System may be programmed to report gamma glutamyltransferase results in
conventional and SI units.
Reporting Units for GGT DT
U/L
Known Interferences
The VITROS GGT DT Slide method was screened for interfering substances following NCCLS Protocol EP7.11 The substances
Known Interfering Substances for GGT DT
Interferent*
Bilirubin**
*
**
Interferent
Concentration
40 mg/dL
40 mg/dL
(684 umol/L)
(684 umol/L)
Gamma
Glutamyltransferase
Activity
190
1100
Average Bias
+6
-460
Grossly elevated concentrations
Other Limitations
Certain drugs and clinical conditions are known to alter gamma glutamyltransferase activity in vivo. For additional information,
Version 1.0
Pub. No. C-343
GGTDT
Method Comparison
I
Method Comparison for GGT DT: Serum
1500 1
y =x
1200 "
900 "
600 •
o
300 "
0
300
900
600
1200
1500
Comparative Method: VITROS 950 Systam
(U/L)
Method Comparison for GGT DT: Serum
Correlation
Range of
Slope Coefficient Sample Activity Intercept Sy.x
n
DT60 II System vs.
950 System
60
1.00
0.999
18-1296
4.63
20.83
Precision
Precision for GGT DT: Serum
System
VITROS DT60 II
Mean Activity
Within Day SD*
No Observ.
No. Days
77
0.5
1.0
1.3
88
22
417
3.4
4.7
1.1
87
22
Pub. No. C-343
Version 1.0
GCTDT
References
References
1.
2.
3. Calam RR. Specimen Processing Separator Gels: An Update. J. Clin. Immunoassay. 11:86-90; 1988.
4.
1991.
1991.
7. Shaw L M, Stromme J H, London JL, Theodorsen L. IFCC methods for the measurement of catalytic concentration of enzymes. Part
4. IFCC method forgamma-glutamyltransferase. J, Clin. Chem. Clin. Biochem. 21: 633-646; 1983.
9. Neels H, Van Boeckel E, Wauters A. Algemeen Ziekenhuis Middelheim, 1998. Data on file.
10. NCCLS. How to Define and Determine Reference Intervals in the Clinical Laboratory; Approved Guideline. NCCLS document
C28-A (ISBN 1-56238-269-1). NCCLS, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087, 1995.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Version 1.0
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
SN
Number
Keep Dry
REF
Catalog Number or
Product Code
Store At or Below
This end up
A
Attention: See
Store At or Above
Pub. No. C-343
GGTDT
Revision History
Revision History
Date of
Revision
2003-08-11
Version
1.0
> New format
« Specimen Collection and Preparation - removed statement regarding hemolyzed
specimens.
> Materials Required But Not Provided - added VITROS 7% BSA
> Limitations of the Procedure - added the Known Interfering Substances table
• Method Comparison - updated comparisons and the plot
> Precision - updated all values
> References - added all except 9, 10
4
1
*
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
<4ôfMMeH company
Pub. No. C-343
Version 1.0
I P roducts
VITRmB
Chemistry!
GLUDT
INSTRUCTIONS fOR USE
VITROS Chemistry Products GLU DT Slides
Glucose
Intended Use
VITROS GLU DT Slides quantitatively measure glucose (GLU) concentration in serum and plasma.
Glucose is a primary cellular energy source. Fasting plasma glucose concentrations and tolerance to a dose of glucose are
used to establish the diagnosis of diabetes mellitus and disorders of carbohydrate metabolism. Glucose measurements are
used to monitor therapy in diabetics and in patients with dehydration, coma, hypoglycemia, insulinoma, acidosis, and
ketoacidosis.1
The VITROS GLU DT Slide method is performed using the VITROS GLU DT Slide and the VITROS Chemistry Products
The VITROS GLU DT Slide is a multilayered, analytical element coated on a polyester support.
oxidation of sample glucose is catalyzed by glucose oxidase to form hydrogen peroxide and gluconate. This reaction is
followed by an oxidative coupling catalyzed by peroxidase in the presence of dye precursors to produce a dye. The intensity of
the dye is measured by reflected light.
The dye system used is closely related to that first reported by Trinder.2The chemistry of the glucose slides has been described
by Curme, et al.3
Reaction Sequence
p-D-glucose + O2 + H2O
glucose oxidase
D-gluconic acid + H2O2
2H2O2 + 4-aminoantipyrine + 1,7-dihydroxynaphthalene
peroxidase
->•
red dye
Test Type and Conditions for GLU DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 |jL
Version 1.0
Pub. No. C-300
VITR
GLUDT
Glucose
Reagents
Reagents
Slide Diagram
Slide Ingredients
__
-
-
'
t
2
Glucose oxidase (Aspergillus Niger, E.C.1.1.3.4) 0.77 U; peroxidase (horseradish
root, E.C.1.11.1.7) 3.6 U; 1,7-dihydroxynaphthalene (dye precursor) 67 \ig and
4-aminoantipyrine hydrochloride (dye precursor) 0.11 mg.
*~
--
4
Other ingredients
2 Spreading layer (TIO2)
Reagent layer
• glucose oxidase
• peroxidase
• dye precursors
• buffer, pH 5.0
4. Support layer
S. Lower slide mount
Pigment, binders, buffer, surfactants, stabilizers and cross-linking agent.
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18 "-2B <C (64 "-82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18°-28X!
(64 "-82 °F) for >48 hours.
1.
2.
VITROS GLU DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for GLU DT
Slides
Storage Condition
Specimen Type Used
All recommended specimens
Unopened*
Plasma (Sodium fluoride/
potassium oxalate)
Serum, Plasma (EDTA, Heparin)
Opened
All recommended specimens
Stability
Frozen
<-18°C (<0°F)
Refrigerated
2°-8°C (36°-46°F)
<4 months
Refrigerated
Room
temperature
2°-8°C (36°-46°F)
18°-28°C(64°-82°F)
<15 minutes
Do not store with or near hydrogen peroxide.
W&RN1NG:
•
.
Serum
Plasma:
I
I
I
EDTA
Heparin
Sodium fluoride/potassium oxalate (see the Slide Storage and Stability table for slide storage when using
this specimen type)
IMPORTANT:
Serum and Plasma
Pub. No. C-300
Version 1.0
0
VITF-jjnpS
GLURT
Testing Procedure
Glucose
Patient Preparation
Special Precautions
• Grossly lipemic samples must be diluted prior to analysis. Refer to "Sample Dilution "for dilution instructions.
• For the effect of elevated lipids on test results, refer to "Limitations of the Procedure."
• Particulate matter (for example, fibrin) in sufficient quantity may coat the spreading layer and limit diffusion of oxygen,
causing a negative interference. To minimize particulate matter, do not centrifuge specimens until clotting is complete.
• Serum:
- Centrifuge specimen at 1000X g for 10 minutes and remove serum from the clot within 30 minutes after collecting the
specimen to avoid metabolism of glucose by the cells (approximately 7% per hour at room temperature).6
• Heparin or EDTA plasma:
- Follow manufacturer's recommendations for mixing anticoagulant with specimens.
- Centrifuge specimen at 1000X g for 10 minutes and remove plasma from the cells within 30 minutes after collecting the
specimen to avoid metabolism of glucose by the cells (approximately 7% per hour at room temperature).6
• Sodium fluoride/potassium oxalate plasma:
- Follow manufacturer's recommendations for mixing anticoagulant with specimens.
- Centrifuge specimens and remove the plasma from the cells within 24 hours of collection.8
IMPORTANT:
See the Slide Storage and Stability table for slide storage when using sodium
fluoride/potassium oxalate plasma.
" *j
•
•
Specimen Storage and Stability for GLU DT: Serum and Plasma8
Temperature
Stability
Storage
18°-28OC(64°-82°F)
Room temperature
<24 hours
Refrigerated
2°-8°C (36°-46°F)
<7 days
Frozen
<-18°C(<0°F)
<1 year
Testing Procedure
Materials Provided
•
VITROS Chemistry Products GLU DT Slides
•
•
•
•
•
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If glucose concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's glucose concentration.
Version 1.0
Pub. No. C-300
GLUDT
Glucose
Calibration
Calibration
When to Calibrate
Calibrate:
The VITROS GLU DT test may also need to be calibrated:
Calculations
I
each slide lot, glucose concentration in unknown samples can be determined using the software-resident endpoint colorimetric
a calibration.
Reportable (Dynamic) Range for GLU DT
20-450
SI Units (mmol/L)
1.1-25.0
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for glucose are traceable to the Certified NIST (National
Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 917b. The Ortho-Clinical
Diagnostics calibration laboratory uses SRM® 917b to calibrate the CDC Hexokinase method9 to support glucose value
assignment for the VITROS DT Calibrator Kit.
Quality Control
|
>'
•
•
•
•
'
-
System.
Pub.
No. C-300
Version 1.0
GLUDT
Glucose
•
•
and Definitions; Approved Guideline-Second Bditionm or other published guidelines.
IMPORTANT:
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other glucose methods
if they:
Reference Interval
These reference intervals are based on external studies for serum.1
Reference Interval for GLU DT
Fasting adults
74-106
SI Units (mmol/L)
4.1-5.9
The VITROS DT60/DT60 II Chemistry System may be programmed to report glucose results in conventional and SI units.
Reporting Units and Unit Conversion for GLU DT
Conventional Units
SI Units
mg/dL
Known Interferences
•
In fresh specimens, catalase released from the lysis of red blood cells causes a negative bias in glucose results. The
degree of bias is proportional to the degree of hemolysis. In fresh samples, a negative bias of up to 10% may be observed
with a level of hemolysis associated with a hemoglobin concentration of 250 mg/dL (2.5 g/L).
NOTE:
Catalase activity decreases with sample storage. Aged samples that are hemolyzed
may exhibit a positive bias of up to 10% due to the spectral interference of
hemoglobin. Therefore, the magnitude and direction of bias observed with hemolyzed
specimens will vary due to the level of catalase activity and concentration of
hemoglobin present in the sample.
• Elevated lipids may limit diffusion of oxygen to the reactants. Dilute grossly lipemic samples before analysis.
The VITROS GLU DT Slide method was screened for interfering substances following NCCLS Protocol EP7.12 The substances
Known Interfering Substances for GLU DT
Interfered*
Interferent
Concentration
5 g/dL
10g/dL
(50 g/L)
(100 g/L)
Glucose Concentration
Conv. (mg/dL)
SI (mmol/L)
100
5.55
100
5.55
Average Bias
Conv. (mg/dL) SI (mmol/L)
-5
-0.28
+6
+0.33
Version 1.0
Pub. No, C-300
GIUDT
Glucose
Other Limitations
Certain drugs and clinical conditions are known to alter glucose concentrations in vivo. For additional information, refer to one
of the published summaries. 13 ' u
Method Comparison
I
Method Comparison for G L U DT: Serum
Conventional Units
g-
I
I
a
ft
SI Units
500 •
450 *
400 •
30
350 "
300 "
£
2()
o
|
5
150 "
100 •
0 •
50
20
a>
»
15
Q
10
250 '
I
y =x
<> "
5
0
100
200
300
500
400
10
15
20
25
30
(mmol/L)
(mg/dL)
Method Comparison for GLU DT: Serum
n
DT60 II System vs.
950 System
55
Correlation
Slope Coefficient
1.02
1.000
Range of
Sample Cone.
Intercept
Sy.x
25-445
0.67
3.78
SI Units (mmol/L)
Range of
Sample Cone. Intercept
1.4-24.7
Sy.x
0.04
0.21
Precision
Precision was evaluated with quality control materials on the VITROS DT60 II System following NCCLS Protocol EP5.' 6
Precision for GLU DT: Serum
System
VITROS DT60 II
Mean
Cone.
91
309
Within
Day SD*
1.0
3.8
Within
Lab SD**
1.7
4.4
SI Units (mmol/L)
Mean
Within
Within
Cone.
Day SD* Lab SD**
5.0
0.05
0.09
17.2
0.25
0.21
Within
Lab
CV%**
1.8
1.4
No.
Observ.
No.
Days
88
88
22
22
Pub. No. C-300
Version 1.0
GLUDT
References
Glucose
References
1.
2.
5.
6.
Tietz NW(ed). Textbook of Clinical Chemistry, ed. 2. Philadelphia: WB Saunders; 928-960; 1994.
Trinder P. Determination of Glucose in Blood Using Glucose Oxidase with an Alternative Oxygen Receptor. Ann. Clin. Biochem. 6:24;
1969.
Curme HG, et al. Multilayer Film Elements for Clinical Analysis. Clin. Chem. 24:1335-1342; 1978.
7.
3.
4.
1991.
1991.
8.
9. Neese JW, Duncan P, Bayse DD, et al. Development and Evaluation of a Hexokinase/Glucose-6-phosphate Dehydrogenase
Procedure for Use as a National Glucose Reference Method. HEW Publication No. (CDC) 77-8330. HEW. USPHS, Centers for
Disease Control; 1976.
11. Tietz NW (ed). Textbook of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 1815; 1999.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Date (YYYY-MM-DD)
Lot Number
Version 1.0
EC | REP I
\ y /
\/
Pub. No. C-300
GLUDT
Revision History
Glucose
Revision History
Date of
Revision
2003-08-11
Version
1.0
New format
Slide Storage and Stability - added the Specimen Type Used column; updated
storage values for opened cartridges
• Specimens Recommended - added sodium fluoride/potassium oxalate
• Reference Interval - updated data
• Limitations of the Procedure - deleted statement regarding ascorbic acid;
updated data for hemolysis
• Method Comparison - updated all comparisons and plots
• Precision - updated values
•
•
•
Obsolete Date
Signature
C€
EC
Mandeville House
62 The Broadway
Amersham
England
a flohtM«M«jjefMM8H company
Pub.
No. C-300
Version 1.0
IProducts
VITRQ35
Chemistry!
HDLC DT
VITROS Chemistry Products
DT Micro HDL Cholesterol Kit
Micro HDL Cholesterol
Intended Use
For use in the quantitative measurement of HDL cholesterol (HDLC) concentration in serum and plasma.
HDL cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with
lower HDL cholesterol concentrations.
VITROS DT Micro HDL Cholesterol Kit is used to prepare and test samples for high density lipoprotein (HDL) cholesterol on
VITROS DT60/DT60 II Chemistry Systems. The specimens must initially be treated with a reagent to remove other lipoproteins
which also contain cholesterol, including the very low density (VLDL) and low-density (LDL) classes. The amount of HDL
cholesterol can then be determined using VITROS Chemistry Products HDLC DT Slides.
HDL is separated by the precipitation of LDL and VLDL using dextran sulfate (MW 50,000) and magnesium chloride1 that is
provided in the VITROS Chemistry Products DT Micro HDL Tube. The HDL lipoproteins remain in the liquid portion of the tube
after centrifugation. This liquid portion is called the supernate and is the portion analyzed. The non-HDL fractions form a pellet
on the bottom of the tube and are discarded.
A drop of pretreated patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying
layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters
from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol
ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen
The density of dye formed is proportional to the HDL cholesterol concentration present in the pretreated sample and is
measured by reflectance spectrophotometry.
Reaction Sequence
high density lipoproteins
->•
cholesterol oxidase
cholesterol + O2
peroxidase
H2O2 + leuco dye
- > cholesterol + fatty acids
- — > • cholest-4-en-3-one + H2O2
- > • dye + 2H2O
Test Type and Conditions for HDLC DT
Test Type
Colorimetric
Version 2.0
VITROS DT60/DT60 11
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Pub. No. C-354 EN
Temperature
37°C (98.6°F)
Wavelength
660 nm
Sample Drop
Volume
10 uL
VITRCp5 0
HDLC DT
While VITROS HDLC Sample Diluent product is bovine in origin, it should be handled using the same precautions as with any
other blood or blood-derived product.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the Instructions
for Use for the appropriate VITROS product, or to other manufacturer's product literature.
Personal Protection and Ventilation
Wear impervious gloves and proper protective clothing. Safety glasses are recommended. Good general ventilation in the work
area is recommended. Minimize the potential for production of aerosols.
Accidental Spillage and Disposal
WAP
VITROS DT Micro HDL Tubes contain sodium azide. Disposal of reagent into
sinks with copper or lead plumbing should be followed with plenty of water to
prevent formation of potentially explosive metallic azides.
Absorb spilled material in vermiculite or other suitable absorbents; sweep up and dispose of with clinical waste. Disinfect area
with a 5.25% sodium hypochlorite solution (household bleach) diluted with 9 parts water and leave undisturbed for at least 30
minutes. Excess or unwanted materials and packaging for this product should be disposed of with other clinical waste.
VITROS HDL Cholesterol Reagent contains sodium azide (0.01%; 0.01 g/dL). Disposal of reagent into sinks with copper or
lead plumbing should be followed with copious volumes of water to prevent formation of potentially explosive metallic azides.
First Aid
WARNSNC
•
•
•
•
VITROS DT Micro HDL Tubes contain gentamicin sulfate and sodium azide.
R22 - Harmful if swallowed.
Inhalation - Remove to fresh air. Seek medical advice.
Skin - Wash skin after each contact with soap and plenty of water for at least 15 minutes. Seek medical attention if skin is
cut or punctured.
Eye - Immediately flush eyes, including under the eyelids, with plenty of water for at least 15 minutes and get medical
attention.
Ingestion - Drink 1 -2 glasses of water. Seek medical advice.
Transportation
This product is not classified as a dangerous substance for transportation purposes. However, package with adequate
protection to prevent breakage and ship under refrigerated conditions.
Reagents
Slide Diagram
HDLC DT Slide Ingredients
1
2
2
Triton X-100 0.8 mg; cholesterol oxidase (Nocardia, E.C.1.1.3.6) 0.2 U;
cholesterol ester hydrolase (Candida rugosa, E.C.3.1.1.13) 0.7 U; peroxidase
(horseradish root, E.C.1.11.1.7) 5.3 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)4,5-bis-(4-dimethylaminophenyl) imidazole (leucodye) 0.2 mg.
Other ingredients
1 . Upper slide mount
2. Spreading layer (BaSCUl
• Triton X-100
cholesterol ester
hydrolase
cholesterol oxidase
peroxidase
leuco dye
3. Sublayer
• buffer, pH 6.25
4. Support layer
DT Micro HDL Tubes
Reactive Ingredients
Dextran sulfate (MW50,000) 0.08 mg, magnesium chloride hexahydrate 0.7 mg
Other ingredients
sodium azide 0.22%, gentamicin sulfate <0.01%, dye and preservatives
Pub. No. C-354 EN
Version 2.0
HDLC DT
HDLC Sample Diluent
Bovine serum albumin 7%
Other ingredients
Sodium azide 0.05%, inorganic salts and preservatives
Slide Handling
Slide Preparation
IMPORTANT:
opened.
(64 °-82°F) for >48 hours.
Kit Storage and Stability
VITROS DT Micro HDL Cholesterol Kit components are stable until the expiration date on the carton when they are stored and
handled as specified.
Kit Storage and Stability for HDLC DT
Kit Component
Storage Condition
Stability
Slide
Refrigerated
Frozen
Room temperature
Room temperature
Unopened
Opened
Tubes
Refrigerated
Frozen
2°-8°C (36°-46°F)
<-18°C(<0°F)
18°-28OC(64°-82°F)
18O-28°C(64O-82°F)
<48 hours
<15 minutes
2°-8°C (36°-46°F)
<-18°C(<0°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Sample Diluent*
Refrigerated
Frozen
* Discard if the solution becomes cloudy or turbid.
Verify performance with quality control materials:
- If the system is turned off for more than 2 hours.
•
•
Serum
Plasma:3
Heparin
.
Version 2.0
Plasma:5
EDTA
Pub. No. C-354 EN
VITH[fiS@
HDIC DT
Specimen Pretreatment and Testing Procedure
Serum and Plasma
Patient Preparation
• No special patient preparation is necessary unless the HDL cholesterol test is part of a complete lipid profile. Then,
a 12- to 14-hour fast is necessary.1
Special Precautions
• Centrifuge specimens and remove the serum from the cellular material within 3 hours of collection.8 If further processing is
delayed, store in the refrigerator at 2°-8°C (36°-46°F).
•' '
•
•
Specimen Storage and Stability for HDLC DT: Serum and Plasma8
Storage
Original Specimen
Refrigerated
Frozen
Pretreated Specimen (Supemate)
Temperature
2°-8°C (36°-46°F)
<-18°C (SO°F)
<-20°C (<-4°F)
<-70°C (<-94°F)
For longer storage, separate HDL fractions and freeze the supernate.
Freezer
*
|
IMPORTANT:
Stability
<3 days
<4 weeks*
<3 months
<2 years
Avoid repeated freeze-thaw cycles.
Materials Provided
•
•
•
25 VITROS Chemistry Products HDLC DT Slides
27 VITROS Chemistry Products DT Micro HDL Tubes
VITROS Chemistry Products HDLC Sample Diluent
•
•
.
•
•
•
•
VITROS Chemistry Products DT Controls I and II
VITROS DT Pipette
Pipette capable of accurately delivering 50 uL of serum or plasma to a VITROS DT Micro HDL Tube.
Centrifuge capable of generating forces of 1500 x g, or a microcentrifuge capable of generating forces of 12,600 x g.
Micro capillary collection device large enough to obtain at least 50 uL of serum or plasma.
A vortex mixer is recommended
Special Precautions
•
Use a vortex speed that will not cause the mixture to spill out of the sample tube.
Procedure
IMPORTANT;
Do not pretreat calibrators.
Be sure to use components from the same kit lot number.
IMPORTANT:
1. Allow at least 10 minutes for refrigerated VITROS DT Micro HDL Tubes and VITROS HDLC Sample Diluent to reach room
temperature. If these materials are stored at -18°C (0°F), they will require a longer warm-up period (at least 30 minutes).
Once opened, the VITROS Micro HDLC Sample Diluent should be stored tightly capped in the refrigerator between uses.
2. Pipette 50 uL of serum or heparin plasma into the VITROS DT Micro HDL Tube.
Pub. No. C-354 EN
Version 2.0
HDLCDT
Calibration
3. Cap and mix thoroughly for 30 seconds - a vortex mixer is recommended.
NOTE:
The sample will become cloudy during mixing.
4. Let stand for a minimum of 5 minutes.
5. Centrifuge the VITROS DT Micro HDL Tube for 10 minutes at 1,500 x g. Alternatively, you may centrifuge the tube for a
shorter duration using a microcentrifuge for 95 seconds at 12,600 x g.
6. Visually check supernates for clarity. The non-HDL fractions form a pellet on the bottom of the tube. Do not disturb the
pellet. If the supernate is clear, transfer cleared supernate directly from the VITROS DT Micro HDL Tube to a sample cup
for analysis on the DT analyzer.
IMPORT ANT:
Supernates should be removed from the pelleted precipitate as soon as possible
following centrifugation. The supernates should be used within 15 minutes. If analysis
on the VITROS DT60/DT60 II Chemistry System is to be delayed more than one hour,
the supernate should be refrigerated. If analysis is delayed longer than 8 hours, refer
to the "Specimen Handling and Storage" section.
7. Analyze treated sample as instructed in the operator's manual for your VITROS DT60/DT60 II Chemistry System.
•
IMPORTANT:
immediately.
Sample Dilution
If HDL concentrations exceed the system's reportable (dynamic) range or if the supernatant is cloudy or has floating particles
after pretreatment:
1. Dilute the untreated sample with an equal volume of VITROS HDLC Sample Diluent.
2. Mix gently by inverting several times.
3. Pipette 50 uL of the diluted specimen into a second VITROS DT Micro HDL Tube.
4. Repeat steps 1 through 6 of the procedure above. Remember to multiply the result by the dilution factor of 2.0.
5. Reanalyze.
6. Multiply the results by 2 to obtain an estimate of the original sample's HDL concentration.
NOTE:
Additional dilutions are not recommended.
Calibration
IMPORTANT:
When to Calibrate
Calibrate:
The VITROS HDLC DT slides may also need to be calibrated:
Version 2.0
Pub. No. C-354 EN
HDICDT
Quality Control
Calculations
each slide lot, high-density lipoprotein cholesterol concentration in unknown samples can be determined using the softwareresident endpoint colorimetric math model and the response obtained from each unknown test slide.
a calibration.
Reportable (Dynamic) Range for HDLC DT
SI Units (mmol/L)
0.03-2.84
1-110
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for High Density Lipoprotein-Cholesterol (HDLC)
Reagent with VITROS HDLC DT slides are traceable to the Certified NIST (National Institute of Standards and Technology)
Reference Material, SRM* (Standard Reference Material) 911b. The Ortho-Clinical Diagnostics Calibration Laboratory uses
SRM® 911b to assign values to secondary standards for calibration of an HDLC Selected Method. The Selected Method
supports VITROS HDL Cholesterol reagent value assignment for the VITROS DT Calibrator Kit. The HDLC Selected Method
includes (MW 50,000) Dextran Sulfate precipitation of non-HDL lipoproteins according to the recommendations of the Centers
for Disease Control (CDC),10 followed by automated enzymatic determination of supernate (HDL fraction) cholesterol
concentration.
Quality Control
IMPORTANT:
Controls must be pretreated.
|
..
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition'1'' or other published guidelines.
IMPORTANT:
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other HDL cholesterol
methods if they:
•
Pub. No. C-354 EN
Version 2.0
HDIC DT
LDL cholesterol and VLDL cholesterol can be calculated from the results of the VITROS CHOL DT Slide, VITROS TRIG DT
Slide, and the results for HDL cholesterol to provide complete lipoprotein profiles.
LDL = CHOL-HDLC-VLDL
VLDL = TRIG/5 for conventional units (mg/dL)
VLDL = TRIG/2.2 for SI units (mmol/L)
Calculation of LDL is not appropriate for samples with triglyceride concentrations greater than 400 mg/dL (4.57 mmol/L) or with
samples from patients who have type III hyperlipoproteinemia (electrophoresis "broad beta" lipoprotein) present.12
Expected Results
These guidelines have been recommended by the National Institutes of Health.'3
Reference Interval for HDLC DT
SI Units
(mmol/L)
<1.0
>1.6
Conv. Units
(mg/dL)
<40
>60
Low
High
The VITROS DT60/DT60 II Chemistry System may be programmed to report HDL cholesterol results in conventional and
SI units.
Reporting Units and Unit Conversion for HDLC DT
Conventional Units
SI Units
mg/dL
Known Interferences
The VITROS DT Micro HDL Cholesterol Kit method was screened for interfering substances following NCCLS Protocol EP7."
The substances listed in the table, when tested at the concentrations indicated, caused the bias shown.
Known Interfering Substances for HDLC DT
Interferent
Interferent*
Ascorbic acid
Dipyrone
Dopamine
N-acetylcysteine
*
**
Concentration
Comments
3 mg/dL
170umol/L
High Therapeutic
12 mg/dL
3.6 mmol/L
High IV Drip
4 mg/dL
200 umol/L __ High IV Drip
10 mg/dL
0.61 mmol/L
Oral Therapeutic
HDL Cholesterol
Concentration
Conv.
(mg/dL)
40.9
40.5
44.6
40.2
SI
(mmol/L)
1.06
1.05
1.15
1.04
Bias**
Conv.
(mg/dL)
-7
-7
-9
-6
SI
(mmol/L)
-0.18
-0.18
-0.22
-0.14
The bias is an estimate of the maximum difference observed.
Other Limitations
Certain drugs and clinical conditions are known to alter HDL cholesterol concentration in vivo. For additional information, refer
to one of the published summaries.' 516 "
Version 2.0
Pub. No. C-354 EN
HD1CDT
Method Comparison
The plots and table show the results of a comparison of the VITROS HDL Cholesterol Method analyzed on the VITROS DT60 II
Chemistry System using the Dextran Sulfate/Enzymatic10 comparative method using pretreated serum specimens.
Method Comparison for HDLC DT: Serum
SI Units
Conventional Units
y =x
y =x
3.0
100
2.5
80
2.0
1.5
40
1.0
20
0.5
0.0
0
20
40
60
80
100
0.0
0.5
Comparative Method: Dextran Sulfate/Enzymatic (mg/dL)
1.0
1.5
2.0
2.5
3.0
Comparative Method: Dextran
Sulfate/Enzymatic (mmol/L)
n
DT60 II System vs.
comparative method
43
Correlation
Slope Coefficient
1.00
0.998
Range of
Sample Cone.
12-101
Intercept Sy.x
0.02
1.23
SI Units (mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
0.3-2.6
0.00
0.03
Precision
Precision for HDLC DT: Serum
System
VITROS DT60 II
Mean
Within
Within
Cone.
Day SD* Lab S D "
30.8
0.98
1.12
52.1
0.99
2.14
SI Units (mmol/L)
Within
Within
Mean
Day SD* Lab S D "
Cone.
0.03
0.03
0.80
1.35
0.03
0.06
Within
Lab
CV%**
No.
Observ.
3.7
92
23
4.1
91
23
No.
Days
Pub. No. C-354 EN
Version 2.0
HDLC DT
References
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Warnick GR, Benderson J, Albers JJ. Dextran Sulfate-Mg+2 Precipitation Procedure for Quantitation of High-Density Lipoprotein Cholesterol. In
Cooper GR (ed). Selected Methods of Clinical Chemistry. Washington, D.C.: American Association for Clinical Chemistry; 10:91-99; 1983.
NCCLS. Protection of Laboratory Workers from Instrument Biohazards and Infectious Diseases Transmitted by Blood, Body Fluids and Tissue;
Approved Guideline. NCCLS Document M29 (OSBN 1-56238). NCCLS, Wayne, PA 19087; 1997.
Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR Analyzer, and Evaluation of
"Plasma Separator Tubes (PST)." Clin. Chem. 35:151-153; 1989.
Recommendations for Improving Cholesterol Measurement: A Report from the Laboratory Standardization Panel of the National Education
Program. US Department of Health and Human Services Public Health Service, National Institutes of Health. NIH Publication No. 90-2964.
February 1990.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS; 1991.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS; 1991.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical Microscopy. Northfield, IL: College
of American Pathologists; 1992.
Warnick GR, Wood PD. National Cholesterol Education Program Recommendations for Measurements of High-Density Lipoprotein Cholesterol:
Executive Summary. Clin. Chem. (41)10:1427-1433; 1995.
Kimberley MM, Leary ET, Cole TG, Waymack PP. Selection, Validation, Standardization and Performance of a Designated Comparison Method
for HDL-Cholesterol for Use in the Cholesterol Reference Laboratory Network. Clin. Chem. (45) 10:1803-1812; 1999.
NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline-Second Edition. NCCLS
Document C24. Wayne, PA: NCCLS; 1999.
Friedewald WT, Levy Rl, Fredrickson DS. Estimation of the Concentration of Low-Density Lipoprotein Cholesterol in Plasma without Use of the
Preparative Ultracentrifuge. Clin. Chem. 18:499; 1972.
NCEP. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood
Cholesterol in Adults (Adult Treatment Panel III); Executive Summary. NIH Publication No. 01-3670. National Institutes of Health. Bethesda.
Maryland: May, 2001.
Tryding N, Tufvesson C, Sonntag O (eds). Drug Effects in Clinical Chemistry, ed. 7. Stockholm: The National Corporation of Swedish
NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. Wayne, PA: NCCLS; 1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Authorized Representative in
the European Community
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(Year-Month-Day)
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Serial Number
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REF
Catalog Number or
Product Code
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Manufacturer follows
packaging management
procedures
A
Attention: See
Store Between
ml
Manufacturer
Consult Instructions for Use
2
Version 2.0
Pub. No. C-354 EN
M
This end up
VITRCpS 0
HDLCDT
Revision History
Revision History
Date of
Revision
2004-02-29
Version
2.0
2003-08-11
1.0
> Slide Diagram - changed BaSO2 to BaSO4
> Method Comparison - replaced plots to show all available data
> Updated Glossary of Symbols table
> New format
<>
i>
Limitations of the Procedure - updated values for HDL cholesterol concentration
and bias in the Known Interferences table
> Method Comparison - updated comparison values and plots
4
\AAien this Instructions For Use is replaced, sign and date below and retain as specified by local regulations or laboratory
Signature
Obsolete Date
C€
Johnson & Johnson
50-100 Holmers Farm Way
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
10
company
All rights reserved.
Pub. No. C-354 EN
Version 2.0
VITRCpS
Chemistry I
HDLC DT
VITROS Chemistry Products DT HDL Cholesterol Kit
HDL Cholesterol
Intended Use
For use in the quantitative measurement of HDL cholesterol (HDLC) concentration in serum and plasma.
HDL cholesterol is used to evaluate the risk of developing coronary heart disease (CHD). The risk of CHD increases with
lower HDL cholesterol concentrations.
VITROS DT HDL Cholesterol Kit is used to prepare and test samples for high density lipoprotein (HDL) cholesterol on VITROS
DT60/DT60 II Chemistry Systems. The specimens must initially be treated with a reagent to remove other lipoproteins which
also contain cholesterol, including the very low density (VLDL) and low-density (LDL) classes. The amount of HDL cholesterol
can then be determined using VITROS Chemistry Products HDLC DT Slides.
HDL is separated by the precipitation of LDL and VLDL using dextran sulfate (MW 50,000) and magnesium chloride 1 that is
provided in the VITROS Chemistry Products HDL Tube. The HDL lipoproteins remain in the liquid portion of the tube after
centrifugation. This liquid portion is called the supernate and is the portion analyzed. The non-HDL fractions form a pellet on
the bottom of the tube and are discarded.
A drop of pretreated patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying
layers. The Triton X-100 (TX100) surfactant in the spreading layer aids in dissociating the cholesterol and cholesterol esters
from lipoprotein complexes present in the sample. Hydrolysis of the cholesterol esters to cholesterol is catalyzed by cholesterol
ester hydrolase. Free cholesterol is then oxidized in the presence of cholesterol oxidase to form cholestenone and hydrogen
The density of dye formed is proportional to the HDL cholesterol concentration present in the pretreated sample and is
measured by reflectance spectrophotometry.
Reaction Sequence
high density lipoproteins
Txioo
cholesterol oxidase
cholesterol + O2
peroxidase
H2O2 + leuco dye
>• cholesterol + fatty acids
— ^ cholest-4-en-3-one + H2O2
dye + 2H2O
Test Type and Conditions for HDLC DT
Test Type
Colori metric
Version 2.0
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Pub. No. C-341 EN
Temperature
37°C (98.6°F)
Wavelength
660 nm
Sample Drop
Volume
10 uL
HDLC DT
HDL Cholesterol
solid and liquid waste, and test components in accordance with local regulations and NCCLS Guideline M29 2 or other
While VITROS HDLC Sample Diluent product is bovine in origin, it should be handled using the same precautions as with any
other blood or blood-derived product.
For specific warnings and precautions for calibrators, quality control materials, and other components, refer to the Instructions
for Use for the appropriate VITROS product, or to other manufacturer's product literature.
WARNING:
VITROS HDL Tubes contain sodium azide. Disposal of reagent into sinks with
copper or lead plumbing should be followed with plenty of water to prevent
formation of potentially explosive metallic azides.
VITROS HDL Cholesterol Reagent contains sodium azide (0.01%; 0.01 g/dL). Disposal of reagent into sinks with copper or
lead plumbing should be followed with copious volumes of water to prevent formation of potentially explosive metallic azides.
First Aid
VITROS HDL Tubes contain gentamicin sulfate and sodium azide.
R22 - Harmful if swallowed.
•
•
•
•
Skin-Wash skin after each contact with soap and plenty of water for at least 15 minutes. Seek medical attention if skin is
cut or punctured.
Eye - Immediately flush eyes, including under the eyelids, with plenty of water for at least 15 minutes and get medical
attention.
Ingestion - Drink 1 -2 glasses of water. Seek medical advice.
Transportation
Reagents
Slide Diagram
HDLC DT Slide Ingredients
—
2
.
.
-
••-"*
*
z
Triton X-100 0.8 mg; cholesterol oxidase {Nocardia, E.C.1.1.3.6) 0.2 U;
cholesterol ester hydrolase (Candida rugosa, E.C.3.1.1.13) 0.7 U; peroxidase
(horseradish root, E.C.1.11.1.7) 5.3 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)4,5-bis-(4-dimethylaminophenyl) imidazole (leucodye) 0.2 mg.
Other ingredients
> Triton X-100
» cholesterol ester
hydrolase
» cholesterol oxidase
• peroxidase
» leuco dye
3. Sublayer
> buffer, pH 6.25
4. Support layer
HDL Tubes
Dextran sulfate (MW50,000) 0.8 mg, magnesium chloride hexahydrate 6.7 mg
Other ingredients
Sodium azide 0.22%, gentamicin sulfate <0.01%, dye and preservatives
2
Pub. No. C-341 EN
Version 2.0
HDLC DT
HDL Cholesterol
HDLC Sample Diluent
Bovine serum albumin 7%
Other ingredients
Sodium azide 0.05%, inorganic salts and preservatives
Slide Handling
Slide Preparation
IMPORTANT:
opened.
(64 "-82 °F) for >48 hours.
Kit Storage and Stability
VITROS DT HDL Cholesterol Kit components are stable until the expiration date on the carton when they are stored and
handled as specified.
Kit Storage and Stability for HDLC DT
Kit Component
Storage Condition
Stability
Slide
Refrigerated
Frozen
Room temperature
Room temperature
Opened
Tubes
Refrigerated
Frozen
2°-8°C (36°-46°F)
<-18°C(<0°F)
18°-28°C(64°-82°F)
18O-28°C(64°-82°F)
<48 hours
<15 minutes
2°-8°C (36°-46°F)
<-18°C(<0°F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
Sample Diluent*
•
Refrigerated
Frozen
* Discard if the solution becomes cloudy or turbid.
Verify performance with quality control materials:
- If the system is turned off for more than 2 hours.
•
•
Serum
Plasma:3
IMPORTANT:
Heparin
.
Version 2.0
Plasma:5
EDTA
Pub. No. C-341 EN
HDLCDT
HDL Cholesterol
Serum and Plasma
Patient Preparation
• No special patient preparation is necessary unless the HDL cholesterol test is part of a complete lipid profile. Then,
a 12- to 14-hour fast is necessary.1
Special Precautions
• Centrifuge specimens and remove the serum or plasma from the cellular material within 3 hours of collection. ° If further
processing is delayed, store in the refrigerator at 2°-8°C (36°-46°F).
- , • ' • ' ) (•••
•
•
Handle specimens as biohazardous material,
Specimen Storage and Stability for HDLC DT: Serum and Plasma '•*
Storage
Original Specimen
Refrigerated
Frozen
Pretreated Specimen (Supernate)
Temperature
Stability
2°-8°C (36°-46°F)
<-18°C(<0°F)
<3 days
<4 weeks*
<-20°C (<-4°F)
<-70°C (<-94°F)
<3 months
<2 years
Freezer
For longer storage, separate HDL fractions and freeze the supernate.
IMPORTANT:
Materials Provided
•
•
•
25 VITROS Chemistry Products HDLC DT Slides
27 VITROS Chemistry Products HDL Tubes
VITROS Chemistry Products HDLC Sample Diluent
•
•
.
•
•
VITROS Chemistry Products DT Controls I & II
VITROS DT Pipette
Centrifuge capable of generating forces of 1500 x g, or a microcentrifuge capable of generating forces of 12,600 x g
A vortex mixer is recommended
Special Precautions
•
Use a vortex speed that will not cause the mixture to spill out of the sample tube.
Procedure
IMPORTANT;
Do riot pretreat calibrators.
IMPORTANT;
1. Allow at least 10 minutes for refrigerated VITROS HDL Tubes and VITROS HDLC Sample Diluent to reach room
temperature. If these materials are stored at -18°C (0°F), they will require a longer warm-up period (at least 30 minutes).
Once opened, the VITROS HDLC Sample Diluent should be stored tightly capped in the refrigerator between uses.
2. Pipette serum or heparin plasma to the 0.5 mL mark on the VITROS HDL Tube.
3. Cap and mix thoroughly for 30 seconds - a vortex mixer is recommended.
NOTE:
4.
The sample will become cloudy during mixing.
Let stand for a minimum of 5 minutes.
Pub. No. C-341 EN
Version 2.0
HDLC DT
Calibration
HDL Cholesterol
5. Centrifuge the VITROS HDL Tube for 10 minutes at 1,500 x g. Alternatively, you may centrifuge the tube for a shorter
duration using a microcentrifuge for 95 seconds at 12,600 x g.
6. Visually check supemates for clarity. The non-HDL fractions form a pellet on the bottom of the tube. Do not disturb the
pellet. If the supernate is clear, transfer cleared supernate directly from the VITROS HDL Tube to a sample cup for analysis
on the DT analyzer.
IMPORTANT:
Supernates should be removed from the pelleted precipitate as soon as possible
following centrifugation. The supernates should be used within 15 minutes. If analysis
on the VITROS DT60/DT60 II Chemistry System is to be delayed more than one hour,
the supernate should be refrigerated. If analysis is delayed longer than 8 hours, refer
to the "Specimen Handling and Storage" section.
7. Analyze treated sample as instructed in the operator's manual for your VITROS DT60/DT60 II Chemistry System.
•
IMPORTANT:
immediately.
Sample Dilution
If HDL concentrations exceed the system's reportable (dynamic) range or if the supernatant is cloudy or has floating particles
after pretreatment:
1. Dilute the untreated sample with an equal volume of VITROS HDLC Sample Diluent.
2. Mix gently by inverting several times.
3. Pipette 0.5 mL of the diluted specimen into a second VITROS HDL Tube.
4. Repeat steps 1 through 6 of the procedure above. Remember to multiply the result by the dilution factor of 2.0.
5. Reanalyze.
6. Multiply the results by 2 to obtain an estimate of the original sample's HDL concentration.
MOTE;
Additional dilutions are not recommended.
Calibration
IMPORTANT:
When to Calibrate
Calibrate:
The VITROS HDLC DT slides may also need to be calibrated:
Version 2.0
Pub. No. C-341_EN
HDLCDT
HDL Cholesterol
Quality Control
Calculations
each slide lot, high-density lipoprotein cholesterol concentration in unknown samples can be determined using the softwareresident endpoint colorimetric math model and the response obtained from each unknown test slide.
a calibration.
Reportable (Dynamic) Range for HDLC DT
1-110
SI Units (mmol/L)
0.03-2.84
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for High Density Lipoprotein-Cholesterol (HDLC)
Reagent with VITROS HDLC DT Slides are traceable to the Certified NIST (National Institute of Standards and Technology)
Reference Material, SRM® (Standard Reference Material) 911b. The Ortho-Clinical Diagnostics Calibration Laboratory uses
SRM® 911b to assign values to secondary standards for calibration of an HDLC Selected Method. The Selected Method
supports VITROS HDL Cholesterol reagent value assignment for the VITROS DT Calibrator Kit. The HDLC Selected Method
includes (MW 50,000) Dextran Sulfate precipitation of non-HDL lipoproteins according to the recommendations of the Centers
for Disease Control (CDC), 10 followed by automated enzymatic determination of supernate (HDL fraction) cholesterol
concentration.
Quality Control
IMPORTANT:
Controls must be pretreated.
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition " or other published guidelines.
IMPORTANT;
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other HDL cholesterol
methods if they:
•
Pub. No. C-341 EN
Version 2.0
HDLC DT
HDL Cholesterol
LDL cholesterol and VLDL cholesterol can be calculated from the results of the VITROS CHOL DT Slide, VITROS TRIG DT
Slide, and the results for HDL cholesterol to provide complete lipoprotein profiles.
LDL = CHOL-HDLC-VLDL
VLDL = TRIG/5 for conventional units (mg/dL)
VLDL = TRIG/2.2 for SI units (mmol/L)
Calculation of LDL is not appropriate for samples with triglyceride concentrations greater than 400 mg/dL (4.57 mmol/L) or with
samples from patients who have type III hyperlipoproteinemia (electrophoresis "broad beta" lipoprotein) present. 12
Expected Results
These guidelines have been recommended by the National Institutes of Health. 13
Reference Interval for HDLC DT
Conv. Units
(mg/dL)
<40
>60
Low
High
SI Units
(mmol/L)
<1.0
>1.6
The VITROS DT60/DT60 II Chemistry System may be programmed to report HDL cholesterol results in conventional and SI
units.
Reporting Units and Unit Conversion for HDLC DT
Conventional Units
SI Units
mg/dL
Known Interferences
The VITROS DT HDL Cholesterol Kit method was screened for interfering substances following NCCLS Protocol EP7. " The
Known Interfering Substances for HDLC DT
HDL Cholesterol
Concentration
Interferent
Interferent*
Ascorbic acid
Dipyrone
Dopamine
N-acetylcysteine
*
**
Concentration
170umol/L
3 mg/dL
3.6 mmol/L
12 mg/dL
200 umol/L
4 mg/dL
0.61 mmol/L
10 mg/dL
Comments
High Therapeutic
High IV Drip
High IV Drip
Oral Therapeutic
Conv.
(mg/dL)
40.9
40.5
44.6
40.2
SI
(mmol/L)
1.06
1.05
1.15
1.04
Bias**
Conv.
(mg/dL)
-7
-7
-9
-6
SI
(mmol/L)
-0.18
-0.18
-0.22
-0.14
The bias is an estimate of the maximum difference observed.
Other Limitations
Certain drugs and clinical conditions are known to alter HDL cholesterol concentration in vivo. For additional information, refer
to one of the published summaries.1516'17
Version 2.0
Pub. No. C-341 EN
HDLCDT
HDL Cholesterol
Method Comparison
The plots and table show the results of a comparison of the VITROS HDL Cholesterol Method analyzed on the VITROS DT60 II
Chemistry System using the Dextran Sulfate/Enzymatic 10 comparative method using pretreated serum specimens. The
VITROS DT HDL Cholesterol method has met the requirements of the CDC/NCEP Lipid Standardization Program for
manufacturers.
SI Units
Conventional Units
y =x
y =x
3.0
- 100
I 2.5
1 80
E
I 2.0
I 60
g
40
o
s
20
» 1.5
I 0.5
5
0.0
0
0
20
40
60
80
100
0.0
0.5
Comparative Method: Dextran Sulfate/Enzymatic (mg/dL)
1.0
1.5
2.0
2.5
3.0
Comparative Method: Dextran
Sulfate/Enzymatic (mmol/L)
n
DT60 II System vs.
comparative method
43
Correlation
Slope Coefficient
1.00
0.998
Range of
Sample Cone.
12-101
Intercept Sy.x
0.02
1.23
SI Units (mmol/L)
Range of
Sample Cone. Intercept
0.3-2.6
Sy.x
0.00
0.03
Precision
Precision was evaluated with quality control materials on VITROS the DT60 II System following NCCLS Protocol EP5. 1S
Precision for HDLC DT: Serum
System
VITROS DT60 II
Mean
Within
Within
Cone.
Day SD* Lab SD**
31.5
0.56
1.01
2.14
53.8
0.90
SI Units (mmol/L)
Mean
Within
Within
Cone.
Day SD* Lab SD**
0.01
0.82
0.03
0.02
1.39
0.06
Within
Lab
CV%**
No.
Observ.
No.
Days
3.2
99
25
4.0
100
25
Pub. No. C-341_EN
Version 2.0
HDL6 DT
References
HDL Cholesterol
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
Warnick GR, Benderson J, Albers JJ. Dextran Sulfate-Mg+2 Precipitation Procedure for Quantitation of High-Density Lipoprotein Cholesterol. In
Cooper GR (ed). Selected Methods of Clinical Chemistry. Washington, D.C.: American Association for Clinical Chemistry, 10:91-99; 1983.
Doumas BT, et al. Differences Between Values for Plasma and Serum in Tests Performed in the Ektachem 700 XR Analyzer, and Evaluation of
"Plasma Separator Tubes (PST)." Clin. Chem. 35:151-153; 1989.
Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Education
Program. US Department of Health and Human Services Public Health Service, National Institutes of Health. NIH Publication No. 90-2964.
February 1990.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS; 1991.
NCCLS. Procedures for the Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS; 1991.
Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle VI: Chemistry/Clinical Microscopy. Northfield, IL: College
of American Pathologists; 1992.
Warnick GR, Wood PD. National Cholesterol Education Program Recommendations for Measurements of High-Density Lipoprotein Cholesterol:
Executive Summary. Clin. Chem. (41)10:1427-1433; 1995.
NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline-Second Edition. NCCLS
Document C24. Wayne, PA: NCCLS; 1999.
Friedewald WT, Levy Rl, Fredrickson DS. Estimation of the Concentration of Low-Density Lipoprotein Cholesterol in Plasma without Use of the
Preparative Ultracentrifuge. Clin. Chem. 18:499; 1972.
NCEP. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood
Cholesterol in Adults (Adult Treatment Panel III); Executive Summary. NIH Publication No. 01-3670. National Institutes of Health. Bethesda.
Maryland: May, 2001.
Tryding N, Tufvesson C, Sonntag O (eds). Drug Effects in Clinical Chemistry, ed. 7. Stockholm: The National Corporation of Swedish
NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. Wayne, PA: NCCLS; 1992.
Glossary of Symbols
Glossary of Symbols
Version 2.0
I
t
Do Not Reuse
Date
(Year-Month-Day)
Tests
Lot Number
Device
This end up
SN
Serial Number
Store At or Below
Irritant
REF
Catalog Number or
Product Code
Store At or Above
procedures
Attention: See
Store Between
Manufacturer
Pub. No. C-341 EN
Keep Dry
VITRCflS 0
HDICDT
HDL Cholesterol
Revision History
Revision History
Date of
Revision
2004-02-29
Version
2.0
2003-08-11
1.0
> Slide Diagram - changed BaSO2 to BaSO,
• Method Comparison - added that method meets requirements of CDC/NCEP
Lipid Standardization Program for manufacturers, replaced plots to show all
available data
> Updated Glossary of Symbols table
• New format
> Limitations of the Procedure - updated values for HDL cholesterol concentration
and bias in the Known Interferences table
• Method Comparison - updated comparison values and plots
Signature
Obsolete Date
C€
EC
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
10
Pub. No. C-341 EN
Version 2.0
I Product*
VITRII3S
Chemistry!
K DT
VITROS Chemistry Products K+ DT Slides
Potassium
Intended Use
VITROS K* DT Slides quantitatively measure potassium (K+) concentration in serum and plasma.
Potassium is the major cation of the intracellular fluid. Measurement of serum potassium is used for evaluation of electrolyte
imbalance, cardiac arrhythmias, muscular weakness, hepatic encephalopathy, and renal failure and for the monitoring of
ketoacidosis in diabetes mellitus and intravenous fluid replacement therapy.
More than 90% of hypertensive patients with aldosteronism have a low K+; a low K* is also common in vomiting, diarrhea,
alcoholism, and folic acid deficiency. High K* values occur in rapid K+ infusion, end stage renal failure, hemolysis, trauma,
Addison's disease, metabolic acidosis, acute starvation, dehydration, and acute medical emergency.
The VITROS IC DT Slide method is performed using the VITROS K+ DT Slide and the VITROS Chemistry Products
The VITROS K+ DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry for
measurement of ionic potassium. The slide consists of two ion-selective electrodes, each containing valinomycin (an ionophore
for potassium), a reference layer, and a silver and a silver chloride layer coated on a polyester support.
Each electrode produces an electrical potential in response to the activity of potassium applied to it. The potential difference
poised between the two electrodes is proportional to the potassium concentration in the sample.
Test Type and Conditions for K*
Test Type
Potentiometric
VITROS DT60/DT60 II
Module
DTE/DTE II
90 or 180 seconds*
Temperature
25°C (77°F)
Drop Volume
Reference
Sample:
Fluid: 10 uL
10 ML
Assay time is determined by the Calibration Data Module (CDM).
Version 1.0
Pub. No. C-306
K DT
Potassium
Reagents
Reagents
Slide Diagram
Slide Ingredients
2
Silver 0.4 mg; silver chloride 0.2 mg; potassium chloride 63 (.ig; and
valinomycin 55 \xg.
*3
.
. . - - "" *
Other ingredients
Binders, plasticizers, stabilizer, surfactants and nickel.
1. Upper frame
2. Paper Bridge
3. Ion-selective
membrane
• valinomycin
4. Reference layer
• KCI
6. Silver, silver chloride
layer
6. Support layer
7. Lower frame
7
Slide Handling
Slide Preparation
fMPQRTANT:
The slide must reach room temperature, 18o-28aC(64o-82°F),
opened.
before the wrapper is
(64 °-82°F) for >48 hours.
1.
2.
VITROS K* DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and S t a b i l i t y f o r K D T
Slides
Unopened
Storage Condition
3
Room temperature
18°-28 C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28 'C (64°-82° F)
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
Serum
Plasma:2
IMPORTANT:
Heparin
•
•
Plasma:5
EDTA
Citrate
Fluoride oxalate
Do not use hemolyzed specimens. Lysis of only 0.5% of the erythrocytes can increase potassium levels by 0.5 mmol/L.4
Pub. No. C-306
Version 1.0
K DT
Testing Procedure
Potassium
Serum and Plasma
Patient Preparation
The patient should avoid any exercise of the arm or hand before or during collection because opening and closing the fist
increases potassium concentration by 10% to 20%.4
Special Precautions
• Do not refrigerate the specimen prior to centrifugation because potassium will leak from the red blood cells.6
•
Centrifuge specimens and remove the serum or plasma from the cellular material within 2 hours of collection.5
"
•
•
<:
Storage
Specimen Storage and Stability for K* DT: Serum and Plasma 5
Temperature
Storage
Stability
Room temperature
18°-28°C(64°-82°F)
<6 weeks
2°-8°C (36°-46°F)
<6 weeks
Refrigerated
Frozen
<-18°C (<0°F)
<1 year
Testing Procedure
Materials Provided
•
VITROS Chemistry Products K* DT Slides
•
•
•
•
.
VITROS DTE Pipette
•
I
I
IMPORTANT:
Bring all fluids and samples to room temperature, 18°-28°C (64°-82"F), prior to
analysis.
Sample Dilution
Potassium concentrations outside the reportable (dynamic) range are not expected. Diluted samples should not be analyzed
with VITROS K* Slides because dilution changes the concentration of solids in plasma water and the ionic strength of the
sample.
Version 1.0
Pub. No. C-306
KDT
Potassium
Calibration
Calibration
NOTE:
Calibrate potassium in duplicate by running each bottle twice.
When to Calibrate
Calibrate:
The VITROS K' DT test may also need to be calibrated:
Calculations
The analyzer measures the potential difference in millivolts between the two electrodes of a potentiometric slide—one in
contact with the sample to be analyzed and the other in contact with the electrolyte reference fluid. A linear relationship exists
between the measured potential difference observed on the slide and the logarithm of potassium concentration, i.e. the Nernst
equation for ion-selective electrodes. Once the calibration has been established for each slide lot, unknown potassium
concentration for a given sample can be determined using the software-resident math model and the measured potential
difference.
a calibration.
Reportable (Dynamic) Range for K* DT
1.0-11.0
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for potassium are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM" (Standard Reference Material) 918a. The OrthoClinical Diagnostics calibration laboratory uses SRM 918a to calibrate the flame atomic emission spectroscopy method9 to
support potassium value assignment for the VITROS DT Calibrator Kit.
Pub. No. C-306
Version 1.0
K DT
Quality Control
Potassium
Quality Control
|
•
•
•
•
•
•
System.
I
IMPORTANT;
•
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other potassium
methods if they:
The serum reference interval is based on an external study.11
The plasma reference interval is based on an external study.4
Reference Interval for K+
Serum
3.5-5.1 mmol/L
Plasma
0.1-0.7 mmol/L lower than serum range
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report potassium results in conventional units.
Reporting Units for K+ DT
mmol/L
Known Interferences
None have been identified.
Other Limitations
Certain drugs and clinical conditions are known to alter potassium concentration in vivo. For additional information, refer to one
of the published summaries.12 13
Version 1.0
Pub. No. C-306
K DT
Potassium
Method Comparison
I
The plot and table show the results of a comparison of the VITROS DT60 II Chemistry System with the VITROS 950 Chemistry
System. Testing followed NCCLS Protocol EP9.14
The table also shows the results of comparisons of the VITROS K* DT slide at an assay time of approximately 90 seconds with
the VITROS K* DT slide at an assay time of approximately 180 seconds.
Method Comparison for K+ DT: Serum
12
5
IO •
-
8"
I
to
,.
ft
2
4
6
8
12
10
(mmol/L)
Method Comparison for K* DT: Serum
(mmol/L)
Range of
Sample Cone. Intercept Sy.x
n
Slope
Correlation
Coefficient
DT60/DT60 II System vs.
950 System
35
1.02
0.999
1.8-7.5
-0.20
0.06
90 seconds vs.
180 seconds
35
1.02
1.000
1.6-7.3
-0.04
0.04
Precision
Precision for K+ DT: Serum
System
VITROS DT60 II
Mean Cone.
2.4
5.3
0.02
0.07
No. Observ.
No. Days
0.04
1.5
88
22
0.09
1.7
88
22
Pub.
No. C-306
Version 1.0
KOT
Potassium
References
References
1.
1991.
1991.
Slockbower JM, Blumenfeld TA (ed.). Collection and Handling of Laboratory Specimens. Philadelphia: Lippincott Co; 201; 1983.
9. Velapoldi R.A., et al. A reference method for the determination of potassium in serum. National Institute of Standards and Technology
Special Publication 260-63. Gaithersburg, MD, 1978.
11. Tietz NW (ed). Fundamentals of Clinical Chemistry, ed. 4. Philadelphia: WB Saunders; 809; 1996.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Manufacturer
Store Between
Use
Lot Number
Tests
Care.
Number
Keep Dry
Store At or Below
This end up
Do Not Reuse
_
Date (YYYY-MM-DD)
Catalog Number or
Product Code
Attention: See
Version 1.0
s-e I ma*
X
1
Store At or Above
Pub. No. C-306
KDT
Potassium
Revision History
Revision History
Date of
'Revision
2003-03-28
Version
1.0
« New format
> Specimens Not Recommended - added citrate and fluoride oxalate
> Patient Preparation - updated
> Special Precautions - updated
• Specimen Storage and Stability - updated stability values
• Quality Control Material Selection - added the statement regarding ethylene
glycol
« Expected Values and Reporting Units - updated values
• Reference Interval - updated values
Obsolete Date
Signature
C€
EC
Mandeville House
62 The Broadway
Amersham
England
' Otto-Clinical Diagnostics
aH company
Pub. No. C-306
Version 1.0
Chcmbtry
1ACDT
VITROS Chemistry Products LAC DT Slides
Lactate
Intended Use
VITROS LAC DT Slides quantitatively measure lactate (LAC) concentration in plasma.
Lactate is the end product of the anaerobic metabolism of glucose. The concentration of lactate in the blood is dependent on
the rate of production in muscle cells and erythrocytes and the rate of metabolism in the liver. Lactic acidosis usually results
from overproduction or underutilization of lactate. Elevated lactate levels can occur as a result of tissue hypoxia; diabetes
mellitus; phenformin therapy; malignancies; glycogen storage disease; ethanol, methanol, or salicylate ingestion; and metabolic
acidosis.1
The VITROS LAC DT Slide method is performed using the VITROS LAC DT Slide and the VITROS Chemistry Products
The VITROS LAC DT Slide is a multilayered, analytical element coated on a polyester support.
Lactate in the sample is oxidized by lactate oxidase to pyruvate and hydrogen peroxide. The hydrogen peroxide generated
oxidizes the 4-aminoantipyrine, 1,7-dihydroxynaphthalene dye system in a horseradish-peroxidase-catalyzed reaction and
results in a dye complex. The slide is incubated and the intensity of the dye complex is measured spectrophotometrically.
Reaction Sequence
L-(+)-lactic acid + O2 •
lactate oxidase
->•
pyruvate + H2O2
2H2O2 + 4-aminoantipyrine + 1,7-dihydroxynaphthalene
peroxidase
red dye
Test Type and Conditions for LAC DT
Test Type
Colorimetric
I
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-357
LACDT
Reagents
Lactate
Reagents
Slide Diagram
Slide Ingredients
2
I
, 2
Lactate oxidase (Pediococcus sp., E.C.1.1.3.2) 0.3 U; peroxidase (horseradish
" ' ''
root, E.C.1.11.1.7) 1.5 U; 1,7-dihydroxynapthalene (dye precursor) 43 ug; and
4-aminoantipyrine hydrochloride (dye precursor) 65 ug.
- - *
.
Other ingredients
4
~*~~
-
3. Reagent layer
• lactate oxidase
• peroxidase
• dye precursors
• buffer, pH 6.25
4. Support layer
S
Pigment, binders, buffer, stabilizers, cross-linking agent, surfactants and
enzyme cofactor.
Slide Handling
Slide Preparation
The slide must reach room temperature, 18°-28°C (64 °-82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 78°-28<C
(64 °-82 °F) for >48 hours.
1.
2.
VITROS LAC DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for LAC DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
WARN I M(k
•
•
Plasma:3
Fluoride oxalate
Heparinized plasma is acceptable, but precautions must be taken to retard glycoiysis by keeping the whole blood on ice."
IMPORTANT:
Plasma
•
Patient Preparation
• Venous specimens should be obtained without the use of a tourniquet or immediately after the tourniquet is applied.
Alternatively, the tourniquet should be removed after the puncture has been performed, and the blood should be allowed to
circulate for several minutes before the sample is withdrawn.4
• The patient should avoid any exercise of the arm or hand before or during collection of the specimen.4
Pub. No. C-357
Version 1.0
LAC DT
Testing Procedure
Lactate
Special Precautions
• For fluoride oxalate plasma, specimens must be collected in tubes that are at least half full. Smaller volume's can result in
negative biases.
• Centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection.3
Storage
•
•
Specimen Storage and Stability for LAC DT: Plasma3
Storage
Temperature
Room temperature
Refrigerated
Frozen
18O-28°C(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<8 hours
<14days
<1 month
Testing Procedure
Materials Provided
•
VITROS Chemistry Products LAC DT Slides
•
•
•
.
VITROS DT Pipette
•
IMPORTANT:
Bring all fluids and samples to room temperature, 18°-28°C (64°-82'F), prior to
analysis.
Sample Dilution
If lactate concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's lactate concentration.
Calibration
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-357
LACDT
Lactate
Quality Control
The VITROS LAC DT test may also need to be calibrated:
Calculations
each slide lot, lactate concentration in unknown samples can be determined using the software-resident endpoint colorimetric
a calibration.
Reportable (Dynamic) Range for LAC DT
0.5-12.0
I
|
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for lactate are traceable to gravimetrically prepared
standards made from reagent grade lactic acid. The Ortho-Clinical Diagnostics calibration laboratory uses the gravimetrically
prepared standard to calibrate an HPLC method for lactate8 to support value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
V ' A R ui Nc:
•
•
•
System.
•
•
•
I
I
IMPORTANT;
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other lactate methods
if they:
•
Pub.
No. C-357
Version 1.0
UCDT
Lactate
Reference Interval
This reference interval is the central 95% of results from a study of 168 apparently healthy adults from a working population.
The values for heparinized plasma may be higher because lactate rapidly increases in blood as a result of glycolysis.10
Reference Interval for LAC DT
0.7-2.1
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report lactate results in conventional and SI units.
Reporting Units for LAC DT
mmol/L
Known Interferences
None identified.
Other Limitations
Certain drugs and clinical conditions are known to alter lactate concentration in vivo. For additional information, refer to one of
the published summaries.1112
Method Comparison
I
I
using the VITROS 950 System.
Method Comparison for LAC DT: Plasma
12
I
Hi-
E
I
8-j
=
6
&
o
o
,j
4-
a:
2
4
6
8
10
(mmol/L)
Method Comparison for LAC DT: Plasma
Conventional and SIUnits (mmol/L)
DT60 II System vs.
950 System
Version 1.0
n
Slope
Intercept
Sy.x
58
1.00
1.000
0.8-10.3
0.01
0.08
Pub.
No. C-357
1ACDT
References
Lactate
Precision
Precision for LAC DT: Plasma
System
VITROS DT60 II
Mean Cone.
Within Day SD*
Within Lab SD**
Within Lab CV%**
No. Observ.
No. Days
1.6
0.02
0.03
1.6
84
21
4.0
0.04
0.06
1.6
83
21
References
1.
2.
Oliva PB. Am. J. Med. 48:209-225; 1970.
1991.
1991.
8. Smith JW, Ambrose RT. Determination of Lactic Acid in Human Serum by Ion Exchange Chromatography. Internal Eastman Kodak
Company Report. 1982.
1992.
Pub. No. C-357
Version 1.0
gj VITFIJ
IACDT
Lactate
Glossary of Symbols
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date (YYYY-MM-DD)
ee I KEI> I
Manufacturer
Store Between
Use
Lot Number
Tests
SN
Number
REF|
Catalog Number or
Product Code
Store At or Below
Attention: See
X
I
Care.
Keep Dry
M
This end up
Store At or Above
Revision History
Date of
Revision
2003-10-01
Version
1.0
> New format
« Test Type and Conditions - updated the wavelength
> Reference Interval - updated text
> Method comparison - updated all data and the plot
> References - added all except 1,10
Signature
Version 1.0
Obsolete Date
Pub. No. C-357
LACDT
Revision History
Lactate
C€
EC I REP
ill
Mandeville House
62 The Broadway
Amersham
England
company
Pub. No. C-357
Version 1.0
[ Prod wets;
ViTRCpS
Cbemittryl
LDHDT
VITROS Chemistry Products LDH DT Slides
Intended Use
VITROS LDH DT Slides quantitatively measure lactate dehydrogenase (LDH) activity in serum and plasma.
Lactate dehydrogenase is an enzyme present in the cytosol of all human cells; it catalyzes the reversible reduction of pyruvate
to lactate using NADH. Causes of high LDH include neoplastic states, hypoxic cardiorespiratory diseases, myocardial
infarctions, hemolytic anemias, megaloblastic anemias, hepatic cirrhosis, renal infarction, trauma, muscle damage, muscular
dystrophy, shock, and hypotension. In myocardial infarction cases, LDH begins to rise within about 12 hours after infarction and
usually returns to normal after two to five days.1
The VITROS LDH DT Slide method is performed using the VITROS LDH DT Slide and the VITROS Chemistry Products
The VITROS LDH DT Slide is a multilayered, analytical element coated on a polyester support.
Lactate dehydrogenase catalyzes the conversion of pyruvate and NADH to lactate and NAD+. The oxidation of NADH, which is
monitored by reflectance spectrophotometry, is used to measure lactate dehydrogenase activity.
Reaction Sequence
pyruvate + NADH + H+
LDH
- > • lactate + NAD+
Test Type and Conditions for LDH DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
340 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-344
LDHDT
Reagents
Reagents
Slide Diagram
Slide Ingredients
• sodium pyruvate
3. Reagent layer
• buffer, pH 7.25
• NADH
4. Support layer
2
Nicotinamide adenine dinucleotide, reduced 44 ug and sodium pyruvate 17 ug.
Other ingredients
Polymer beads, binders, buffer, surfactants, cross-linking agent and stabilizer.
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 78-28 £ C (64°-82°F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18°-28 °C
(64°-82°F) for >48 hours.
1.
2.
VITROS LDH DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for LDH DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
WARMS:
I
•
•
Serum
Plasma:3
NOTE:
Heparin
Serum and heparin plasma specimens produce similar LDH results on VITROS
Systems. Some other methods, however, have shown substantial differences between
serum and plasma results due to contamination by platelets in plasma separated by
low-speed centrlfugation.'1 The VITROS LDH DT Slide is insensitive to LDH contained
within intact platelets;5 therefore, LDH results in comparative methods may not agree
with the VITROS System results for heparin plasma specimens.
•
Do not use hemolyzed specimens.17
Pub. No. C-344
Version 1.0
|Sj VITRj
IDH DT
Testing Procedure
Serum and Plasma
Collect specimens using standard laboratory procedures.8'9
Patient Preparation
Special Precautions
• Centrifuge specimens and remove the serum from the cellular material within 1 hour of collection.10
G:
Specimen Storage and Stability for LDH DT: Serum and Plasma1
Storage
Room temperature
Refrigerated
Frozen
Temperature
18O-28°C(64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<2 days
Not recommended*
Not recommended*
* LD4 and LD5 isoenzymes are labile at refrigerator and freezer temperatures.
Testing Procedure
Materials Provided
•
VITROS Chemistry Products LDH DT Slides
•
•
•
.
VITROS DT Pipette
•
I
MPORTANT;
analysis.
Sample Dilution
If lactate dehydrogenase activities exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's lactate dehydrogenase activity.
|
Calibration
Version 1.0
Pub. No. C-344
1DHDT
Quality Control
When to Calibrate
Calibrate:
The VITROS LDH DT test may also need to be calibrated:
Calculations
activity. Once a calibration has been performed for each slide lot, lactate dehydrogenase activity in unknown samples can be
a calibration.
Reportable (Dynamic) Range for LDH DT
100-1750
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for lactate dehydrogenase are traceable to the pyruvateto-lactate (P->L) (Buhl) total lactate dehydrogenase method,12 adapted to a centrifugal analyzer at 37°C.
Quality Control
|
•
•
•
•
•
•
System.
Pub. No. C-344
Version 1.0
LDH DT
IMPORTANT;
I
•
|
I
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other lactate
dehydrogenase methods if they:
Reference Interval
These reference intervals are the central 95% of results from an internal study of 557 apparently healthy individuals.
Reference Interval for LDH DT
313-618
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report lactate dehydrogenase results in conventional
and SI units.
Reporting Units for LDH DT
U/L
Known Interferences
None identified.
Other Limitations
•
Version 1.0
Certain drugs and clinical conditions are known to alter lactate dehydrogenase activity in vivo. For additional information,
Pub. No. C-344
LDHDT
Method Comparison
I
Method Comparison for LDH OT: Serum
2000 •
„
1600
I
1200
800
400
400
1200
800
1600
2000
(U/L)
Method Comparison for LDH DT: Serum
DT60 II System vs.
9S0 System
n
Slope
Intercept
Sy.x
61
1.03
0.999
122-1418
-13.36
14.94
Precision
Precision for LDH DT: Serum
System
VITROS DT60 II
Mean Activity
Within Day SD*
Within Lab S D " Within Lab CV%** No. Observ.
458
6.2
7.5
1.6
1369
20.9
23.8
1.7
No. Days
84
21
84
21
Pub. No. C-344
Version 1.0
LDHDT
References
References
1.
2.
6.
7.
8.
Peake MJ, et al. Mechanism of Platelet Interference with Measurement of Lactate Dehydrogenase Activity in Plasma. Clin. .Chem.
30:518-520; 1984.
Greenberg N, Byrne D. Plasma Lactate Dehydrogenase Activity Assayed with the Kodak Ektachem 700 Analyzer Is Unaffected by
Platelet Contamination. Clin. Chem. 31:1022; 1985.
Young DS. Effects of Preanalytical Variables on Clinical Laboratory Tests. Ed. 2. Washington D C : AACC Press; 3-335, 1997.
9.
3.
4.
5.
1991.
1991.
10.
11. Tietz NW. Tietz Textbook of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 671; 1999.
12. Buhl SN, Jackson KY, Graffunder B. Optimal Reaction Conditions for Assaying Human Lactate Dehydrogenase Pyruvate-to-Lactate
at 20, 30, and 37°C. Clin. Chem. 24:261-266; 1978.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Date (YYYY-MM-DD)
Version 1.0
<sc wa» I
Pub. No. C-344
1DHDT
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
New format
and ethylene glycol
• Limitations of the Procedure - removed the statement regarding elevated total
protein levels
•
•
•
Signature
Obsolete Date
Mandeville House
62 The Broadway
Amersham
England
oH company
Pub. No. C-344
Version 1.0
Products
Chemistry
UDT
VITROS Chemistry Products Li DT Slides
Lithium
Intended Use
VITROS Li DT Slides quantitatively measure lithium (Li) concentration in serum and plasma.
Lithium is used in the treatment of bipolar (manic-depressive) illness. Lithium measurements are used to monitor patient
compliance and therapy and to diagnose potential overdose. Symptoms of lithium intoxication include sluggishness,
drowsiness, muscle weakness, and ataxia.'2
The VITROS Li DT Slide method is performed using the VITROS Li DT Slide and the VITROS Chemistry Products
DT Specialty Calibrator Kit on VITROS DT60 II Chemistry Systems.
The VITROS Li DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying
layers. The lithium in the sample is specifically bound by the crown-ether azo dye (6-dodecyl-6-(2'-hydroxy5'-(2"-4"-dinitrophenylazo)benzyl)-13, 13-dimethyl-1,4, 8,11-tetraoxacyclotetradecane). As the lithium ion binds to
the crownether, a shift in the peak absorbance of the dye occurs. The increase in absorbance is proportional to the concentration of
lithium in the sample. The intensity of the dye is measured by reflectance spectrophotometry at the end of incubation.
Reaction Sequence
dye complex
lithium + crown-ether dye
Test Type and Conditions for Li DT
Test Type
Colorimetric
VITROS DT60 II
Module
DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
630 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-372
UDT
Lithium
Reagents
Reagents
Slide Diagram
Slide Ingredients
—
-- ~~
(6-dodecyl-6-(2'-hydroxy-5'-(2"-4"-dinitrophenylazo)benzyl)-13,13-dimethyl1,4,8,11-tetraoxacyclotetradecane) (crown-ether azo dye) 40 pg.
Other ingredients
Pigment, binders, buffer, surfactants, dye solubilizer and cross-linking agent.
2. Spreading layer (BaSC>4)
• buffer, pH 11.0
3. Buffer layer
• buffer, pH 11.0
4. Reagent layer
• crowvether azo dye
S. Support layer
_- - - — *
Slide Handling
CAUTION;
Slide Preparation
IMPORTANT:
opened.
(64°-82°F) for >48 hours.
1.
2.
VITROS Li DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for Li DT
Slides
Storage Condition
Unopened
Room temperature
Refrigerated
Frozen
Room temperature
Opened
18°-28°C(64°-82° F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
18°-28°C(64°-82 O F)
Stability
<48 hours
<15 minutes
WA
•
•
Serum
Plasma:
EDTA
Heparin
MPORTANT:
•
Plasma:
Fluoride oxalate
Lithium heparin
Serum and Plasma
Pub. No. C-372
Version 1.0
[3 N/ITFJCp'S
Li DT
Testing Procedure
Lithium
Patient Preparation
Special Precautions
• Samples are commonly drawn approximately 12 hours after the last dose of lithium has been taken.7
WARNING;
•
•
Specimen Storage and Stability for Li DT: Serum and Plasma
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<8 hours
<24 hours
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products Li DT Slides
•
•
•
•
.
Reagent-grade water
VITROS DT Pipette
•
I
I
IMPORTANT:
Bring all fluids and samples to room temperature, 18°-28"C (64°-82°F), prior to
analysis.
Sample Dilution
If lithium concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's lithium concentration.
|
Calibration
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-372
LiDT
Lithium
Quality Control
The VITROS Li DT test may also need to be calibrated:
Calculations
each slide lot, lithium concentration in unknown samples can be determined using the software-resident endpoint colorimetric
Calibration parameters are automatically assessed by the VITROS DT60II Chemistry System against a set of quality
a calibration.
Reportable (Dynamic) Range for Li DT
0.2-4.0
Values assigned to the VITROS Chemistry Products DT Specialty Calibrator Kit for lithium are traceable to the Certified
NIST (National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 924a. The
Ortho-Clinical Diagnostics calibration laboratory uses SRM® 924a to calibrate the flame atomic absorption spectroscopy
method9 to support lithium value assignment for the VITROS DT Specialty Calibrator Kit.
Quality Control
j
WARNING;
•
•
•
•
•
•
- After specified service procedures are performed. Refer to the operator's manual for your VITROS DT60II System.
I
IMPORTANT:
I
•
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other lithium methods if
they:
Pub. No. C-372
Version 1.0
[3 VITQCpS
UDT
Lithium
Reference Interval
These serum lithium concentrations are based on the 12-hour standardized concentration, measured on a serum sample
obtained 12 hours after the last dose.11 12
Reference Interval for Li DT
0.6-1.2
Therapeutic 1 3
Toxic 14
Potentially
Severely
>1.5
>2.5
The VITROS DT60 II Chemistry System may be programmed to report lithium results in conventional and SI units.
Reporting Units for Li DT
mmol/L
Known Interferences
The VITROS Li DT Slide method was screened for interfering substances following NCCLS Protocol EP7.15 The substances
Known Interfering Substances for Li DT
Interferent*
Methyl para ben**
A/-Acetylcysteine
Hemoglobin
*
**
Interferent
Concentration
150mg/dL
180mg/dL
100mg/dL
250 mg/dL
500 mg/dL
(10 mmol/L)
(11.0 mmol/L)
(15.5 umol/L)
(38.8 umol/L)
(77.5 umol/L)
Lithium Concentration
Conv./SI Units
(mmol/L)
1.0
1.0
1.2
1.2
1.2
Average Bias
Conv./SI Units
(mmol/L)
-0.17
-0.15
+0.04
+0.12
+0.17
A preservative found in some controls, proficiency fluids, and sterile saline flushes
Other Limitations
Certain drugs and clinical conditions are known to alter lithium concentration in vivo. For additional information, refer to one of
the published summaries.16'17
Version 1.0
Pub. No. C-372
UDT
Lithium
Method Comparison
I
Method Comparison for Li DT: Serum
y =x
(mmol/L)
Method Comparison for Li DT: Serum
(mmol/L)
n
DT60 II System vs.
950 System
Correlation
Slope Coefficient
62
1.01
0.998
Range of
Sample Cone.
Intercept
Sy.x
0.2-3.9
-0.06
0.05
Precision
Precision for Li DT: Serum
System
VITROS DT60 II
Mean Cone.
No. Observ.
No. Days
1.2
0.02
0.04
3.2
84
21
2.4
0.04
0.05
2.1
83
21
Pub. No. C-372
Version 1.0
g] VITRI
LiDT
References
Lithium
References
1.
2.
Cade JFJ. Lithium Salts in the Treatment of Psychotic Excitement. Med. J. Aust. 2:349; 1949.
Baastrup PC, Schou M. Lithium as a Prophylactic Agent: Its Effect against Recurrent Depressions and Manic-Depressive Psychosis.
Arch. Gen. Psychiat. 16:162; 1967.
3. NCCLS. Protection of Laboratory Workers from Instrument Biohazards and Infectious Diseases Transmitted by Blood, Body Fluids and
4.
1991.
1991.
8. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle IV: Therapeutic Drug Monitoring/Toxicology.
Skokie, IL: College of American Pathologists; 1985.
9. Levy AL, Katz EM. A Comparison of Serum Lithium Determinations Using Flame Photometry and Atomic Absorption
Spectrophotometry. Clin. Chem. 15:787; 1969.
11. Gilman AG et al. Goodman and Gilman's The Pharmacological Basis of Therapeutics, ed. 8. 418-422; 1990.
12. Ellenhorn MJ, Barceloux DG. Medical Toxicology: Diagnosis and Treatment of Human Poisoning. New York: Elsevier; 1042-1045;
1988.
13. Burtis CA, Ashwood ER, (eds) Fundamentals of Clinical Chemistry, ed. 5. Philadelphia: WB Saunders; 1023; 2001.
14. Burtis CA, Ashwood ER, (eds) Fundamentals of Clinical Chemistry, ed. 5. Philadelphia: WB Saunders; 632; 2001.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Date (YYYY-MM-DD)
Lot Number
REF
Version 1.0
| EC | REP j
\2)/
V
Pub. No. C-372
LiDT
Lithium
Revision History
Revision History
Date of
Revision
2003-08-11
Version
1.0
New format
Specimens Not Recommended - added section
Sample Dilution - replaced isotonic saline and distilled water with
VITROS 7% BSA and reagent-grade water
• Known Interferences - updated values for hemoglobin
• References - added all except 1, 2,11,12,16,17,18
•
•
•
•
•
Signature
Obsolete Date
C€
I EC
REP I
Mandeville House
62 The Broadway
Amersham
England
»ftwm company
Pub. No. C-372
Version 1.0
Chemistry
LIPA DT
VITROS Chemistry Products LIPA DT Slides
Lipase
Intended Use
VITROS LIPA DT Slides quantitatively measure lipase (LIPA) activity in serum and plasma.
Lipase is a digestive enzyme that is mainly produced by the acinar cells of the exocrine pancreas. Its physiological role is to
hydrolyze the long-chain triglycerides in the small intestine. Serum lipase increases rapidly in patients with acute and recurrent
pancreatitis, pancreatic abscess or pseudocyst, pancreatic trauma, pancreatic cancer, common-bile-duct obstruction, and
ingestion of drugs that are toxic to the pancreas. It is also increased by most inflammatory conditions in the abdominal cavity,
biliary tract disease, abdominal abscesses, and renal failure. Lipase is more specific than total amylase in the diagnosis of
acute pancreatitis.1
The VITROS LIPA DT Slide method is performed using the VITROS LIPA DT Slide and the VITROS Chemistry Products
The VITROS LIPA DT Slide is a multilayered, analytical element coated on a polyester support. The analysis is based on an
enzymatic method described by Mauck.2
method incorporates colipase which facilitates the adsorption of lipase to the substrate micelles in the presence of bile salts.
Lipase then catalyzes the hydrolysis of water-insoluble triacylglycerol esters. The method uses the enzyme diacetinase to
convert the substrate 2,3-diacetylglycerol to glycerol. Glycerol kinase converts the glycerol to L-a-glycerophosphate.
L-a-glycerophosphate oxidase catalyzes the oxidation of L-a-glycerophosphate to generate hydrogen peroxide. Peroxidase
oxidizes a leuco dye to produce a colored dye. The rate of change in reflection density is proportional to the activity of lipase
present in the sample.
Reaction Sequence
lipase, colipase
pH8.5
1 -oleoyl-2,3-diacetylglycerol
diacetinase
2,3-diacetylglycerol
glycerol kinase
MgCI2
glycerol + ATP
glycerol + acetic acid
L- a -glycerophosphate oxidase
peroxidase
H2O2 + leuco dye
2,3-diacetylglycerol + oleic acid
• dihydroxyacetone phosphate + H2O2
dye + 2H2O
Test Type and Conditions for LIPA DT
Test Type
Rate
Version 1.0
VITROS DT60 II
Module
DTSC II
Approximate
Incubation Time
5 minutes
Pub. No. C-356
Temperature
37°C (98.6°F)
Wavelength
540 nm
Sample Drop
Volume
10 uL
LIPADT
Lipase
Reagents
Slide Diagram
Slide Ingredients
,
2
Diacetinase (Bacillus subtilis, E.C.3.1.1-) 0.54 U; glycerol kinase (£. coli or
Cellulomonas sp, E.C.2.7.1.30) 0.32 U; L-a-glycerophosphate oxidase
{Aerococcus viridans, E.C.1.1.3.21) 0.39 U; peroxidase (horseradish root,
E.C.1.11.1.7) 0.62 U; colipase (porcine pancreas) 5.9 U; adenosine triphosphate
0.16 mg; 1-oleoyl-2,3-diacetylglycerol 0.80 mg; and 2-(3,5-dimethoxy4-hydroxyphenyl)-4,5-bis(4-dimethylaminophenyl)imidazo!e (leuco dye) 33 ng.
^"T
Other ingredients
~~*~~>
3
•'
4
"~ "
Pigment, binders, surfactants, enzyme cofactors, stabilizers, buffer, dye
solubilizer, scavenger and cross-linking agent.
2. Spreading layer {TIO2)
• colipase
• 1-oleoyl-2,3-diace1ylglycerol
3. Reagent layer
•buffer, pH 8.5
• diacetinase
• glycerol kinase
• ATP
• L-a-glycerophosphate
oxidase
• peroxidase
• leuco dye
4. Support layer
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-28X: (64°-82°F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS LIPA DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for LIPA DT
Slides
Unopened
Opened
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
Room temperature
18°-28°C (64°-82°F)
Pub. No. C-356
Stability
<48 hours
<4 weeks
<15 minutes
Version 1.0
Q VITRCpS
UPADT
Lipase
I
VM
•
•
Serum
Plasma:
Heparin
IMPORTANT:
•
Do not use grossly lipemic specimens. Refer to "Limitations of the Procedure."
Serum and Plasma
.
Patient Preparation
Special Precautions
• Ensure equipment is free from soap or giyceroi contamination. Collection tubes with glycerol-lubricated stoppers should not
be used.
Specimen Storage and Stability for LIPA DT: Serum and Plasma7
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
18°-28°C(64O-82OF)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<7 days
<3 weeks
<5 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products LIPA DT Slides
•
•
•
•
.
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT;
analysis.
Sample Dilution
If lipase activities exceed the system's reportable (dynamic) range or if samples are flagged with an L-11 or L-13 error code:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's lipase activity.
Version 1.0
Pub. No. C-356
1IPADI
Lipase
Calibration
Calibration
When to Calibrate
Calibrate:
The VITROS LIPA DT test may also need to be calibrated:
Calculations
activity. Once a calibration has been performed for each slide lot, lipase activity in unknown samples can be determined from
the rate of change in reflectance measured for each unknown test slide.
a calibration.
Reportable (Dynamic) Range for LIPA DT
10-2000
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for lipase are traceable to the measurement of lipase
I
activity in a standard triolein emulsion with a pH-Stat analyzer.8
Quality Control
|
' '
•
•
•
•
•
•
4
Pub. No. C-356
Version 1.0
El VITRcffS
LIPADT
Lipase
IMPORTANT;
•
•
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other lipase methods if
they:
Liquid controls are not recommended because they often contain high concentrations of glycerol, which result in L-11 or
L-13 codes. Refer to "Limitations of the Procedure."
Do not use control materials stabilized with ethylene giycol.
• Quality Control Material Preparation and Storage
Reference Interval
This reference interval is based on results from an internal study of 496 apparently healthy individuals, ages 10-90. No
significant differences in results between male and female populations were observed. Lipase activities tend to increase
with age.10
Reference Interval for LIPA DT
Conventional and SI Units (UL)
23-300
The VITROS DT60 II Chemistry System may be programmed to report LIPA DT results in conventional and SI units.
Reporting Units for LIPA PT
U/L
Known Interferences
•
Carboxylesterases generally do not interfere with lipase results. Extremely high activity of carboxylesterase
(e.g., 51000 U/L) will show a bias of +240 U/L at a lipase activity of 35 U/L.
• Grossly lipemic samples may show a large negative bias.
The VITROS LIPA Slide method was screened for interfering substances following NCCLS Protocol EP7.11 The substances
Known Interfering Substances for LIPA DT
Interferent*
5-Aminosalicylate
Interferent
Concentration
23mg/dL
(1.5mmol/L)
Lipase Activity
200
Average Bias
-28
Other Limitations
•
•
Version 1.0
Normal endogenous concentrations of glycerol do not interfere with this method; however, samples containing high
concentrations of glycerol will be flagged with the L-11 or L-13 error code. Samples flagged with a L-11 or L-13 error code
should be diluted and reanalyzed. Refer to "Sample Dilution." Highly elevated glycerol concentrations are usually caused by
contamination from rubber stoppers, latex gloves or hyperalimentation fluids. If the L-11 or L-13 error code was caused by
glycerol contamination, the final lipase result may be normal.
Certain drugs and clinical conditions are known to alter lipase activity in vivo. For additional information, refer to one of the
published summaries.1213
Pub. No. C-356
LIPADT
Lipase
Methpd Comparison
I
The plot and table show the results of a comparison of the VITROS DT60 II Chemistry System with the VITROS 700 Chemistry
System. Testing followed NCCLS Protocol EP9.14
Method Comparison for LIPA DT: Serum
y =x
2000
1500
5
1000
D
to
O
500 •
500
1000
1500
2000
(U/L)
Method Comparison for LIPA DT: Serum
DT60 II System vs.
700 System
n
Slope
Intercept
Sy.x
49
1.00
0.999
36-1800
0.38
18.62
Precision
Precision was evaluated with quality control materials on VITROS DT60 II System following NCCLS Protocol EP5.16
Precision for LIPA DT: Serum
System
Mean Activity
Within Day SD*
VITROS DT60 II
182
1.9
2.7
1.5
5.4
8.2
1.2
674
* Within Day precision was determined using two runs/day with two replications.
** Within Lab precision was determined using a single lot of slides and calibrating weekly.
Pub. No. C-356
No. Observ.
No. Days
88
88
22
22
'
Version 1.0
I*J VITRI
LIPADT
Lipase
References
References
1.
2.
4.
5.
Mauck JC, Weaver MS, Stanton C. Development of a Kodak Ektachem Clinical Chemistry Slide for Lipase (Abstract). Clin. Chem.
30:1058-1059; 1984.
6.
3.
1991.
1991.
7.
8. Tietz, NW, Repique, EV. Proposed Standard Method for Measuring Lipase Activity in Serum by a Continuous Sampling Technique.
Clin. Chem. 19:1268-1275; 1973.
9. NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline-Second Edition..
10. Vankampen L, DiPaola J, Gambino R. Lipase Normals - Some Data. Lab Report 12 (November); 1990.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
REF
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Store At or Below
This end up
Catalog Number or
Product Code
Attention: See
Version 1.0
X
I
Store At or Above
Pub. No. C-356
LIPflDT
Lipase
Revision History
Revision History
Date of
Revision
2003-03-28
Version
1.0
Specimens Not Recommended - plasma: removed oxalate/fluoride, citrate, and
EDTA
• Specimen Storage and Stability - updated all stabilities
• Quality Control Material Selection - added statements regarding liquid controls,
enzyme activity, and ethylene glycol
• Limitations of the Procedure - removed sodium deoxycholate; updated bias due
to carboxylesterase; added L-13 error code and removed >AR
• Method Comparison - corrected the slope value
• References - added all but 10
•
•
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
^c&mcH company
Pub. No. C-356
Version 1.0
Products
Chemistry
MgDT
VITROS Chemistry Products Mg DT Slides
Magnesium
Intended Use
VITROS Mg DT Slides quantitatively measure magnesium (Mg) concentration in serum and plasma.
Magnesium is predominantly an intracellular cation and is essential in enzyme reactions. Magnesium deficiency may cause
weakness, tremors, tetany, and convulsions. Hypomagnesemia is associated with hypocalcemia, alcoholism, some types of
malnutrition, malabsorption, chronic hemodialysis, and pregnancy. Increased serum magnesium concentrations occur in
patients with renal failure, dehydration, and Addison's disease.1
The VITROS Mg DT Slide method is performed using the VITROS Mg DT Slide and the VITROS Chemistry Products
The VITROS Mg DT Slide is a multilayered, analytical element coated on a polyester support.
Magnesium (both free and protein-bound) from the sample then reacts with the formazan dye derivative in the reagent layer;
the high magnesium affinity of the dye dissociates magnesium from binding proteins. The resulting magnesium-dye complex
causes a shift in the dye absorption maximum. The amount of dye complex formed is proportional to the magnesium
concentration present in the sample and is measured by reflection density.
Reaction Sequence
Mg*2 + Ca*2-chelator complex
Mg2 + Ca+2
Mg+2 + formazan dye derivative
pH 9.75
Mg -dye complex
Test Type and Conditions for Mg DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
660 nm
Sample Drop
Volume
10 uL
solid and liquid waste, and test components in accordance with local regulations and NCCLS Guideline M29Z or other
Version 1.0
Pub. No. C-349
VITFJCpS gj
NlgDT
Reagents
Magnesium
Reagents
Slide Diagram
Slide Ingredients
1
1,2-bis(o-aminophenoxy)ethane-N,N,N',N'-tetraacetic acid (calcium chelator) 242 (
and 1,5-bis(2-hydroxy-3,5-dichlorophenyl)-3-cyanoformazan (dye) 38 \xg.
Other ingredients
~
Pigment, binders, buffer, dye solubilizer, surfactants, cross-linking agent and
stabilizer.
4
2. Spreading layer (TiO2)
3. Reagent layer
• calcium chelator
• buffer, pH 9.75
• formazan dye
4. Support layer
5
Slide Handling
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-28X: (64°-82°F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18 -28 °C
(64 °-82 °F) for >48 hours.
1.
2.
VITROS Mg OT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for Mg DT
Slides
Storage Condition
Unopened
Room temperature
Frozen
Room temperature
Opened
18°-28°C (64°-82°F)
<-18°C (<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
CAUTION:
Protective gloves manufactured with magnesium stearate (talc) powders may
cause elevated test results because of the contamination of sample handling
supplies (for example, pipette tips, transfer pipettes, sample cups and caps).
Supplies that have come in contact with powdered gloves may subsequently
contaminate the test specimen during sample metering.
NOTE:
Gloves labeled as "powder-free" may contain some contaminating powder agents on
the inside of the glove.
•
•
Serum
Plasma:3
IMPORTANT:
Heparin
Pub. No. C-349
Version 1.0
Mg OT
Testing Procedure
Magnesium
.
Plasma:5
EDTA
Fluoride oxalate
Citrate
Serum and Plasma
Patient Preparation
Special Precautions
• Hemolyzed specimens can cause falsely elevated results due to intracellular magnesium levels.8
• Centrifuge specimens and remove the serum or plasma from the cellular material as soon as possible after collection.1
•
•
Specimen Storage and Stability for Mg DT: Serum and Plasma5
Storage
Temperature
Stability
Room temperature
18°-28°C(64°-82''F)
<1 week
Refrigerated
2°-8°C (36°-46°F)
<1 week
Frozen
<-18°C(<0°F)
<1 month
Testing Procedure
Materials Provided
•
VITROS Chemistry Products Mg DT Slides
•
•
•
•
•
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If magnesium concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's magnesium concentration.
Version 1.0
Pub. No. C-349
MgDT
Magnesium
Calibration
Calibration
When to Calibrate
Calibrate:
The VITROS Mg DT test may also need to be calibrated:
Calculations
I
each slide lot, magnesium concentration in unknown samples can be determined using the software-resident endpoint
Calibration parameters are automatically assessed by the VITROS DT60/DT60 ll.Chemistry System against a set of quality
a calibration.
Reportable (Dynamic) Range for Mg DT
Conventional (mgfdL)
0.2-7.0
SI Units (mmol/L)
0.1-2.9
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for magnesium are traceable to the Certified
NIST (National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 929. The
Ortho-Clinical Diagnostics calibration laboratory uses SRM" 929 to calibrate the flame atomic absorption spectroscopy method9
to support magnesium value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
•••':•'•••
material.
•
•
•
T o verify system performance, analyze control materials:
After calibration.
•
4
-
According to local regulations or at least once each day that the test is being performed.
-
After specified service procedures are performed. Refer to the operator's manual for your VITROS DT60/DT60II
System.
Pub. No. C-349
Version 1.0
NlgDT
Magnesium
•
•
IMPORTANT:
•
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other magnesium
methods if they:
Reference Interval
This reference interval is the central 95% of results from an internal study of 288 apparently healthy individuals from a working
Reference Interval for Mg DT
SI Units (mmol/L)
0.7-1.0
1.6-2.3
The VITROS DT60/DT60 II Chemistry System may be programmed to report magnesium results in conventional and SI units.
Reporting Units and Unit Conversion for Mg DT
Conventional Units
SI Units
mg/dL
Known Interferences
The VITROS Mg DT Slide method was screened for interfering substances following NCCLS Protocol EP7." The substances
Known Interfering Substances for Mg DT
Interferent*
Calcium
Interferent
Concentration
20 mg/dL
(5.0 mmol/L)
Magnesium Concentration
Conv. (mg/dL)
SI (mmol/L)
2.3
0.9
Average Bias
Conv. (mg/dL)
SI (mmol/L)
+0.3
+0.12
Other Limitations
Certain drugs and clinical conditions are known to alter magnesium concentrations in vivo. For additional information, refer to
one of the published summaries.1213
Version 1.0
Pub. No. C-349
VITFJLpS Q
NlgDT
Magnesium
Method Comparison
I
Method Comparison for Mg DT: Serum
SI Units
Conventional Units
y-x
I
w
O
10
o
t
(mmol/L)
(mg/dL)
Method Comparison for Mg DT: Serum
n
DT60 II Sys.tem vs.
950 System
Range of
Correlation
Slope Coefficient
0.98
63
0.3-6.9
0.998
0.11
0.14
SI Units (mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
0.14-2.85
0.05
0.06
Precision
Precision for Mg DT: Serum
SI Units (mmol/L)
Within
Within
Day SD* Lab SD**
0.02
0.02
System
VITROS DT60 II
Mean
Cone.
2.3
5.0
Within
Day SD*
0.05
Within
Lab SD**
0.06
Mean
Cone.
1.0
0.08
0.12
2.0
0.03
0.05
Within
Lab
CV%**
No.
Observ.
No.
Days
2.5
88
22
2.4
88
22
Pub.
No. C-349
Version 1.0
MgDT
Magnesium
References
References
1.
2.
3.
4.
5.
6.
7.
Evaluation of "Plasma Separator Tubes (PST)" Clin. Chem. 35:151-153; 1989.
1991.
1991.
8.
9.
10.
11.
12.
13.
14.
15.
Kaplan L, Pesce A. Clinical Chemistry: Theory, Analysis, and Correlation. CV Mosby; 1069; 1984.
Friedman RB. Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D C : AACC Press; 1990.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Version 1.0
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Pub.
No. C-349
NlgDT
Revision History
Magnesium
Revision History
Date of
Revision
2003-10-01
*
Version
1.0
> New format
> Specimens Recommended - plasma: updated to heparin
> Limitations of the Procedure-removed inorganic phosphorous
> Method Comparison -updated all comparisons and plots
Precision: updated values
References - added all except 6, 8
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
H company
Pub.
No. C-349
Version 1.0
Chemistry
Na DT
VITROS Chemistry Products Na+ DT Slides
Sodium
Intended Use
VITROS Na+ DT Slides quantitatively measure sodium (Na+) concentration in serum and plasma.
Sodium is the major cation of extracellular fluids. The kidneys regulate sodium content of the body. Low sodium levels may be
caused by excessive urine loss, diarrhea, Addison's disease, and renal tubular disease. High sodium levels may occur in
severe dehydration, some types of brain injury, diabetic coma, and excessive intake of sodium salts.1
The VITROS Na+ DT Slide method is performed using the VITROS Na+ DT Slide and the VITROS Chemistry Products
The VITROS Na* DT Slide is a multilayered, analytical element coated on a polyester support that uses direct potentiometry2
for measurement of sodium ions. The slide consists of two ion-selective electrodes, each containing methyl monensin (an
ionophore for sodium), a reference layer, and a silver layer and a silver chloride layer coated on a polyester support.
fluids toward the center of the paper bridge. A stable liquid junction is formed that connects the reference electrode to the
sample electrode.
Each electrode produces an electrochemical potential in response to the activity of sodium. The potential difference between
the two electrodes is proportional to the sodium concentration in the sample.
Test Type and Conditions for Na* DT
Test Type
Potentiometric
VITROS DT60/DT60 II
Module
DTE/DTE II
90 or 180 seconds*
Temperature
25°C (77°F)
Drop Volume
Sample:
Reference
10 uL
Fluid: 10 uL
Assay time is determined by the Calibration Data Module (CDM).
Version 1.0
Pub. No. C-307
NaDT
Sodium
Reagents
Reagents
Slide Diagram
Slide Ingredients
___ 1
2
*
_- 3
Silver 0.4 mg; silver chloride 0.2 mg; sodium chloride 0.3 mg and
methyl monensin 50 ng.
_
-— *
Other ingredients
Binders, buffer, plasticizers, stabilizer, surfactants and nickel.
"'Y ~.
7
2. Paper Bridge
3. Ion-selective
membrane
• Methyl monensin
4. Reference layer
• NaCI
• Buffer, at pM 5.6
5. Silver, silver chloride
layer
6. Support layer
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18°-28 °C (64 °-82 f), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
VITROS Na* DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for Na* DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C (<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
•
•
I
Serum
Plasma:4
Heparin (Sodium heparin will increase the measured sodium value by approximately 0.5 mmol/L.)
IMPORTANT:
Serum and Plasma
Collect specimens using standard laboratory procedures.6'7
Patient Preparation
Pub. No. C-307
Version 1.0
NaDT
Testing Procedure
Sodium
Special Precautions
• Centrifuge specimens and remove the serum from the cellular material within 2 days of collection.9
Specimen Storage and Stability for Na* DT: Serum and Plasma9
Storage
Room temperature
Refrigerated
Frozen
Temperature
18O-28°C(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<4 days
<1 week
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products Na* DT Slides
•
•
•
•
.
VITROS DTE Pipette
•
IMPORTANT:
analysis.
Sample Dilution
Sodium concentrations outside the reportable (dynamic) range are not expected. Diluted samples should not be analyzed with
VITROS Na* DT Slides because dilution changes both the concentration of solids in plasma water and the ionic strength of the
sample.
Calibration
MOTE:
Calibrate sodium in duplicate by running each bottle twice.
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-307
3
Na DT
Sodium
Quality Control
The VITROS Na* DT test may also need to be calibrated:
Calculations
A linear relationship exists between the measured potential difference observed on the slide and the logarithm of sodium
concentration, i.e. the Nernst equation for ion-selective electrodes. Once the calibration has been established for each slide lot,
unknown sodium concentrations for a given sample can be determined using the software-resident math model and the
measured potential difference.
a calibration.
Reportable (Dynamic) Range for Na* PT
95-215
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for sodium are traceable to the Certified NIST (National
Institute of Standards and Technology) Reference Material, SRM" (Standard Reference Material) 919a. The Ortho-Clinical
Diagnostics calibration laboratory uses SRM" 919a to calibrate the flame atomic emission spectroscopy method10 to support
sodium value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
•
•
•
•
•
•
material.
System.
and Definitions; Approved Guideline-Second Edition'1'' or other published guidelines.
I
IMPORTANT;
•
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other sodium methods
if they:
Pub.
No. C-307
Version 1.0
NaDT
Sodium
•
I
R e f e r e n c e Interval
The serum reference interval is the central 95% of results from an internal study of 60 apparently healthy adults from a working
population. No significant differences between results from the male and female populations were observed.
Reference Interval for Na+ DT
137-145
Reporting Units
The VITROS DT60/DT60 II Chemistry System may be programmed to report sodium results in conventional and SI units.
Reporting Units for Na* DT
mmol/L
Known Interferences
Specimens contaminated with cationic surfactants show a positive interference (e.g., benzalkonium chloride at 10 mg/L caused
a 50 mmol/L apparent increase in sodium).
NOTE:
Heparinized catheters may contain benzalkonium chloride. Specimens drawn through
these catheters should not be used.
Other Limitations
Certain drugs and clinical conditions are known to alter sodium concentration in vivo. For additional information, refer to one of
the published summaries.12'13
Version 1.0
Pub. No. C-307
NaDT
Sodium
Method Comparison
using the Flame Photometry comparative method.10 Testing followed NCCLS Protocol EP9."
The table also shows the results of a comparison of the VITROS Na* DT Slide at an assay time of approximately 90 seconds
with the VITROS Na+ DT Slide at an assay time of approximately 180 seconds.
Method Comparison for Na* DT: Serum
250 •
200
150
100
50
50
200
150
100
250
Comparative Method: Flame Photometry
(mmol/L)
Method Comparison for Na *DT: Serum
Conventional and SIUnits (mmol/L)
n
Slope
Range of Sample Cone.
Intercept
Sy.x
DT60II System vs.
comparative method
58
0.99
0.960
117-166
-1.43
2.97
90 seconds vs.
180 seconds
59
0.98
0.999
101-185
+2.38
0.85
Precision
Precision was evaluated with quality control materials on the VITROS DT60 II System following NCCLS Protocol EP5.'6
Precision for Na* DT: Serum
System
VITROS DT60 II
Mean Cone .
Within Day SD*
No. Observ.
No. Days
115
0.7
1.3
1.2
87
133
0.8
1.4
1.0
88
22
22
Pub. No. C-307
Version 1.0
Na DT
Sodium
References
References
1.
2.
3.
Siggard-Anderson O. Electrochemistry, in Tietz NW (ed). Textbook of Clinical Chemistry. Philadelphia: WB Saunders; 110-125; 1986.
4.
5.
6.
1991.
7.
8.
9.
10.
11.
12.
13.
14.
15.
1991.
Slockbower JM, BlumenfeldTA (ed.). Collection and Handling of Laboratory Specimens. Philadelphia: Lippincott Co; 201; 1983.
Velapoldi R.A., et al. A reference method for the determination of sodium in serum. National Institute of Standards and Technology
Special Publication 260-60, Gaithersburg. MD, 1978.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Date (YYYY-MM-DD)
Lot Number
REJF
Version 1.0
BEP |
\/
Pub. No. C-307
Ha DT
Sodium
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
> New format
• Reference Interval - corrected the sample size
> Limitations of the Procedure - removed the statement regarding ethanol
> Method Comparison - updated all data and the plot
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
jjjotmHm company
Pub. No. C-307
Version 1.0
VITR
Chemistry
NBIL DT
VITROS Chemistry Products NBIL DT Slides
Neonatal Bilirubin
Intended Use
VITROS NBIL DT Slides quantitatively measure total bilirubin concentration in serum and plasma in neonates during the first
weeks of life.
Neonatal bilirubin (NBIL) is increased in erythroblastosis fetalis (hemolytic disease of the newborn), which causes jaundice in
the first two days of life. Other causes of neonatal jaundice include physiologic jaundice, hematoma/hemorrhage,
hypothyroidism, and obstructive jaundice.
The VITROS NBIL DT Slide method is performed using the VITROS NBIL DT Slide and the VITROS Chemistry Products
The VITROS NBIL DT Slide is a multilayered, analytical element coated on a polyester support. The analysis is based on a
modification of the classic diazo reaction.1
layer provides a reflective background for measuring the diazo products of bilirubin and contains all reagents necessary to
determine total bilirubin in neonates.
The method uses dyphylline to dissociate unconjugated bilirubin from albumin. Unconjugated bilirubin and conjugated bilirubin
subsequently react with the diazonium salt 4-(A/-carboxymethylsulfonyl) benzenediazonium hexafluorophosphate to produce
azobilirubin chromophores that have similar molar absorptivities.
The change in reflection density is proportional to the bilirubin concentration in the sample.
Reaction Sequence
dyphylline
neonatal bilirubin
[4-(N-carboxymethylsulfonyl)-benzenediazonium hexafluorophosphate]
azobilirubin chromophores
Test Type and Conditions for NBIL DT
Test Type
Colori metric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-364
NBILDT
Neonatal Bilirubin
Reagents
Reagents
Slide Diagram
Slide Ingredients
2
2
Dyphylline 0.5 mg and 4-(N-carboxymethylaminosulfonyl) benzene diazonium
hexafluorophosphate 57 (.ig.
Other ingredients
_ 3
~~~~ ~ 4
Pigment, binders, buffer, mordant, surfactants and stabilizer.
_____
_
2. Spreading layer (BaSCXtl
• dyphylline
• diazonium salt
3. Reagent layer
• buffer, pH 3.0
4. Support layer *
S
Slide Handling
CMJTiGM:
Slide Preparation
IMPORTANT:
opened.
(64°-82°F) for >48 hours.
VITROS NBIL DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for NBIL DT
Storage Condition
Slides
Room temperature
Frozen
Room temperature
Unopened
Opened
18°-28°C (64°-82°F)
<-18°C (<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
WARNiNG:
I
•
•
Serum
Plasma:3
Heparin
•
Samples from patients other than neonates (newborns) are not recommended. These samples should be analyzed on the
VITROS TBIL DT Slide.
Serum and Plasma
Patient Preparation
Pub. No. C-364
Version 1.0
NRIL DT
Testing Procedure
Neonatal Bilirubin
Special Precautions
• Protect specimens from light.
• Direct exposure to sunlight is reported to cause as much as a 50% loss of serum bilirubin in one hour, especially when the
specimen is kept in capillary tubes.1
• Exposure to normal laboratory light can result in a significant loss of serum bilirubin after two to three hours.
•
•
•
Specimen Storage and Stability for NBIL DT: Serum7
Temperature
Storage
Room temperature
Refrigerated
Frozen
18°-28°C(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<4 hours
<7 days
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products NBIL DT Slides
•
•
•
•
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If bilirubin concentrations exceed the system's reportable (dynamic) range:
1. Dilute the sample with VITROS 7% BSA.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's bilirubin concentration.
Calibration
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-364
VI"TFj[Cp"S | * |
NBILDT
Neonatal Bilirubin
Quality Control
The VITROS NBIL DT test may also need to be calibrated:
Calculations
each slide lot, neonatal bilirubin concentration in unknown samples can be determined using the software-resident endpoint
a calibration.
Reportable (Dynamic) Range for NBIL DT
0.1-20.0
SI Units (umol/L)
2-342
I
i
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for neonatal bilirubin are traceable to internal Master
Lots of VITROS Chemistry Products BuBc Slides and VITROS Calibrator Kit 4. Performance of the Master Lot of VITROS
BuBc slides was initially established by comparison to the High Performance Liquid Chromatography (HPLC) method described
by Lauff et al.8 The Ortho-Clinical Diagnostics (OCD) calibration laboratory uses the Master Lot of VITROS BuBc Slides and
Master Lot of VITROS Calibrator Kit 4 for neonatal bilirubin value assignment for new lots of the VITROS DT Calibrator Kit.
Quality Control
|
'
•
•
•
•
•
•
System.
|
IMPORTANT:
|
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other neonatal bilirubin
methods if they:
•
Pub. No. C-364
Version 1.0
NBIIDT
Neonatal Bilirubin
Reference Interval
This reference interval is the central 95% of results from a study of 40 apparently healthy neonates (average age 1.2 days) with
normal liver enzymes.
Reference Interval for NBIL DT
SI Units (umol/L)
1.0-10.5
17-180
Neonates
The VITROS DT60/DT60 II Chemistry System may be programmed to report neonatal bilirubin results in conventional and
SI units.
Reporting Units and Unit Conversion for NBIL DT
Conventional Units
SI Units
mg/dL
Known Interferences
The VITROS NBIL Slide method was screened for interfering substances following NCCLS Protocol EP7.10 The substances
Known Interfering Substances for NBIL DT
Interferent*
Levodopa
4-Aminosalicylic acid
Phenazopyridine
Biliverdin
Hemoglobin
Bilirubin Cone.
SI (Mmol/L)
Conv. (mg/dL)
0.4
(1.52mmol/L)**
7
(1.52 mmol/L)**
17.8
304
(0.52 mmol/L)
0.4
7
(0.52 mmol/L)
17.6
301
(0.3 mmol/L)
0.4
7
(0.3 mmol/L)
17.4
298
0.3
(69 umol/L)
5
16.4
(69 umol/L)
280
0.5
9
d g/L)
0.5
9
(2 g/L)
0.5
9
(4 g/L)
10.5
180
(1 g/L)
10.5
(2 g/L)
180
10.5
(4 g/L)
180
15.0
257
(1 g/L)
15.0
257
(2 g/L)
15.0
(4 g/L)
257
Interferent
Concentration
300 ug/mL**
300 |.ig/mL**
8 mg/dL
8 mg/dL
8 mg/dL
8 mg/dL
4 mg/dL
4 mg/dL
100 mg/dL
200 mg/dL
400 mg/dL
100 mg/dL
200 mg/dL
400 mg/dL
100 mg/dL
200 mg/dL
400 mg/dL
Bias
SI
Conv. (mg/dL)
+1.4
-9.4
+0.4
+2.5
+3.8
+3.5
+0.5
+0.7
+0.1
+0.4
+ 1.3
-1.0
-1.2
-1.0
-1.2
-1.7
-1.9
(Mmol/L)
+24
-161
+7
+43
+65
+60
+9
+12
+2
+7
+22
-17
-21
-17
-21
-29
-32
This concentration may be present in the treatment of Parkinson's disease.
Version 1.0
Pub. No. C-364
NBIL DT
Neonatal Bilirubin
Other Limitations
•
It is important to maintain consistency in bilirubin methodology. If VITROS NBIL DT Slides are initially used to monitor a
patient, continue to monitor that patient with VITROS NBIL DT Slides. Do not switch to VITROS TBIL DT Slides regardless
of the patient's age.
Results from the VITROS NBIL DT Slide may not be accurate at elevation greater than 6000 feet (approx. 1800 meters)
above sea level.
Cefotiam (Pansporin) has been reported to show very large positive biases on VITROS NBIL DT Slide results.11 This drug
is normally cleared through the kidney. Biases will be largest in specimens from patients with renal insufficiency and may
be as large as 5 mg/dL (86 |.imol/L).
Drugs and other compounds that are diazo-reactive or that absorb light in the vicinity of 555 nm may interfere.
Certain drugs and clinical conditions are known to alter total bilirubin concentration in vivo. For additional information, refer
to one of the published summaries.1213
•
•
•
•
Method Comparison
I
I
using the VITROS 950 System and VITROS BuBc Slides to calculate NBIL. Testing followed NCCLS Protocol EP9.14
Method Comparison for NBIL DT: Serum
Conventional Units
SI Units
400
25
t
20
300
E
r
! *>
f£
10
200
Q
W
O
a:
>
Q
10
15
100
20
0
100
(mg/dL)
200
300
400
(Mmol/L)
Method Comparison for NBIL DT: Serum
SI Units (umol/L)
n
DT60 II System vs.
950 System
104
Correlation
Slope Coefficient
0.99
0.998
Range of
Sample Cone.
Intercept
0.1-18.2
0.10
Sy.x
Range of
Sample Cone.
Intercept
Sy.x
0.32
2-312
1.63
5.48
Precision
Precision for NBIL DT: Serum
System
VITROS DT60 II
Within
Within
Mean
Cone.
Day SD* Lab SD**
1.3
14.5
SI Units (Mmol/L)
Mean
Cone.
Within
Day SD*
0.10
0.10
23
1.6
0.22
0.29
248
3.8
Within
Lab SD**
1.8
5.0
Within
Lab
CV%**
No.
Observ.
No.
Days
7.8
84
21
2.0
84
21
Pub.
No. C-364
Version 1.0
NBILDT
References
Neonatal Bilirubin
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
Routh Jl: Liver Function. In Tietz NW(ed). Fundamentals of Clinical Chemistry, ed 2. Philadelphia; WB Saunders; 1037; 1976.
Tissue: Approved Guideline. NCCLS Document M29 (OSBN 1-56238). NCCLS, Wayne, PA 19087; 1997.
1991.
1991.
Lauff JJ, Kasper ME, Wu T.W, Ambrose RT. Isolation and preliminary characterization of a fraction of bilirubin in serum that is firmly
bound to protein. Clin. Chem. 28:629-637, 1982.
NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions: Approved Guideline-Second Edition.
Pickert A, Riedlinger I, Stumvill M. Interference of Cefotiam with Total Bilirubin Measured with the Ektachem Analyzer. Clin. Chem.
38:599-600; 1992.
NCCLS. Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline. NCCLS Document EP9. Wayne, PA:
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date (YYYY-MM-DD)
Lot Number
Q|L|
On!
"^rzi
MfcX [
mf I
\ y /
V
Number
Catalog Number or
Product Code
Attention: See
Version 1.0
BC
X
Manufacturer
Store Between
Use
Tests
Care.
Keep Dry
Store At or Below
This end up
Store At or Above
Pub. No. C-364
NBILDT
Neonatal Bilirubin
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
> New format
> Known Interfering Substances - updated values; added phenazopyridine and
hemoglobin; changed 5-aminosalicylic acid to 4-aminosalicylic acid
> Method Comparison - updated all comparisons and the plots
> References - added all except 6, 12,13
Signature
Obsolete Date
C€
I EC j REP I
Mandeville House
62 The Broadway
Amersham
England
company
Pub. No. C-364
Version 1.0
VITR
Chemhtry
NHsDT
Ammonia
Intended Use
VITROS NH3 DT Slides quantitatively measure ammonia (NH3) concentration in plasma.
Ammonia is a waste product of protein catabolism; it is potentially toxic to the central nervous system. Increased plasma
ammonia may be indicative of hepatic encephalopathy, hepatic coma in terminal stages of liver cirrhosis, hepatic failure, acute
and subacute liver necrosis, and Reye's syndrome. Hyperammonemia may also be found with increasing dietary protein
intake.1
In addition to its use for endogenous ammonia determination, the VITROS NH3 DT Slides are also used in conjunction with
VITROS CREA DT Slides for creatinine as described in the VITROS Chemistry Products CREA DT Instructions for Use (blankcorrected method).
The VITROS NH3 DT Slide method is performed using the VITROS NH3 DT Slide and the VITROS Chemistry Products
The VITROS NH3 DT Slide is a multilayered, analytical element coated on a polyester support.
Water and nonproteinaceous components travel to the underlying buffered reagent layer, and the ammonium ions are
converted to gaseous ammonia. The semipermeable membrane allows only ammonia to pass through and prevents buffer or
hydroxyl ions from reaching the indicator layer. After a fixed incubation period, the reflection density of the dye is measured
using the white background of the spreading layer as a diffuse reflector.
Reaction Sequence
blue dye
NH3 + bromphenol blue
(ammonia indicator)
Test Type and Conditions for NH3 DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
605 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-333
NHaDT
Reagents
Ammonia
Reagents
Slide Diagram
Slide Ingredients
2
Bromphenol blue 27 pg.
Other ingredients
-4
Pigment, binders, surfactants, buffer and stabilizer.
"-
5
3. Reagent layer
• buffer, pH 9.3
4. Semlpermeable
membrane
5. Indicator layer
• bromphenol blue
6. Support layer
Slide Handling
N:
Slide Preparation
opened.
Do not use unopened slides that have been at room temperature, 18 - 2 8 °C
(64 °-82 °F) for >48 hours.
1.
2.
VITROS NH? DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for NH3 DT
Storage Condition
Slides
Unopened
Room temperature
Refrigerated
Frozen
Room temperature
Opened
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<4 weeks
<15 minutes
WARNING:
Specimens Recommended for Measurement of Ammonia
I
I
I
I
•
Plasma:3
EDTA
Meparin (except ammonia heparin)
NOTE:
Serum should not be used for ammonia measurements because ammonia is
produced during the clotting process.3
IMPORTANT:
Specimens Recommended for Measurement of Creatinine Where Ammonia Serves as Blank
I
|
I
•
Plasma:3
•
Serum
IMPORTANT:
EDTA
Heparin (except ammonia heparin)
Pub. No. C-333
Version 1.0
NHsDT
Testing Procedure
Ammonia
• Do not use hemolyzed specimens.3
Plasma or Serum
Piasma
• Collect specimens using standard laboratory procedures.5 6
• Keep on ice until analysis.5 6
Serum
• Collect specimens using standard laboratory procedures.5 6
• Do not put specimens on ice.
Patient Preparation
•
Special Precautions
NOTE:
Avoid using ammonia-containing cleaning solutions or hand creams in the area
around the analyzer.
•
Centrifuge specimens and remove the plasma from the cellular material within 15 minutes of collection.3
Specimen
\fi
•
•
Handling and Storage
Handle specimens as biohazardous
material.
Mix samples by gentle inversion and bring to room temperature, 18°-28°C (64°-82°F); analyze immediately.
Specimen Storage and Stability for NH3 DT: Plasma3
Storage
Temperature
Room temperature
Refrigerated
Frozen
18°-28°C(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
not recommended
<3 hours
<24 hours
Testing Procedure
Materials Provided
.
•
•
•
•
•
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
immediately.
Sample Dilution
If ammonia concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's ammonia concentration.
Version 1.0
Pub. No. C-333
NH.DT
Ammonia
Calibration
Calibration
VITROS Chemistry Products DT Calibrator Kit, bottles 1, 2, 3, and 4
NOTE:
To avoid ammonia formation, calibrator fluids should be prepared only when ready to
calibrate and should be run within 1 hour after preparation.
NOTE;
Because ammonia is produced in the VITROS BUN/UREA DT Slide reaction, the
analyzer will display a warning message "ANALYER READY—NO CREA/NH3" during
calibration of VITROS BUN/UREA DT Slides. Therefore, it is recommended that
creatinine and ammonia be the first tests calibrated after the preparation of calibrator
fluids.
When to Calibrate
NOTE:
The VITROS CREA DT test is dependent on correct calibration of the VITROS NH3 DT
Slides used as blanks. Therefore, the NH3 DT Slides must be calibrated whenever
CREA DT Slides are calibrated.
Calibrate:
The VITROS NH3 DT test may also need to be calibrated:
Calculations
I
each slide lot, ammonia concentration in unknown samples can be determined using the software-resident endpoint
I
a calibration.
Reportable
(Dynamic) and
Range
for NH
Conventional
SI Units
(umol/L)
3 DT
1-500
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for ammonia are traceable to gravimetrically prepared
standards made from reagent grade ammonium sulfate. The Ortho-Clinical Diagnostics calibration laboratory uses the
gravimetrically prepared standard to calibrate an enzymatic procedure using glutamate dehydrogenase to measure ammonia7
to support value assignment for the VITROS DT Calibrator Kit.
Pub. No. C-333
Version 1.0
NHsDT
Quality Control
Ammonia
Quality Control
|
: llfJG
•
•
•
•
•
•
System.
IMPORTANT;
I
•
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other ammonia
methods if they:
Reference Interval
population (34 females and 26 males). No significant differences between results from the male and female populations were
observed.
Reference Interval for NH3 OT
Conventional and SI Units (umol/L)
9-30
The VITROS DT60/DT60 II Chemistry System may be programmed to report ammonia results in conventional and SI units.
Reporting Units for NH 3 DT
umol/L
Version 1.0
Pub. No. C-333
NHaDT
Ammonia
Known Interferences
•
•
Glucose at 600 mg/dL (33.3 mmol/L) may cause a decrease of 40 umol/L j n ammonia concentration.
If an NH3 slide follows a BUN/UREA DT Slide immediately, high BUN values may increase ammonia values.
- A BUN value up to 40 mg/dL (14.3 mmol/L) may increase ammonia values by 34 umol/L.
- BUN values over 40 mg/dL (14.3 mmol/L) will cause the analyzer to print an R18 code next to the ammonia result.
Discard the result and repeat the sample without the BUN/UREA DT Slide in the incubator.
I
IMPORTANT:
NH3 DT testing should not be done when any BUN/UREA DT Slides are in the
incubator.
Other Limitations
Certain drugs and clinical conditions are known to alter ammonia concentration in vivo. For additional information, refer to one
of the published summaries.9'1C
Method Comparison
I
Method Comparison for NH3 DT
500
400
£
300
200
o
oc
I00 •
100
200
300
4li(i
500
(Mmol/L)
Method Comparison for NH3 DT
Conventional and SI Units (Mmol/L)
DT60 II System vs.
950 System
n
Slope
Range of Sample Cone.
Intercept
Sy.x
59
1.02
0.997
5-460
3.71
10.73
Pub. No. C-333
Version 1.0
gj VITRCpS
NHaDT
Ammonia
References
Precision
Precision for NH3DT
Conventional and SI Units (pmol/L)
System
Mean Cone.
VITROS DT60 II
Within Day SD*
Within Lab SD**
Within Lab CV%**
No. Observ.
No. Days
69
6.3
6.8
10.0
88
22
235
14.6
16.2
6.9
88
22
References
1.
2.
4.
5
1991.
1991.
7. Bruce WA, Leiendecker, CM, Freier EF. Two-Point Determination of Plasma Ammonia with the Centrifugal Analyzer.
Clin. Chem. 24:782; 1978.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Manufacturer
Store Between
[ EC [ na> [
Use
\ v/
V
Tests
Do Not Reuse
Date (YYYY-MM-DD)
Lot Number
Version 1.0
Number
Catalog Number or
Product Code
Store At or Below
Attention: See
Store At or Above
Pub. No. C-333
I
Care.
Keep Dry
It
This end up
NHsDT
Ammonia
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
> New format
> Specimens Recommended - updated wording for heparin; added EDTA
> Reference Interval - updated upper limit
> Limitations of the Procedure - updated interferent statements
> Method Comparison - updated all comparisons and the plot
Signature
Obsolete Date
C€
EC i REP i
Mandeville House
62 The Broadway
Amersham
England
a £ofMttm«ô&Mfm company
Pub. No. C-333
Version 1.0
Products
VITR
Chemistry
PHOS DT
VITROS Chemistry Products PHOS DT Slides
Phosphorus
Intended Use
VITROS PHOS DT Slides quantitatively measure phosphorus (PHOS) concentration in serum and plasma.
Phosphorus, as phosphate, is distributed throughout the body. Causes of high serum phosphorus include dehydration,
hypoparathyroidism, hypervitaminosis D, metastases to bone, sarcoidosis, pulmonary embolism, renal failure, and diabetes
mellitus with ketosis. Low serum phosphorus is found in primary hyperparathyroidism and other causes of serum calcium
elevation, sepsis, vitamin D deficiency, renal tubular disorders, chronic hemodialysis, vomiting, and occasionally with
decreased dietary phosphate intake.1
The VITROS PHOS DT Slide method is performed using the VITROS PHOS DT Slide and the VITROS Chemistry Products
The VITROS PHOS DT Slide is a muitiiayered, analytical element coated on a polyester support. The analysis is based on the
reaction of inorganic phosphate with ammonium molybdate to form an ammonium phosphomolybdate complex at acidic pH, as
described by Fiske and Subbarow.2 p-Methylaminophenol sulfate, an organic reductant reported by Gomori,3 reduces the
complex to form a stable heteropoiymolybdenum blue chromophore.
A drop of patient sample is deposited on the slide and is evenly distributed by the. spreading layer to the underlying layers.
Phosphorus in the specimen forms a complex with ammonium moiybdate. This complex is reduced by p-methylaminophenol
sulfate to give a blue complex.
The concentration of phosphorus in the sample is determined by measuring the heteropoiymolybdenum blue complex by
reflectance spectrophotometry.
Reaction Sequence
pH4.2
inorganic phosphate + ammonium molybdate
—>• ammonium phosphomolybdate complex
p-methylaminophenol sulfate
ammonium phosphomolybdate complex
->•
heteropolymolybdate blue
Test Type and Conditions for PHOS DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
660 nm
Sample Drop
Volume
10 ML
Version 1.0
Pub. No. C-350
PHOS DT
Reagents
Phosphorus
Reagents
Slide Diagram
Slide Ingredients
I
I
2
p-methylaminophenol sulfate 350 ug; and ammonium molybdate 340 ug.
Other ingredients
-
Pigment, binders, surfactants, buffer and stabilizers.
—-__
^__
.. - -
-
3. Reagent layer
• p-methylaminophenol
sulfale
• ammonium molybdate
• buffer, pH 4.2
4. Support layer
s
Slide Handling
CAUTiOH:
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18 °-28 °C (64 "-82 °F), before the wrapper is
opened.
Do not use unopened slides that have been at room temperature, 18 °-28 "C
(64°-82°F) for >48 hours.
1.
2.
VITROS PHOS DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for PHOS DT
Slides
Unopened
Storage Condition
Room temperature
18°-28°C(64°-82° F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
18°-28°C(64°-82° F)
Room temperature
Opened
Stability
<48 hours
<15 minutes
WARNING:
•
•
Serum
Plasma:5
IMPORTANT:
Heparin
Certain collection devices have been reported to affect other analytes and tests.e
.
•
Plasma:7
EDTA
Fluoride oxalate
Citrate
Do not use hemolyzed specimens. Hemolysis produces elevated phosphorus values due to the inorganic phosphates and
phosphatases present in red blood cells.7
Pub.
No. C-350
Version 1.0
gl VITRI
PHOS DT
Testing Procedure
Phosphorus
Serum and Plasma
•
Patient Preparation
Special Precautions
•
•
Specimen Storage and Stability for PHOS PT: Serum and Plasma10
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28 o C(64°-82 0 F)
2°-8°C (36°-46°F)
<-18°C (<0°F)
Stability
<3 days
<7 days
<2 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products PHOS DT Slides
•
•
•
•
.
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If phosphorus concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's phosphorus concentration.
Calibration
Required Calibrators .
Version 1.0
Pub. No. C-350
PHOSDT
Phosphorus
Quality Control
When to Calibrate
Calibrate:
The VITROS PHOS DT test may also need to be calibrated:
Calculations
each slide lot, phophorous concentration in unknown samples can be determined using the software-resident endpoint
a calibration.
Reportable (Dynamic) Range for PHOS DT
SI Units (mmol/L)
0.16-4.20
0.5-13.0
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for phosphorus are traceable to the Certified
NIST (National Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 200. The
Ortho-Clinical Diagnostics (OCD) calibration laboratory uses SRM®200 to calibrate the phosphomolybdate/phenylenediamine
method11 to support value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
•"
•
•
•
•
•
•
System.
Pub. No. C-350
Version 1.0
PHOS DT
Phosphorus
IMPORTANT:
•
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other phosphorus
methods if they:
- Contain high concentrations of preservatives, stabilfzers, or other nonphysiological additives.
Reference Interval
The reference interval is the central 95% of results from an internal study of 297 apparently healthy adults from a working
population.
Reference Interval for PHOS DT
2.5-4.5
SI Units (mmol/L)
0.81-1.45
The VITROS DT60/DT60 II Chemistry System may be programmed to report phosphorus results in conventional and SI units.
Reporting Units and Unit Conversion for PHOS DT
Conventional Units
SI Units
mg/dL
Known Interferences
Mannitol may increase phosphorus results. At 5 mg/dL (1.6 mmol/L) phosphorus, 640 mg/dL (35 mmol/L) D-mannitol caused a
10% increase.
Other Limitations
Certain drugs and clinical conditions are known to alter phosphorus concentration in vivo. For additional information, refer to
one of the published summaries.13 u
Version 1.0
Pub. No. C-350
PHOSDT
Phosphorus
Method Comparison
I
using the Fiske and Subbarow comparative method2, modified by Dryer, Tamnes, and Routh.11 Testing followed NCCLS
Protocol EP9.15
Method Comparison for PHOS DT: Serum
Conventional Units
SI Units
14-
la|
ics'
6-
D
4 •
2
2 .
Q
CO
O
0
10
0
12
14
Comparative Method: Modified Fiske and Subbarow
(mg/dL)
Comparative Method: Modified Fiske and Subbarow
(mmol/L)
Method Comparison for PHOS DT: Serum
n
DT60 II System vs.
comparative method
69
Correlation
Slope Coefficient
0.96
0.982
Range of
Sample Cone.
Intercept
1.3-12.6
0.22
SI Units (mmol/L)
Sy.x
Range of
Sample Cone.
Intercept
Sy.x
0.63
0.43-4.08
0.07
0.20
Precision
Precision was evaluated with quality control materials on VITROS the DT60/DT60 II System following NCCLS Protocol EP5.16
Precision for PHOS DT: Serum
System
VITROS DT60 II
Mean
Within
Within
Cone.
Day SD* Lab SD**
3.2
0.04
0.08
7.0
0.07
0.14
SI Units (mmol/L)
Mean
Within
Within
Cone.
Day SD* Lab SD**
1.03
0.01
0.03
2.27
0.02
0.05
Within
Lab
CV%**
No.
Observ.
2.6
84
21
2.0
84
21
No.
Days
Pub. No. C-350
Version 1.0
PHOSDT
Phosphorus
References
References
1.
2.
3.
Fiske CH, Subbarow Y. The Colorimetric Determination of Phosphorus. J. Biol. Chem. 66:375; 1925.
Gomori G. A Modification of the Colorimetric Phosphorus Determination for Use with a Photoelectric Colorimeter. J. Lab. Clin. Med.
4.
6.
7.
8.
Tietz NW (ed). Textbook of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 1407; 1999.
9.
27:955; 1942.
5.
1991.
1991.
10.
11. Dryer RL, Tamnes AR, Routh JL. The Determination of Phophorous and Phosphatase with N-Phenyl-p-phenylenediamine. J. Biol.
Chem. 222:177; 1957. AACC Proposed Selected Method.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Version 1.0
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Pub. No. C-350
PHOSDT
Revision History
Phosphorus
Revision History
Date of
•Revision
2003-04-30
Version
1.0
• New format
» Specimens Not Recommended - added "Do not use hemolyzed specimens."
• Specimen Storage and Stability - updated data
» Materials Required But Not Provided - updated materials
> Method Comparison - updated data and plots
> Precision - updated data
> References - added all except 2, 3, 8
Obsolete Date
Signature
C€
EC I REP
Mandeville House
62 The Broadway
Amersham
England
Pub. No. C-350
Version 1.0
Products
VITRCD5
C hem i s t r y I
TBIL DT
VITROS Chemistry Products TBIL DT Slides
Total Biiirubin
Intended Use
VITROS TBIL DT Slides quantitatively measure total biiirubin (TBIL) concentration in serum and plasma.
Total biiirubin in serum and plasma is the sum of unconjugated biiirubin (Bu), mono- and di-glucuronide conjugated biiirubin
(Be), and delta biiirubin (DELB), a biiirubin fraction covalently bound to albumin.
With the exception of anicteric jaundice, total serum biiirubin is invariably increased in jaundice. Causes of jaundice are
prehepatic, resulting from various hemolytic diseases; hepatic, resulting from hepatocellular injury or obstruction; and
posthepatic, resulting from obstruction of the hepatic or common bile ducts.'
The VITROS TBIL DT Slide method is performed using the VITROS TBIL DT Slide and the VITROS Chemistry Products
The VITROS TBIL DT Slide is a multilayered, analytical element coated on a polyester support. The analysis is based on a
modification of the classic diazo reaction.2
layer provides a reflective background for measuring the diazo products of biiirubin and contains all reagents necessary to
determine total biiirubin.
The method uses dyphylline to dissociate unconjugated biiirubin from albumin. Unconjugated biiirubin, conjugated biiirubin, and
albumin-linked biiirubin (delta) subsequently react with the diazonium salt 4-(A/-carboxymethylsulfonyl) benzenediazonium
hexafluorophosphate to produce azobilirubin chromophores that have similar molar absorptivities.
The change in reflection density is proportional to the total biiirubin concentration present in the sample.
Reaction Sequence
total biiirubin
(Bu, Be, and DELB)
dyphylline
[4-(A/-carboxymethylsulfonyl)-benzenediazonium hexafluorophosphate]
azobilirubin chromophores
Test Type and Conditions for TBIL DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-305
TBILDT
Total Bilirubin
Reagents
Reagents
Slide Diagram
Slide Ingredients
2
Dyphylline 0.5 mg and 4-(N-carboxymethylaminosulfonyl) benzene diazonium
hexafluorophosphate 57 ^g.
Other ingredients
~
Pigment, binders, buffer, mordant, surfactants and stabilizer.
•
4
• dyphylline
• diazonium salt
3. Reagent layer
• buffer, pH 3.0
4. Support layer
. 5
Slide Handling
Slide Preparation
IMPORTANT:
The slide must reach room temperature, 18 "-2B °C (64 °-82 °F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS TBIL DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for TBIL DT
Slides
Unopened
Storage Condition
Room temperature
18°-28°C(64 °-82° F)
Frozen
<-18°C (<0°F
Room temperature
18°-28°C(64 °-82°F)
Opened
Stability
<48 hours
<15 minutes
•
•
Serum
Plasma:4
Heparin
NOTE:
Do not use this slide for specimens from neonatal patients less than 14 days old.
Refer to "Limitations of the Procedure."
IMPORTANT:
Certain collection devices have been reported to affect other analytes and tests.s
Serum and Plasma
Patient Preparation
Pub. No. C-305
Version 1.0
TBIL DT
Testing Procedure
Total Bilirubin
Special Precautions
• Protect specimens from light.
• Direct exposure to sunlight is reported to cause as much as a 50% loss of serum bilirubin in one hour, especially when the
specimen is kept in capillary tubes.2
• Exposure to normal laboratory light can result in a significant loss of serum bilirubin after two to three hours.
WfiMUM(>
•
•
Specimen Storage and Stability for TBIL DT: Serum8
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C(64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<4 hours
<7 days
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products TBIL DT Slides
•
•
•
•
|
VITROS Chemistry Products 7% BSA or reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If total bilirubin concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's total bilirubin concentration.
|
Calibration
When to Calibrate
Calibrate:
Version 1.0
Pub. No. C-305
TBILDT
Total Bilirubin
Quality Control
The VITROS TBIL DT test may also need to be calibrated:
Calculations
each slide lot, total bilirubin concentration in unknown samples can be determined using the software-resident endpoint
a calibration.
Reportable (Dynamic) Range for TBIL DT
0.1-20.0
SI Units (umol/L)
2-342
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for total bilirubin are traceable to the Certified NIST
(National Institute of Standards and Technology) Reference Material, SRM" (Standard Reference Material) 916a. The
Ortho-Clinical Diagnostics (OCD) calibration laboratory uses SRM 916a to calibrate the NCCLS credentialed Jendrassik-Grof
method9 to support total bilirubin value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
WARNING:
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition'10 or other published guidelines.
I
IMPORTANT;
|
I
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other total bilirubin
methods if they:
•
Pub. No. C-305
Version 1.0
la
V|T
.S)
TBILDT
Total Bilirubin
Reference Interval
This reference interval is the central 95% of results from a study of 110 apparently healthy adults with normal liver enzymes
from a working population (85 females and 25 males).
Reference Interval for TBIL DT
0.2-1.3
SI Units (umol/L)
3-22
The VITROS DT60/DT60 II Chemistry System may be programmed to report total bilirubin results in conventional and SI units.
Reporting Units and Unit Conversion for TBIL DT
Conventional Units
mg/dL
SI Units
Known Interferences
The VITROS TBIL DT Slide method was screened for interfering substances following NCCLS Protocol EP7.11 The following
substances, when tested at the concentrations indicated, caused the bias shown.
Known Interfering Substances for TBIL DT
Interferent*
Levodopa
300 ng/mL**
300 ug/mL**
8 mg/dL
4-Aminosalicylic acid
8 mg/dL
Phenazopyridine
8 mg/dL
8 mg/dL
Biliverdin
4 mg/dL
4 mg/dL
100 mg/dL
Hemoglobin
200 mg/dL
400 mg/dL
100 mg/dL
200 mg/dL
400 mg/dL
100 mg/dL
200 mg/dL
. 400 mg/dL
*
**
Bilirubin Cone.
Conv. (mg/dL)
SI (Mmol/L)
0.4
7
(1.52mmol/L)**
17.8
304
(1.52mmol/L)**
0.4
(0.52 mmol/L)
7
(0.52 mmol/L)
17.6
301
(0.3 mmol/L)
0.4
7
(0.3 mmol/L)
17.4
298
0.3
5
(69 umol/L)
16.4
(69 umol/L)
280
0.5
9
(1 g/L)
0.5
9
(2 g/L)
9
0.5
(4 g/L)
10.5
180
(1 g/L)
10.5
180
(2 g/L)
10.5
180
(4 g/L)
15.0
257
(1 g/L)
15.0
257
(2 g/L)
15.0
257
(4 g/L)
Interferent
Concentration
Bias
Conv. (mg/dL)
SI
+1.4
-9.4
+0.4
+2.5
+3.8
+3.5
+0.5
+0.7
+0.1
+0.4
+1.3
-1.0
-1.2
-1.0
-1.2
-1.7
-1.9
(Mmol/L)
+24
-161
+7
+43
+65
+60
+9
+12
+2
+7
+22
-17
-21
-17
-21
-29
-32
This concentration may be present in the treatment of Parkinson's disease.
Other Limitations
•
•
•
Version 1.0
Accuracy of VITROS TBIL DT Slides results on specimens from neonates less than 14 days old has not been
demonstrated. Therefore, these specimens should be analyzed using VITROS NBIL DT Slides.
It is important to maintain consistency in bilirubin methodology. If VITROS NBIL DT Slides are initially used to monitor a
patient, continue to monitor that patient with VITROS NBIL DT Slides. Do not switch to VITROS TBIL DT Slides regardless
of the patient's age.
Results from the VITROS TBIL DT Slide may not be accurate at elevation greater than 6000 feet (approx. 1800 meters)
above sea level.
Pub. No. C-305
VITROS 0
TBIIDT
Total Bilirubin
Cefotiam (Pansporin) has been reported to show very large positive biases on VITROS TBIL DT Slide results.12 This drug
is normally cleared through the kidney. Biases will be largest in specimens from patients with renal insufficiency and may
be as large as 5 mg/dL (86 (.imol/L).
Drugs and other compounds that are diazo-reactive or that absorb light in the vicinity of 555 nm may interfere.
Certain drugs and clinical conditions are known to alter total bilirubin concentration in vivo. For additional information, refer
to one of the published summaries.1314
Method Comparison
I
using the Jendrassik-Grof comparative method, Doumas modification.9
Method Comparison for TBIL DT: Serum
Conventional Units
400
y =x
10
15
20
200
300
400
Comparative Method: Jendrassik-Grof Doumas Modification
(Mmol/L)
Comparative Method: Jendrassik-Grof Doumas Modification
(mg/dL)
Method Comparison for TBIL DT: Serum
n
DT60 II System vs.
comparative method
67
Correlation
Slope Coefficient
0.99
0.998
Range of
Sample Cone.
0.1-17.8
Pub. No. C-305
Intercept Sy.x
0.02
0.31
SI Units (Mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
2-304
0.38
5.30
Version 1.0
El VtTRtCpS
TBILDT
References
Total Bilirubin
Precision
Precision for TBIL DT: Serum
SI Units (umol/L)
Mean
Cone.
System
VITROS DT60 II
Within
Day SD*
Within
Lab SD**
Mean
Cone.
Within
Day SD*
Within
Lab SD**
Within
Lab
CV%**
No.
Observ.
No.
Days
1.3
0.06
0.07
23
1.0
1.2
5.1
88
22
13.3
0.18
0.23
227
3.1
3.9
1.7
88
22
References
1.
2.
3.
Routh Jl: Liver Function. In Tietz NW(ed). Fundamentals of Clinical Chemistry, ed 2. Philadelphia; WB Saunders; 1037; 1976.
4.
6. NCCLS. Procedures forthe Collection of Diagnostic Blood Specimens by Venipuncture. NCCLS Document H3. Wayne, PA: NCCLS;
1991.
7. NCCLS. Procedures forthe Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS;
1991.
9. Doumas B.T., Bayse D.D., et al. A candidate reference method for determination of bilirubin in serum. Test for transferability. Clin.
Chem. 29; 297-301; 1983.
12. Pickert A, Riedlinger I, Stumvill M. Interference of Cefotiam with Total Bilirubin Measured with the Ektachem Analyzer. Clin. Chem.
38:599-600; 1992.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Date (YYYY-MM-DD)
Lot Number
Tests
Number
Catalog Number or
Product Code
Attention: See
Version 1.0
X
Store At or Below
Store At or Above
Pub. No. C-305
Store Between
m
i
t
if
Use
Care.
Keep Dry
This end up
TBILDT
Revision History
Total Bilirubin
Revision History
Date of
Revision
2003-10-01
Version
1.0
New format
• Known interfering Substances - updated values; added hemoglobin;
changed 5-aminosalicylic acid to 4-aminosalicylic acid
• Method Comparison - updated all comparisons and the plots
• References - added all except 6,13,14
•
•
•
Signature
Obsolete Date
C€
REP
Mandeville House
62 The Broadway
Amersham
England
QihoClinical Diagnostics
company
© Ortho-Ciinical Diagnostics, Inc., 2003.
Pub. No. C-305
Version 1.0
[ Prodwcts
VITRII15
Chemistry!
THEO OT
VITROS Chemistry Products THEO DT Slides
Theophylline
Intended Use
VITROS THEO DT Slides quantitatively measure theophylline (THEO) concentration in serum and plasma.
Theophylline is a drug used in the treatment of asthma. Theophylline is an effective bronchodilator. The therapeutic and toxic
effects of theophylline are related to the plasma concentrations of the drug. Theophylline measurements are used to monitor
patient compliance and therapy and to diagnose potential overdose. Toxic effects include nausea, vomiting, diarrhea,
headache, tachycardia, arrhythmias, and convulsions.'
The VITROS THEO DT Slide method is performed using the VITROS THEO DT Slide and the VITROS Chemistry Products
DT Specialty Calibrator Kit on VITROS DT60/DT60 II Chemistry Systems.
The VITROS THEO DT Slide is a multilayered, analytical element coated on a polyester support. The assay is based on the
inhibition of beef liver alkaline phosphatase (ALKP) activity by theophylline, which acts as a potent uncompetitive inhibitor of
this isoenzyme.
p-Nitrophenyl phosphate (PNPP) migrates from the spreading layer to the reagent layer. If no theophylline is present, the
alkaline phosphatase reaction proceeds at its maximum rate. If theophylline is present, it uncompetitively inhibits the beef liver
isoenzyme, and the reaction rate is reduced. The assay is performed at pH 8.5 so that samples containing endogenous alkaline
phosphatase (maximum activity at pH 10.5) will not interfere. The product, p-nitrophenol, remains in the transparent reagent
layer.
The rate of change in reflection density is proportional to the theophylline concentration in the sample.
Reaction Sequence
p-nitrophenyl phosphate
beef liver ALKP
MgCI2
- > p-nitrophenol + H3PO4
Test Type and Conditions for THEO DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
2 minutes
Temperature
37°C (98.6°F)
Wavelength
400 nm
Sample Drop
Volume
10 ML
Version 1.0
Pub.
No. C-347
THEODT
Theophylline
Reagents
Reagents
Slide Diagram
Slide Ingredients
_
2
1
, 2
Alkaline phosphatase (beef liver, E.C.3.1.3.1) 0.02 U; magnesium chloride 3 ug;
and p-nitrophenyl phosphate 0.3 mg.
. 3
Other ingredients
Pigment, binders, surfactant, buffer, enzyme cofactor, protein, stabilizer and
cross-linking agent.
• p-nitrophenyl phosphate
3. Reagent layer
• ALKP
• buffer, pM 8.5
4. Support layer
- $
Slide Handling
Slide Preparation
IMPORTANT:
opened.
Do not use unopened slides that have been at room temperature, 18 - 2 8 'C
(64 °-82 °F) for >48 hours.
VITROS THEO DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for THEO DT
Slides
Storage Condition
Room temperature
Frozen
Room temperature
Unopened
Opened
18°-28°C (64°-82°F)
<-18°C (<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
Handle specimens as biohazardous
material.
•
•
Serum
Plasma:
Heparin
IMPORTANT:
•
Plasma 4
Substances that chelate magnesium such as:
EDTA
Citrate
Fluoride oxalate
Serum and Plasma
Patient Preparation
Pub. No. C-347
Version 1.0
THEO DT
Testing Procedure
Theophylline
Special Precautions
•
Storage
•
•
Specimen Storage and Stability for THEO DT: Serum and Plasma 7
Storage
Room temperature
Refrigerated
Frozen
Temperature
18°-28°C(64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
Stability
<7 days
<7 days
<60 days
Testing Procedure
Materials Provided
•
VITROS Chemistry Products THEO DT Slides
•
•
•
•
|
VITROS Chemistry Products 7% BSA or reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
analysis.
Sample Dilution
If theophylline concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's theophylline concentration.
I
Calibration
Version 1.0
Pub. No. C-347
THEODT
Theophylline
Quality Control
When to Calibrate
Calibrate:
• ' When critical system parts are replaced due to service or maintenance.
The VITROS THEO DT test may also need to be calibrated:
Calculations
Once a calibration has been performed for each slide lot, theophylline concentration in unknown samples can be determined
using the software-resident rate math model and the change in reflectance calculated for each unknown test slide.
a calibration.
Re portable (Dynamic) Range
Reportable (Dynamic) Range for THEO DT
Conventional Units (ug/mL)
1.0-40.0
SI Units (umol/L)
5.6-222.0
Values assigned to the VITROS Chemistry Products DT Specialty Calibrator Kit for theophylline are traceable to gravimetrically
prepared standards made from reagent grade theophylline. The Ortho-Clinical Diagnostics calibration laboratory uses the
gravimetrically prepared standard to calibrate an HPLC (High Performance Liquid Chromatography) method for theophylline8 to
support value assignment for the VITROS DT Specialty Calibrator Kit.
Quality Control
|
,
•
•
•
•
•
•
•<.
Analyze quality control materials in the same manner as patient samples, before or during patient sample processing. .
System.
Pub.
No. C-347
Version 1.0
THEO DT
Theophylline
Control materials other than VITROS DT Controls I & II may show a difference when compared with other theophylline
methods if they:
Quality-control and proficiency survey specimens that contain salicylate may show a positive bias compared with their
target theophylline concentrations. Refer to "Limitations of the Procedure."
Refer to the instructions for use for VITROS Chemistry Products DT Control I & I or to other manufacturer's product literature.
Reference Interval
This reference interval is based on an external study.10
Reference Interval for THEO DT
SI Units (umol/L)
55.5-111.0
10.0-20.0
Therapeutic range
In some cases the most effective therapeutic concentration may be outside this range. Monitor patients for efficacy of treatment
and for adverse symptoms.
The VITROS DT60/DT60 II Chemistry System may be programmed to report theophylline results in conventional and SI units.
Reporting Units and Unit Conversion for THEO DT
Conventional Units
ug/mL
SI Units
umol/L (ug/mL x 5.55)
Known Interferences
• Uremic specimens have shown positive biases of 3-5 ug/mL (17-28 umol/L) in the therapeutic range for theophylline.
The VITROS THEO DT Slide method was screened for interfering substances following NCCLS Protocol EP7.1' The
Known Interfering Substances for THEO DT
Interferent*
Salicylate
*
Interferent
Concentration
30mg/dL
(2.17 mmol/L)
700 U/L
Theophylline Concentration
SI (umol/L)
111
111
Conv. (ug/mL)
20
20
Bias
Conv. (ug/mL)
SI (pmol/L)
3.0
16.7
2.0
11.1
Other Limitations
Certain drugs and clinical conditions are known to alter theophylline concentration in vivo. For additional information, refer to
Version 1.0
Pub. No. C-347
THEO DT
Theophylline
Method Comparison
I
Method Comparison for THEO DT: Serum
Conventional Units
SI Units
y=X
.?u •
250
y =x
40 •
200
J*
?0«
J
20 •
10-
150
100
Q
o
so
0
0•
(0
20
30
50
40
50
(Mg/mL)
100
150
200
250
((Jmol/L)
Method Comparison for THEO DT: Serum
Conventional Units (ug'mL)
n
DT60 II System vs.
950 System
60
Correlation
Slope Coefficient
0.97
0.991
Range of
Sample Cone.
Intercept
0.6-37.9
1.31
SI Units (umol/L)
Sy.x
Range of
Sample Cone.
Intercept
Sy.x
1.37
3.5-210.5
7.27
7.62
Precision
Precision for THEO DT: Serum
System
VITROS DT60 II
Mean
Cone.
12.9
Within
Day SD*
0.49
21.7
0.67
Within
Lab SD**
0.65
0.93
SI Units (umol/L)
Mean
Cone.
71.3
Within
Day SD*
2.74
120.2
3.73
Within
Lab SD**
3.63
5.16
Within
Lab
CV%**
No.
Observ.
No.
Days
5.1
88
22
4.3
88
22
Pub. No. C-347
Version 1.0
THEO DT
References
Theophylline
References
1.
2.
3.
4.
5.
Kaplan L, PesceA. Clinical Chemistry: Theory, Analysis, and Correlation, ed. 2. CVMosby; 900; 1989.
1991.
6.
NCCLS. Procedures for the. Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS;
1991.
7. Clinical Laboratory Handbook for Patient Preparation and Specimen Handling. Fascicle IV: Therapeutic Drug Monitoring/Toxicology.
Skokie, IL: College of American Pathologists; 1985.
8. Lauff J. A Reference Procedure for the Determination of Theophylline and Related Xanthines in Serum by Dynamic Ion-Exchange HPLC.
J. Chrom. 417:99-109; 1987.
10. Hendele L, Weinberger MM. Theophylline Therapeutic Use and Serum Concentration Monitoring, in Taylor WJ and Finn AL (eds).
Individualizing Drug Therapy—Practical Applications of Drug Monitoring. New York: Gross, Townsend, Frank; 1:31-65; 1981.
NCCLS; 1995.
15. NCCLS. User Evaluation of Precision Performance with Clinical Chemistry Devices. NCCLS Document EP5. Wayne, PA: NCCLS; 1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date (YYYY-MM-DD)
| t t [ m$t> I
Vr7
V
Manufacturer
Store Between
Use
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Lot Number
Version 1.0
ml
Pub. No. C-347
VITFJCpS Q
THEODT
Theophylline
Revision History
Revision History
Date of
Revision
2003-10-01
Version
1.0
» New format
> Materials Required But Not Provided and
Sample Dilution - added VITROS 7% BSA; removed isotonic saline
> Limitations of the Procedure - updated values
> Method Comparison - updated all data and plots
Signature
Obsolete Date
C€
FU5P
Mandeville House
62 The Broadway
Amersham
England
Qtho-Clinical Diagnostics
company
Pub. No. C-347
Version 1.0
TPDT
VITROS Chemistry Products TP DT Slides
Total Protein
Intended Use
VITROS TP DT Slides quantitatively measure total protein (TP) concentration in serum and plasma.
Serum proteins transport drugs and metabolites and maintain plasma osmotic pressure. Most serum proteins are synthesized
in the liver, with the exception of gamma globulins. One of the most important serum proteins produced in the liver is albumin.
Total serum protein concentration can be used for evaluation of nutritional status.
Causes of high total serum protein concentration include dehydration, Waldenstrom's macroglobulinemia, multiple myeloma,
hyperglobulinemia, granulomatous diseases, and some tropical diseases. Total protein concentration is occasionally increased
in collagen diseases, lupus erythematosus, and other instances of chronic infection or inflammation. Causes of low total serum
protein concentration include pregnancy, excessive intravenous fluid administration, cirrhosis or other liver diseases, chronic
alcoholism, heart failure, nephrotic syndrome, glomerulonephritis, neoplasia, protein-losing enteropathies, malabsorption, and
severe malnutrition.1
The VITROS TP DT Slide method is performed using the VITROS TP DT Slide and the VITROS Chemistry Products
The VITROS TP DT Slide is a muitilayered, analytical element coated on a polyester support. The method of analysis is based
on the biuret reaction,2 which produces a violet complex when protein reacts with cupric ion (Cu*2) in an alkaline medium.
When the fluid penetrates the reagent layer, the reagent diffuses up to the spreading layer and reacts with protein. The reaction
between protein and copper tartrate takes place largely in the spreading layer where the protein is confined because of its high
molecular weight.
The amount of colored complex formed is proportional to the amount of total protein in the sample and is measured by
Reaction Sequence
protein + copper tartrate-
- > • colored complex
Test Type and Conditions for TP DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-310
TPDT
Reagents
Total Protein
Reagents
Slide Diagram
Slide Ingredients
1
2
2
Copper sulfate 0.9 mg; tartaric acid 1.2 mg; and lithium hydroxide 1.3 mg.
. 3
Other ingredients
Polymer beads, binders and surfactants.
4
3. Reagent layer
• copper sulfate
• tartaric acid
• lithium hydroxide
4. Support layer
5
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
opened.
(64 °-82 °F) for >48 hours.
1.
2.
VITROS TP DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for TP DT
Slides
Storage Condition
Unopened
Room temperature
Refrigerated
Frozen
Room temperature
Opened
18°-28°C (64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
" '
•
•
Serum
Plasma:4
Heparin
IMPORTANT:
•
Plasma:6
Fluoride oxalate
Serum and Plasma
Patient Preparation
• Patients should be recumbent; tourniquet application should be minimal.
Pub. No. C-310
Version 1.0
TPDT
Testing Procedure
Total Protein
Special Precautions
•
Storage
•
•
Specimen Storage and Stability for TP DT: Serum and Plasma6
Temperature
Stability
Storage
Room temperature
Refrigerated
Frozen
18°-28OC(64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<4 hours
<3 days
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products TP DT Slides
•
•
•
•
•
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT;
analysis.
Sample Dilution
If total protein concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's total protein concentration.
Calibration
.
When to Calibrate
Calibrate:
The VITROS TP DT test may also need to be calibrated:
Version 1.0
Pub. No. C-310
TPDT
Total Protein
Quality Control
Calculations
each slide lot, total protein concentration in unknown samples can be determined using the software-resident endpoint
a calibration.
Reportable (Dynamic) Range for TP DT
Conventional (g/dL)
2.0-11.0
SI Units (g/L)
20-110
I
I
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for total protein are traceable to the Certified
NIST (National Institute of Standards and Technology) Reference Material, SRM' (Standard Reference Material) 927c.
The Ortho-Clinical Diagnostics calibration laboratory uses SRM" 927c to calibrate the NCCLS credentialed Biuret method9 to
support total protein value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
WARNING:
•
•
•
•
•
•
System.
I
I
IMPORTANT;
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other total protein
methods if they:
•
Pub. No. C-310
Version 1.0
TPDT
Total Protein
Reference Interval
population (56 females and 69 males). No significant differences between results from the male and female populations were
observed.
Reference Interval for TP DT
6.3-8.2
SI Units (g/L)
63-82
The VITROS DT60/DT60 II Chemistry System may be programmed to report total protein results in conventional and SI units.
Reporting Units and Unit Conversion for TP DT
Conventional Units
SI Units
g/dL
g/L (g/dL x 10.0)
Known Interferences
The VITROS TP DT Slide method was screened for interfering substances following NCCLS Protocol EP7.11 The substances
Known Interfering Substances for TP DT
Interferent*
Hemoglobin
*
Interferent
Concentration
200 mg/dL
400 mg/dL
(2 g/L)
(4 g/L)
Total Protein Concentration
Conv. (g/dL)
SI (g/L)
7
70
7
70
Bias
Conventional
3%
9%
SI
3%
9%
Other Limitations
Results from plasma samples may be up to 4% higher than those from serum.12
Certain drugs and clinical conditions are known to alter total protein concentration in vivo. For additional information, refer to
Version 1.0
Pub. No. C-310
TPDT
Total Protein
Method Comparison
I
Method Comparison for TP DT: Serum
SI Units
Conventional Units
150
10 •
x•
100
6
>
4 "
Q
CO
2 •
s
50
0
0
2
4
6
8
10
12
150
100
50
(g'L)
(9'dL)
Method Comparison for TP DT: Serum
Conventional Units (g'dL)
DT60 II System vs.
comparative method
n
Correlation
Slope Coefficient
49
0.97
0.995
Range of
Sample Cone.
2.2-10.7
Intercept Sy.x
0.10
0.24
SI Units (g/L)
Range of
22-107
1.04
2.39
Precision
Precision was evaluated with quality control materials on the VITROS DT60 II System following NCCLS Protocol EP5.1S
Precision for TP DT: Serum
System
VITROS DT60 II
Mean
Cone.
3.7
6.7
Within
Day SD*
0.09
Within
Lab SD**
0.11
0.16
0.20
Mean
Cone.
37
67
SI Units (g/L)
Within
Within
Day SD* Lab SD**
0.9
1.1
1.6
2.0
Within
Lab
CV%**
3.1
2.9
No.
Observ.
No.
Days
88
88
22
22
Pub. No. C-310
Version 1.0
[•I vi~rFij
TPDT
Total Protein
References
References
1.
2.
TietzNW(ed). Fundamentals of Clinical Chemistry, ed. 3. Philadelphia: WB Saunders; 314-324; 1987.
Kingsley GR. The Direct Biuret Method for Determination of Serum Proteins as Applied to Photoelectric and Visual Coiorimetry. J. Lab.
Clin. Med. 27:840-845; 1942.
3. NCCLS. Protection of Laboratory Workers from Instrument Biohazards and Infectious Diseases Transmitted by Blood, Body Fluids and
4.
1991.
1991.
9. Doumas BT, et al. A Candidate Reference Method for Determination of Total Protein in Serum: 1. Development and Validation. Clin.
Chem. 27:1642-1650; 1981.
12. Tietz NW. Textbook of Clinical Chemistry. Philadelphia: WB Saunders; 487; 1986.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Use
Lot Number
Tests
Care.
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Date (YYYY-MM-DD)
Attention: See
Version 1.0
â
| EC I REP [
I
Store At or Above
Pub. No. C-310
TPDT
Revision History
Total Protein
Revision History
Date of
Revision
2003-10-01
Version
1.0
> New format
> Specimens Not Recommended - added section
> Known Interfering Substances table - removed dextran, updated hemoglobin
> Method Comparison - updated data for all comparisons and plots
> Precision - updated values
References - added all
Signature
Obsolete Date
C€
Mandeville House
62 The Broadway
Amersham
England
company
Pub. No. C-310
Version 1.0
P rodu cts
Chemistry
TRIG DT
VITROS Chemistry Products TRIG DT Slides
Triglycerides
Intended Use
VITROS TRIG DT Slides quantitatively measure triglycerides (TRIG) concentration in serum and plasma.
Triglycerides, fatty acid esters of glycerol, represent the major form of fat found in the body; their primary function is to store
and provide cellular energy. The concentration of triglycerides in the plasma at any given time is a balance between the rates of
entry and removal. Triglyceride concentrations in the plasma vary with age and gender. Moderate increases occur during
growth and development. Triglycerides are used for the evaluation of hyperlipidemias; high concentrations may occur with
hypothyroidism, nephrotic syndrome, glycogen storage diseases, and diabetes mellitus. Extremely high triglyceride
concentrations are common in acute pancreatitis.1
The VITROS TRIG DT Slide method is performed using the VITROS TRIG DT Slide and the VITROS Chemistry Products
The VITROS TRIG DT Slide is a multilayered, analytical element coated on a polyester support. The analysis is based on an
enzymatic method as described by Spayd et al.2
Triton X-100 surfactant in the spreading layer aids in dissociating the triglycerides from lipoprotein complexes present in the
sample. The triglyceride molecules are then hydrolyzed by lipase to yield glycerol and fatty acids. Glycerol diffuses to the
reagent layer, where it is phosphorylated by glycerol kinase in the presence of adenosine triphosphate (ATP). In the presence
of L-a-glycerol-phosphate oxidase, L-a-glycerophosphate is then oxidized to dihydroxyacetone phosphate and hydrogen
peroxide. The final reaction involves the oxidation of a leuco dye by hydrogen peroxide, catalyzed by peroxidase, to produce
a dye.
The density of the dye formed is proportional to the triglyceride concentration present in the sample and is measured by
Reaction Sequence
->•
lipoproteins
lipase
triglycerides + H2O
^- glycerol + fatty acids
glycerol kinase
glycerol + ATP
MgCI2
L-a-glycerophOSphate + O 2
L-a-glycerol-phosphate oxidase
peroxidase
H2O2 + leuco dye
triglycerides + proteins
^ dihydroxyacetone phosphate + H2O2
->• dye + 2H2O
Test Type and Conditions for TRIG DT
Test Type
Colori metric
Version 1.0
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Pub. No. C-303
Temperature
37°C (98.6°F)
Wavelength
555 nm
Sample Drop
Volume
10 uL
TRIG DT
Triglycerides
Reagents
Slide Diagram
Slide Ingredients
Triton X-100
lipase
3. Reagent layer
buffer, pH 8.0
glycerol kinase
ATP
L-a-glycerophosphate
oxidase
peroxidase
leuco dye
4. Support layer
2
Lipase (Candida rugosa, E.C.3.1.1.3) 0.15 U; peroxidase (horseradish root,
E.C.1.11.1.7) 0.52 U; glycerol kinase (Cellulomonas sp., E.C.2.7.1.30) 0.35 U;
L-a-glycerophosphate oxidase (Pediococcus sp., E.C.1.1.3.-) 0.19 U; Triton X-100
0.62mg;2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4-dimethylaminophenyl)
imidazole (leuco dye) 0.04 mg; and adenosine triphosphate 0.14 mg.
Other ingredients
Pigment, binders, buffer, surfactants, stabilizers, scavenger, enzyme cofactors, dye
Slide Handling
Slide Preparation
IMPORTANT;
The slide must reach room temperature, 18 "-28 °C (64 °-82 °F), before the wrapper is
opened.
(64°-82°F) for >48 hours.
1.
2.
Remove the individual slides from the box.
VITROS TRIG DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for TRIG DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°~46°F)
Frozen
s-18°C(<0°F)
Room temperature
18°-28°C (64°-82° F)
Slides
Unopened
Opened
Stability
<48 hours
<15 minutes
I
•
•
*
Serum
Plasma:
Heparin
Serum is the specimen of choice because it is the basis for the US National Institutes of Health recommendations relating
lipid levels with cardiac risk. Heparin plasma results have been reported as being within 1 % of serum results.4
Pub. No. C-303
Version 1.0
TRIGDT
Testing Procedure
Triglycerides
•
Plasma:
EDTA"
Serum and Plasma
Collect specimens using standard laboratory procedures.6 '
Patient Preparation
• Collect specimens from patients fasting for at least 12 Hours.8
Special Precautions
• Equipment must be soap-free and glycerol-free.
• Do not use collection tubes with glycerol-lubricated stoppers.
• Centrifuge specimens and remove the serum and plasma from the cellular material within 4 hours of collection.9
Storage
•
•
Specimen Storage and Stability for TRIG DT: Serum and Plasma9
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
IMPORTANT;
18°-28°C(64°-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<3 days
<7 days
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products TRIG DT Slides
•
•
•
•
•
.
I
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
IMPORTANT:
Bring all fluids and samples to room temperature, 18°-28°C (64°~82°F), prior to
analysis.
Sample Dilution
If triglycerides concentrations exceed the system's reportable (dynamic) range:
1. Dilute with VITROS 7% BSA, isotonic saline, or reagent-grade water.
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's triglycerides concentration.
Version 1.0
Pub. No. C-303
TRIGDT
Triglycerides
Calibration
Calibration
When to Calibrate
Calibrate:
The VITROS TRIG DT test may also need to be calibrated:
Calculations
I
each slide lot, triglyceride concentration in unknown samples can be determined using the software-resident endpoint
a calibration.'
Reportable (Dynamic) Range for TRIG DT
15-400
SI Units (mmol/L)
0.17-4.52
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for triglyceride are traceable to the CDC chromotropic
acid reference procedure.10 The Ortho-Clinical Diagnostics (OCD) calibration laboratory uses value assigned human serum
pools, from a CDC Reference network Certified Laboratory, to calibrate a glycerol phosphate oxidase triglyceride
spectrophotometric method11 to support triglyceride value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
,
•
•
•
•
System.
Pub. No. C-303
Version 1.0
TRIG DT
Triglycerides
•
•
and Definitions; Approved Guideline-Second Editionu or other published guidelines.
IMPORTANT:
•
•
compatibility with this test before using for quality control,
Control materials other than VITROS DT Controls I & II may show a difference when compared with other triglycerides
methods if they:
Reference Interval
These reference intervals are recommended by NCEP.13
Reference Interval for TRIG DT
Conventional Units
(mg/dL)
Normal
Borderline High
High
Very High
SI Units
(mmol/L)
<150
<1.69
150-199
1.69-2.25
200-499
2.26-5.64
>500
>5.65
The VITROS DT60/DT60 II Chemistry System may be programmed to report triglycerides results in conventional and SI units.
Reporting Units and Unit Conversion for TRIG DT
Conventional Units
mg/dL
.
SI Units
Known Interferences
•
Free glycerol14
Free (nonesterified) glycerol in serum is measured along with the glycerol from the hydrolysis of triglycerides and
diglycerides. Certain clinical conditions (e.g., diabetes mellitus and cardiac ischemia) show high endogenous free glycerol
levels. Some drugs used in the treatment of lipemia also produce elevated glycerol levels. Triglyceride results from
samples of such patients will not reflect actual serum triglyceride content.
Other Limitations
Certain drugs and clinical conditions are known to alter triglyceride concentration in vivo. For additional information, refer to one
of the published summaries.1516
Version 1.0
Pub. No. C-303
TRIG DT
Triglycerides
Method Comparison
I
using the Enzymatic Total Glycerol comparative method."
Method Comparison for TRIG DT: Serum
Conventional Units
500
SI Units
y =x
400
300
I
S
200
D
W
o
Q
1
100
100
200
300
400
1-
500
Comparative Method: Enzymatic Total Glycerol
(mmol/L)
Comparative Method: Enzymatic Total Glycerol
(mg/d/L)
Method Comparison for TRIG DT: Serum
n
DT60 II System vs.
comparative method
36
Correlation
Slope Coefficient
1.00
Range of
Sample Cone.
40-394
0.987
Intercept Sy.x
1.84
15.92
SI Units (mmol/L)
Range of
Sample Cone.
Intercept
Sy.x
0.45-4.45
0.02
0.18
Precision
Precision for TRIG DT: Serum
System
VITROS DT60 II
Within
Within
Day SD* Lab SD**
2.0
2.8
Mean
Cone.
110
265
3.4
6.1
SI Units (mmol/L)
Mean
Within
Within
Cone.
Day SD* Lab SD**
1.24
0.02
0.03
2.99
0.04
0.07
Within
Lab
CV%**
No.
Observ.
2.6
84
21
2.3
84
21
No.
Days
Pub.
No. C-303
Version 1.0
TRIG DT
References
Triglycerides
References
1.
2.
3.
4.
5.
6.
7.
Spayd R, et al. Multilayer Film Elements for Clinical Analysis. Clin. Chem. 24:1348-1350; 1978.
Cholesterol Education Program. NIH publication no. 90-2964:26-27; 1990.
1991.
1991.
8.
Cholesterol Education Program. NIH publication no. 90-2964:28-29; 1990.
10. ColeTG, Klotzach SG, McNamara JR. Measurement of Triglyceride Concentration, Rifai N, Warnick GR, DominiczakMK (eds).
Handbook of Lipoprotein Testing, ed. 2. Washington DC: AACC Press, 207-219; 2000.
11. Fossati P, Prencipe L. Clin. Chem. 28:2077-2080; 1982.
13. NCEP. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of
High Blood Cholesterol in Adults (Adult Treatment Panel III); Executive Summary. NIH Publication No. 01-3670. National
Institutes of Health. Bethesda. Maryland: May, 2001.
14. Stein EA, et al. National Cholesterol Education Program Recommendations for Triglyceride Measurement: Executive Summary. Clin.
Chem. 41:1421-1426; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
REF
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Care.
Number
Keep Dry
Store At or Below
This end up
Catalog Number or
Product Code
Attention: See
Version 1.0
t
Store At or Above
Pub. No. C-303
TRIGDT
Triglycerides
Revision History
Revision History
Date of
•Revision
2003-04-30
Version
1.0
> New format
> Specimen Collection and Preparation - removed statement regarding grossly
lipemic specimens
> Reference Interval - updated all values
> Method Comparison - updated all data and the plot
> References - added all but number 9
Obsolete Date
Signature
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REP I
Mandeville House
62 The Broadway
Amersham
England
u^cfMww company
Pub. No. C-303
Version 1.0
Products
VIHTRB
Chemistry
urCR DT
VITROS Chemistry Products urCR DT Slides
Urine Creatinine
Intended Use
VITROS urCR DT Slides quantitatively measure creatinine concentration in urine.
Urinary creatinine excretion is a function of lean body mass in normal persons and shows little or no response to dietary
changes. Since urinary creatinine is excreted mainly by glomerular filtration, with only small amounts due to tubular secretion, a
24-hour urine creatinine and a serum creatinine measurement can be used to calculate creatinine clearance, which is an
estimate of the glomerular filtration rate.
Exercise may cause an increased creatinine clearance. The creatinine clearance rate is unreliable if the urine flow is low.
The VITROS urCR DT Slide method is performed using the VITROS urCR DT Slide and the VITROS Chemistry Products
The VITROS urCR DT Slide is a multilayered, analytical element coated on a polyester support.
A drop of diluted patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying
layers. Creatinine diffuses to the reagent layer, where it is hydrolyzed to creatine in the rate-determining step. The creatine is
converted to sarcosine and urea by creatine amidinohydrolase. The sarcosine, in the presence of sarcosine oxidase, is
oxidized to glycine, formaldehyde, and hydrogen peroxide. The final reaction involves the peroxidase-catalyzed oxidation of a
leuco dye to produce a colored product. The rate of change in reflection density is proportional to the concentration of
creatinine in the sample.
Reaction Sequence
creatinine + H2O
creatine amidinohydrolase
creatine + H2O sarcosine + O2 + H 2 O
H2O2 + leuco dye
—
sarcosine oxidase
peroxidase
->•
creatine
->•
sarcosine + urea
glycine + formaldehyde + H2O2
dye + 2H2O
Test Type and Conditions for urCR DT
Test Type
Rate
VITROS DT60/DT60 II
Module
DTSC/DTSC II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
680 nm
Sample Drop
Volume
10 uL
Version 1.0
Pub. No. C-373
VITFj[Cp*S El
urCR DT
Urine Creatinine
Reagents
Reagents
Slide Diagram
Slide Ingredients
—— -
-
"'
Creatinine amidohydrolase (Flavobacterium sp., E.C.3.5.2.10) 0.20 U; creatine
amidinohydrolase {Flavobacterium sp., E.C.3.5.3.3) 4.7 U; sarcosine oxidase
(Bacillus sp., E.C.1.5.3.1) 0.55 U; peroxidase (horseradish root, E.C.1.11.1.7)
1.6 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis(4-dirnethylaminophenyl)
imidazole (leuco dye) 32 jig.
~
„-
Other ingredients
•- 4
-
'
3. Reagent layer
• creatine amidinohydrolase
» sarcosine oxidase
peroxidase
leuco dye
> buffer, pH 7.0
4. Support layer
5. -ower slide mount
Pigment, binders, surfactants, stabilizer, scavenger, chelator, buffer, dye
Slide Handling
CAUTION:
Slide Preparation
IMPORTANT:
opened.
(64 "-82 °F) for >48 hours.
1.
2.
VITROS urCR DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for urCR DT
Storage Condition
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
Room temperature
18°-28°C (64°-82°F)
Slides
Unopened
Opened
Stability
<48 hours
<4 weeks
<15 minutes
WARNING:
•
Urine
IMPORTANT:
Urine
•
•
Keep refrigerated until analysis.
Patient Preparation
Special Precautions
• Urine specimens must be pretreated prior to processing. Refer to "Specimen Pretreatment" for instructions.
Pub. No. C-373
Version 1.0
urCR DT
Specimen Pretreatment
Urine Creatinine
Specimen Storage and Stability for urCR DT: Urine4
Temperature
Storage
18°-28OC(64O-82°F)
Room temperature
2°-8°C (36°-^6°F)
Refrigerated
Frozen
<-18°C (<0°F)
Stability
<3 days
<5 days
<lndefinite
Specimen Pretreatment
Urine
Predilution
1. Mix 1 part sample with 20 parts of reagent-grade water.
2. Analyze.
3. Multiply the results by 21 to obtain the creatinine concentration in the original urine sample.
For example:
1. Fill a 100 mL graduated cylinder with 60 mL reagent-grade water.
2. Add a 3.0 mL aliquot of well mixed urine specimen to the graduated cylinder. The 3 mL pipette used to reconstitute
VITROS DT Calibrators can be used to measure the 3 mL.
3. Cover the graduated cylinder and mix well.
Testing Procedure
Materials Provided
•
VITROS Chemistry Products urCR DT Slides
•
•
•
•
Quality control materials
Reagent-grade water
VITROS DT Pipette
•
sJNT:
analysis.
Sample Dilution
If urine creatinine concentrations exceed the system's reportable (dynamic) range or if the analyzer displays an L-11 error
code:
1. Mix 1 part prediluted sample with 1 part reagent-grade water.
2. Reanalyze.
3. Multiply the results by 42 to obtain an estimate of the creatinine concentration in the original sample.
Calibration
Version 1.0
Pub. No. C-373
V/|T"Rj|CpfS El
nrCRDT
Urine Creatinine
Quality Control
When to Calibrate
Calibrate:
The VITROS urCR DT test may also need to be calibrated:
Calculations
Once a calibration has been performed for each slide lot, urine creatinine concentration in unknown samples can be
determined using the software-resident rate math model and the change in reflectance calculated for each unknown test slide.
a calibration.
Reportable (Dynamic) Range for urCR DT
1.05-346.5*
SI Units (umol/L)
92.8-30630.6*
'After multiplying by a dilution factor of 21.
(National Institute of Standards and Technology) Reference Material, SRM1*' (Standard Reference Material) 914a. The
Ortho-Clinical Diagnostics calibration laboratory, uses SRM 914a to calibrate selected measurement procedures, including an
HPLC (High Performance Liquid Chromatography)5 method and a rate Jaffe6 method, to support creatinine value assignment
Quality Control
|
WARMING:
•
•
•
System.
•
•
•
Pub. No. C-373
Version 1.0
El v/| " r .s^P"^
urCRDT
Urine Creatinine
•
•
•
Urine controls often contain high creatine levels and may give an L-11 error codes.
For urine specimens, use commercially available urine control materials.
Refer to the manufacturer's product literature.
Reference Interval
population (67 subjects).
Reference Interval for urCR DT
24-hour
*
**
Conventional Units
800-2800 mg/day*
SI Units
7000-25000 umol/day**
Creatinine concentration (mg/dL) x 24-hour volume (dL) = mg/day.
Creatinine concentration (|jmol/L) x 24-hour volume (L) = |jmol/day.
The VITROS DT60/DT60 II Chemistry System may be programmed to report urine creatinine results in conventional and
SI units.
Reporting Units and Unit Conversion for urCR DT
Conventional Units
mg/dL
SI Units
Known Interferences
None identified.
Other Limitations
of the published summaries.8 9
Version 1.0
Pub. No. C-373
urCR DT
Urine Creatinine
Method Comparison
I
using the HPLC comparative method.5 Testing followed NCCLS Protocol EP9.10
Method Comparison for urCR DT: Urine
Conventional Units
SI Units
40000
400
I
300 •
30000
=
200
20000
O
o:
100
100
.300
200
10000
400
10000
(mg/dL)
30000
20000
40000
(pmol/L)
Method Comparison for urCR DT: Urine
n
DT60 II System vs.
comparative method
76
Correlation
Slope Coefficient
1.00
0.999
Range of
Sample Cone.
Intercept
9.0-323.4
-0.05
SI Units ((jmol/L)
Sy.x
Range of
Sample Cone.
Intercept
Sy.x
4.06
798-28589
-4.39
358.50
Precision
Precision was evaluated with quality control materials on the VITROS DT60 II System following NCCLS Protocol EP5.1' The
data presented are a representation of test performance and are provided as a guideline. Variables such as sample handling
and storage, reagent handling and storage, laboratory environment, and system maintenance can affect reproducibility of test
results.
Precision for urCR DT: Urine
System
VITROS DT60 II
Within
Within
Mean
Cone.
Day SD* Lab SD**
3.19
3.56
153.9
49.8
1.36
1.73
SI Units (umol/L)
Mean
Within
Within
Cone.
Day SD* Lab SD**
13606
281.6
314.6
4405
119.8
152.5
Within
Lab
cv%**
No.
Observ.
No.
Days
2.3
88
22
3.5
88
22
Pub. No. C-373
Version 1.0
urCR DT
References
Urine Creatinine
References
1.
4.
5.
6.
7.
NCCLS. Urinalysis and Collection, Transportation, and Preservation of Urine Specimens; Approved Guideline. NCCLS Document
GP16. Wayne, PA: NCCLS; 1995.
Ambrose RT, Ketchum DF, Smith JW. Creatinine Determined by "High Performance" Liquid Chromatography. Clin. Chem. 29: 256-259;
1983.
Jaffe M. Uber den Niederschlag welchen Pikrinsaure in normalen Ham erzeugt und uber eine neue Reaktion des Kreatinins. Z Physiol
Chem. 10: 391-400; 1886.
Friedman RB, Young DS. Effects of Disease on Clinical Laboratory Tests. Washington, D.C.: AACC Press; 1990
9.
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Use
Lot Number
Tests
Number
Catalog Number or
Product Code
Store At or Below
Attention: See
Version 1.0
X
Store At or Above
Pub. No. C-373
I
Care.
Keep Dry
ffl
This end up
VITRCpS 0
WCR DT
Urine Creatinine
Revision History
Revision History
Date of
Revision
2003-10-01
> New format
• Specimen Pretreatment - added section
> Method Comparison - updated all data and plots
> References - added all except 8, 9,10,11
Version
1.0
Signature
Obsolete Date
C€
TEC
I
REP
I
Mandeville House
62 The Broadway
Amersham
England
ôtowon company
Pub. No. C-373
Version 1.0
P r o d u cts
Chem i str y
URIC OT
VITROS Chemistry Products URIC DT Slides
Uric Acid
Intended Use
VITROS URIC DT Slides quantitatively measure uric acid (URIC) concentration in serum and plasma.
Uric acid is the end product of purine metabolism. Elevations of uric acid occur in renal failure, prerenal azotemia, gout, lead
poisoning, excessive cell destruction (e.g., following chemotherapy), hemolytic anemia, and congestive heart failure and after
myocardial infarction. Uric acid is also increased in some endocrine disorders, acidosis, toxemia of pregnancy, hereditary gout,
and glycogen storage disease type I. A low uric acid concentration may be found following treatment by some drugs (e.g., lowdose aspirin), with low dietary intake of purines, in the presence of renal tubular defects, and in xanthinuria.1
The VITROS URIC DT Slide method is performed using the VITROS URIC DT Slide and the VITROS Chemistry Products
The VITROS URIC DT Slide is a multilayered, analytical element coated on a polyester support. The method is similar to those
described by Kageyama2 and Trivedi et al. 3
A drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. Uric
acid from the sample migrates to the reagent layer, where it is oxidized in the presence of uricase to form allantoin and
hydrogen peroxide. Hydrogen peroxide oxidzes a leuco dye in the presence of peroxidase to generate a colored dye. The
reflection density of the dye is measured by reflectance spectrophotometry.
Reaction Sequence
->•
2H2O + uric acid
peroxidase
H2O2 + leuco dye
—>.
allantoin + H2O2 + CO2
dye + 2H2O
Test Type and Conditions for URIC DT
Test Type
Colorimetric
VITROS DT60/DT60 II
Module
DT60/DT60 II
Approximate
Incubation Time
5 minutes
Temperature
37°C (98.6°F)
Wavelength
660 nm
Sample Drop
Volume
10 ML
Version 1.0
Pub. No. C-302
URIC DT
Uric Acid
Reagents
Reagents
Slide Diagram
Slide Ingredients
2. Spreading layer
2
3. Reagent layer
• uricase
• peroxidase
• leuco dye
• buffer at pH 8.7
4. Support layer
Uricase {Candida utilis, E.C.1.7.3.3) 0.02 U; peroxidase (horseradish root, E.C.1.11.1.7)
0.6 U; and 2-(3,5-dimethoxy-4-hydroxyphenyl)-4,5-bis-(4-dimethylaminophenyl)
imidazole (leucodye) 14 ug.
Other ingredients
Stabilizers, pigment, binders, buffer, surfactants, dye solubilizer, scavenger and crosslinking agent.
Slide Handling
Slide Preparation
The slide must reach room temperature, 18 "-28 °C (64 °-82 °F), before the wrapper is
opened.
(64 °-82 °F) for >48 hours.
1.
2.
V\farm the unopened slide for 15 minutes. Unopened slides that remain in the sealed wrapper may be returned to
VITROS URIC DT Slides are stable until the expiration date on the carton when they are stored and handled as specified.
Slide Storage and Stability for URIC DT
Storage Condition
Slides
Unopened
Room temperature
18°-28°C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Frozen
<-18°C(<0°F)
Opened
Room temperature
18°-28°C (64°-82°F)
Stability
<48 hours
<15 minutes
|
I
• Serum
• Plasma:6
IMPORTANT:
Heparin
Serum and Plasma
Patient Preparation
Special Precautions
• Centrifuge specimens and remove the serum and plasma from the cellular material within 4 hours of collection.5
Pub. No. C-302
Version 1.0
URIC DT
Testing Procedure
Uric Acid
Storage
•
•
Specimen Storage and Stability for URIC DT: Serum and Plasma9
Storage
Temperature
Stability
Room temperature
Refrigerated
Frozen
18O-28°C(64O-82°F)
2°-8°C (36°-46°F)
<-18°C(<0°F)
<3 days
<5 days
<6 months
Testing Procedure
Materials Provided
•
VITROS Chemistry Products URIC DT Slides
•
•
•
•
.
Isotonic saline
Reagent-grade water
VITROS DT Pipette
•
I
IMPORTANT:
analysis.
Sample Dilution
If uric acid concentrations exceed the system's reportable (dynamic) range:
2. Reanalyze.
3. Multiply the results by the dilution factor to obtain an estimate of the original sample's uric acid concentration.
|
Calibration
When to Calibrate
Calibrate:
The VITROS URIC DT test may also need to be calibrated:
Version 1.0
Pub. No. C-302
URIC DT
Uric Acid
Quality Control
Calculations
each slide lot, uric acid concentration in unknown samples can be determined using the software-resident endpoint colorimetric
a calibration.
Reportable (Dynamic) Range for URIC DT
0.3-16
SI Units (Mtnol/L)
18-952
Values assigned to the VITROS Chemistry Products DT Calibrator Kit for uric acid are traceable to the Certified NIST (National
Institute of Standards and Technology) Reference Material, SRM® (Standard Reference Material) 913a.
The Ortho-Clinical Diagnostics calibration laboratory uses SRM^giSa to calibrate the CDC Uricase method10 to support
uric acid value assignment for the VITROS DT Calibrator Kit.
Quality Control
|
WARNING:
•
•
•
•
•
•
System.
and Definitions; Approved Guideline-Second Edition" or other published guidelines.
I
i
IMPORTANT:
•
Control materials other than VITROS DT Controls I & II may show a difference when compared with other uric acid
methods if they:
- Contain high concentrations of preservatives, stabilizers, or other nonphysiological additives,
•
Pub. No. C-302
Version 1.0
URICDT
Uric Acid
Reference Interval
The serum reference interval is the central 95% of results from a study of 3880 apparently healthy males and a study of
272 apparently healthy females.
Reference Interval for URIC DT
Male
Female
Conventional Units
(mg/dL)
3.5-8.5 mg/dL
2.5-6.2 mg/dL
SI Units
((jmol/L)
208-506 umol/L
149-369 umol/L
The VITROS DT60/DT60 II Chemistry System may be programmed to report uric acid results in conventional and SI units.
Reporting Units and Unit Conversion for URIC DT
Conventional Units
mg/dL
SI Units
Known Interferences
•
Hydralazine is used as an antihypertensive agent. Interference tests show hydralazine causes approximately 16% negative
bias in serum per 1.0 mg/dL of hydralazine.
The VITROS URIC DT Slide method was screened for interfering substances following NCCLS Protocol EP7.12 The
|
Known Interfering Substances for URIC DT
Interferent*
Gentisic acid
*
Interferent
Concentration
5 mg/dL
(0.32 mmol/L)
Uric Acid Concentration
SI (umol/L)
Conv. (mg/dL)
10
59
Average Bias
Conventional and SI
-22%
Other Limitations
Certain drugs and clinical conditions are known to alter uric acid concentration in vivo. For additional information, refer to one of
the published summaries. 13 ' u
Version 1.0
Pub. No. C-302
INSTRUCTIONS FOR OSE
URIC DT
Uric Acid
Method Comparison
I
The plots and table show the results of a comparison of samples analyzed on the VlTROS DT60 II System with those analyzed
using the VlTROS 950 System. Testing followed NCCLS Protocol EP9.15
Method Comparison for URIC DT: Serum
Conventional Units
SI Units
y =x
1000
18 •
3
15"
|
12 "
I
i
9
800
600
D
W
s
400
6 '
200
3 '
0
0 0
12
15
18
200
400
600
800
1000
(mg/dL)
Method Comparison for URIC DT: Serum
n
DT60 II System vs.
950 System
58
Correlation
Slope Coefficient
1.03
0.999
Range of
1.0-14.8
-0.08
0.16
SI Units (umol/L)
Range of
Sample Cone.
Intercept
Sy.x
62-878
-4.69
9.75
Precision
Precision was evaluated with quality control materials on VlTROS the DT60 II System following NCCLS Protocol EP5.16
Precision for URIC DT: Serum
SI Units ((jmol/L)
System
VlTROS DT60 II
Mean
Cone.
4.3
Within
Day SD*
0.04
11.9
0.11
Within
Lab S D "
0.08
0.23
Mean
Cone.
257
707
Within
Day SD*
2.5
6.3
Within
Lab SD**
4.7
13.4
Within
Lab
CV%**
1.8
1.9
No.
Observ.
No.
Days
88
22
88
22
Pub. No. C-302
Version 1.0
[•] VITROS
URIC DT
References
Uric Acid
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
Kageyama N. A Direct Colorometric Determination of Uric Acid in Serum and Urine with Uricase-Catalysts System. Clin. Chem. Acta.
31:421; 1971.
Trivedi RC, Rabar L, Berta EN, et al. New Enzymatic Method for Serum Uric Acid at 500 nm. Clin. Chem. 24:1908-191; 1978.
1991.
NCCLS. Procedures forthe Collection of Diagnostic Blood Specimens by Skin Puncture. NCCLS Document H4. Wayne, PA: NCCLS;
1991.
Schultz AL. Uric Acid. In: Pesce AJ, Kaplan LA, eds. Methods in Clinical Chemistry, St. Louis: The CV Mosby Company; 27-34; 1987.
NCCLS. Statistical Quality Control for Quantitative Measurements: Principles and Definitions; Approved Guideline-Second Edition..
NCCLS; 1995.
1992.
Glossary of Symbols
Glossary of Symbols
®
2
Date (YYYY-MM-DD)
LOT
Lot Number
Number
SN
~l
Version 1.0
ml
Do Not Reuse
[ REFJ
Catalog Number or
Product Code
A
Attention: See
[
EC
1 REF
w
IVD
X
1
Manufacturer
JjT
r"'T!"1
Store Between
LJ-iJ Use
I
I
Care.
*t*
Keep Dry
Store At or Below
jtt1
This end up
Tests
Store At or Above
Pub. No. C-302
VITRCflS Q
URICDT
Uric Acid
Revision History
Revision History
Date of
Revision
2003-08-11
*
Version
1.0
» New format
> Pre-dilution Procedure - changed distilled water to reagent-grade water
• Limitations of the Procedure - added hydralazine and gentisic acid
> Method Comparisons - updated all comparisons and plots
» References - added all
Obsolete Date
Signature
C€
Mandeville House
62 The Broadway
Amersham
England
^Je&Mtm company
Pub. No. C-302
Version 1.0
I Products
VITRCD5
Chemistry!
DT Calibrator Kit
DT Calibrator
Intended Use
VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST,
TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, CI", CO2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3,
PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.
Reagents
The VITROS DT Calibrators are prepared from bovine serum albumin and processed bovine serum to which enzymes,
electrolytes, stabilizers, preservatives and other organic analytes have been added. Enzymes added to the product and their
sources are shown below:
Enzymes Added to the Product and the Enzyme Sources
Source
Porcine Heart
Porcine Kidney
Porcine Pancreas
Porcine Heart
Porcine Heart
Porcine Kidney
Chicken Heart
Porcine Pancreas
Enzymes Added to Bovine Serum Base Pool
(ALT)
(ALKP)
(AMYL)
Amylase
(AST)
(CK)
Creatine Kinase
(GGT)
(LDH)
(LIPA)
Lipase
VITROS DT Calibrator Diluents are prepared from processed water to which inorganic salts have been added.
Nominal Values and Traceability
Nominal values are representative target concentrations used during the calibrator manufacturing process. The particular
Supplementary Assigned Value (SAV) for an analyte in each vial is generation specific for VITROS Chemistry Products DT
Slides, and is provided on the VITROS Chemistry Products Calibration Data Module (CDM) installed on the VITROS DT
Chemistry System. Refer to the analyte specific Instructions For Use for additional calibration information.
Nominal Values Used for the Manufacture of VITROS Chemistry Products DT Calibrator Kit
Analyte
Albumin
Ammonia
Amylase
Total Bilirubin
Blood Urea Nitrogen
Calcium
Carbonate
Chloride
Cholesterol
Creatine Kinase
Creatinine
Gamma Glutamyl Transferase
Glucose
HDL Cholesterol
Iron
Lactate
Lipase
Version 3.0
Calibrator 1*
1.3(13.0)
62
20
0(0)
20
22
0.8(13.7)
4(1.4)
3.4 (0.85)
8.0
70
45(1.16)
45
0.3 (27)
15
35(1.94)
__
10(1.79)
0.2
275
45
Calibrator 2*
3.5 (35.0)
400
270
596 (350)
150
257
11.0(188.1)
27 (9.6)
9.0 (2.25)
36
145
145 (3.75)
525
7.0(619)
235
200(11.10)
—
170(30.45)
3.0
750
275
Pub. No. J23110 EN
Calibrator 3*
—
—
—
170(100)
970
—
20.0 (342)
92 (32.8)
14.0 (3.49)
—
—
390(10.09)
—
4.2(371)
—
445 (24.70)
—
—
11.5
—
—
Calibrator 4*
6.0 (60.0)
1500
900
128 (75)
—
850
—
—
—
—
—
—
1700
13.2(1167)
1400
—
15(0.38)
490 (87.76)
—
1790
1900
Units (SI)
g/dL (g/L)
U/L
U/L
ug/dL (umol/L)
U/L
U/L
mg/dL (umol/L)
mg/dL (mmol/L)
mg/dL (mmol/L)
mmol/L
mmol/L
mg/dL (mmol/L)
U/L
mg/dL (Mmol/L)
U/L
mg/dL (mmol/L)
mg/dL (mmol/L)
ug/dL (umol/L)
mmol/L
U/L
U/L
DT Calibrator
Magnesium
0.7 (0.29)
6.5 (2.69)
2.6(1.08)
—
Potassium
10.0
1.8
—
Phosphorus
1.0(0.32)
5.0(1.61)
—
Sodium
100
200
Total Protein
2.0 (20.0)
10.8(108.0)
5.9 (59.0)
Triglycerides
30 (0.34)
135(1.52)
350 (3.95)
Uric Acid
1.3(77.3)
15.0(892.2)
7.5(446.1)
•Concentration is when calibrator is reconstituted with 3.0 mL of corresponding diluent.
MOTE:
—
—
12.5(4.04)
—
—
—
—
mg/dL (mmol/L)
mmol/L
mg/dL (mmol/L)
mmol/L
q/dL(g/L)
mg/dL (mmol/L)
mg/dL (Mmol/L)
For those analytes that are not targeted in a calibrator bottle a dash is used.
Traceability of Values Assic ned to the VITROS Chemistry Products DT Calibrator Kit
Analyte
Reference Material
Albumin
NIST SRM 927c
Not Applicable
Not Applicable
Ammonium Sulfate**
Ammonia
Not Applicable
Amylase
Not Available
Total Bilirubin
NIST SRM 916a
Blood Urea Nitrogen
NIST SRM 912a
Calcium
NIST SRM 915a
NIST SRM 192b
CO2
NIST SRM 919a
Chloride
NIST SRM 911b
Cholesterol
Not Available
Creatine Kinase
NIST SRM 914a
Creatinine
Gamma Glutamyl Transferase
Not Available
Glucose
NIST SRM 917b
HDL Choleseterol
NIST SRM 911b
Iron
NIST SRM 937
Lactate
Lactic Acid, L (+) **
Not Applicable
Lipase
Not Available
NIST SRM 929
Magnesium
Potassium
NIST SRM 918a
NIST SRM 200
Phosphorus
Sodium
NIST SRM 919a
Total Protein
NIST SRM 927c
Triglycerides
Assigned Human Serum
NIST SRM 913a
Uric Acid
NBIL
NIST SRM 916a
urCR
NIST SRM 914a
** Reagent-grade commercial preparation
Reference Method
Bromcresol Green 1
IFCC/37C J
IFCC/NRSCL RS4-A/37C 3
Enzymatic/37CA
PG5/37C 5
IFCC/NRSCL RS2-A/37C 6
Jendrassik-Grof7 8
CDC (Urease/GLDH) 9
Atomic Absorption 10
Thermal Conductivity
Coulometry 11
Abell-Kendall12
IFCC/NRSCL RS14-P/37C "
HPLC "/Jaffe 15
IFCC/NRSCL RS17-P/37C 16
AACC/CDC (Hexokinase/G6PDH)17
Dextran Sulfate/Enzymatic 1S
NCCLS/Ferenedye 1920
HPLC 21
NCCLS/P->L/37C22
pH Stat 2i
Flame Atomic Absorption M
Flame Photometer
Phosphomolybdate/p-semidine HCI 2S
Flame Photometer2'
Biuret28
CDC chromotropic acid 29/unblanked
Uricase/UV30
HPLC 31
HPLC "/Jaffe 1S
While these products are bovine in origin, they should be handled using the same precautions as with any other blood or bloodderived product.
. .
'
The packaging (vial stopper) of this product contains dry natural rubber, which
may cause allergic reactions in some individuals.
Pub. No. J23110 EN
Version 3.0
DT Calibrator
Reconstitution
First Aid
Inhalation - Remove to fresh air. Seek medical advice. Skin - Wash skin after each contact with plenty of soap and water. Get
medical attention if skin is cut or punctured. E y e - Immediately flush eyes with plenty of water for at least 15 minutes and get
me.dical attention. Ingestion - Drink 1-2 glasses of water. Seek medical advice.
Transportation
Reconstitution
NOTE:
Each bottle of calibrator lyophilate has a corresponding diluent labeled by number.
Use the appropriate diluent in the reconstitution of the lyophilate.
1. Materials should be at room temperature before constitution. Vials should sit out at room temperature approximately 30
minutes if stored in the refrigerator, or 60 minutes if stored in the freezer.
2. Slowly invert the diluent bottle several times to mix the contents thoroughly. DO NOT SHAKE.
3. Gently tap the lyophilate vial on the counter several times to dislodge any material adhering to the stopper.
4. Remove the seal and stopper from each bottle just prior to the addition of the diluent. Do not leave vials unstoppered.
5. Add exactly 3.0 mL of the appropriate diluent to each lyophilate vial.
fiOTE;
Use a clean, dry pipette for each vial. A Class A volumetric pipette, or an automated pipette of equivalent accuracy, is
recommended because of the importance of this reconstitution procedure to the accuracy of the results. Discard any
remaining diluent.
6. Replace the stopper and hold it firmly in place. Invert the vial gently. DO NOT SHAKE. Reconstitution time is typically 10
minutes using a rotator or rocker. Manual reconstitution, with occasional inversion, may take up to 30 minutes.
Visually verify that all freeze-dried material is dissolved prior to use.
7. Keep all fluids tightly stoppered when not in use. At the time of reconstitution, it is recommended the operator date and
initial the vial.
8. Reconstituted product should be used immediately or stored in the refrigerator between 2-8°C (36-46°F) to maximize
stability.
Storage
Calibration Kit Storage and Stability for DT Calibrator Kit
DT Calibrator Kit
Unopened
Reconstituted
Frozen
Refrigerated
Refrigerated
Storage Condition
<-18°C (<0°F)
2°-8°C (36°-46°F)
.
2°-8°C (36°-46°F)
Stability
<100 days if tightly stoppered
<24 hours if tightly stoppered
Refer to the analyte specific Instructions for Use for special calibration precautions.
Materials Provided
•
•
3 vials each of lyophilized calibrator 1,2,3 and 4.
3 vials each of calibrator diluent 1, 2, 3 and 4 containing 5 mL.
Materials Required, But Not Provided
A Class A volumetric pipette or an automated pipette of equivalent accuracy for the addition of diluent to lyophilate.
Version 3.0
Pub. No. J23110 EN
V I T R ^ D S [Sg
DT Calibrator
Test Procedure
Test Procedure
NOTE;
For HDLC calibration, do not pretreat calibrators with VITROS Chemistry Products
HDL Reagent Tubes.
NOTE;
1.
Remove reconstituted material stored in the refrigerator.
2.
Mix vial thoroughly by gently inverting several times.
3.
Place a portion of fluid in a cup and cap the cup.
4.
Restopper the vial and immediately return it to the refrigerator.
5.
Bring the cup to room temperature before analysis (approximately 15 minutes).
6.
Analyze according to calibration instructions found in the Operator's Manual.
7.
Discard any unused portion in the cup following testing.
8.
Discard the calibrators after 24 hours.
The commutability of the VITROS Chemistry Products DT Calibrator Kit for the analytes listed above has been demonstrated
among the VITROS DT Chemistry Systems. Commutability of this calibrator has not been established with other methods.
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
4
DoumasBT, Biggs HG. Determination of serum albumin. Standard methods of clinical chemistry\972; 7:175-188.
Bretaudiere JP, Vassault A, et al. Criteria for establishing a standardized method for determining alkaline phosphatase activity in human serum.
Clin. Chem. 1977; 23:2263-74.
Bergmeyer HV, Horder M, Rej R. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part
3, IFCC method for alanine aminotransferase (EC 2.6.1.2). Clin. Chem. Clin. Biochem. 1986; 24:481-95.
Bruce WA, Leiendecker CM, Freier EF. Two-Point Determination of Plasma Ammonia with the Centrifugal Analyzer. Clin. Chem. 24:782; 1978.
Mauck LA. A Kinetic colorimetric method for the determination of total amylase activity in serum. Clin. Chem. 31:1007; 1985.
Bergmeyer HV, Horder M, Rej R. Approved recommendation on IFCC methods for the measurement of catalytic concentration of enzymes. Part
2, IFCC method for aspartate aminotransferase. J Clin. Chem. Clin. Biochem. 1986; 24:497-510.
Jendrassik L, Grof P. Vereinfachte photometrische Methoden zur bestimmung des blutbilirubin. Biochem Z1938; 297: 81-89.
Doumas BT, Perry BW, Sasse EA, et al. Standardization in Bilirubin Assays: Evaluation of Selected Methods and Stability of Bilirubin Solutions.
Clin. Chem. 19:984-993; 1973.
Sampson EJ, et al. A coupled-enzyme equilibrium method for measuring urea in serum: optimization and evaluation of the AACC study group on
urea candidate reference method. Clin. Chem. 1980; 26:816-26.
Cali JP, et al. Atomic Absorption. NBS Reference Method (modified). Clin. Chem. 19:1208; 1987.
Velapoldi RA, Paule RC, Schaffer R, Mandel TJ, Gramlich JW. Standard reference materials: a reference method for the determination of chloride
in serum. National Institute of Standards and Technology Special Publication 260-67, Washington, DC, 1979.
Abell L I , Levy BB, Brodie BB, Kendall RB. A Simplified Method for the Estimation of Total Cholesterol in Serum and Demonstration of its
Specificity. J S/o/. Chem., 1952; 195: 357-366.
Scandinavian Committee on Enzymes. Recommended Method for the Determination of Creatine Kinase in Blood. Scand. J Clin. Lab. Invest.
36:711-23; 1976; ibid., 39:1-5: 1979.
Ambrose RT, Ketchum DF, Smith JW. Creatinine Determined by "High Performance" Liquid Chromatography. Clin. Chem. 29:256-259; 1983.
Jaffe M. Uber den Niederschlag welchen Pikrinsaure in normalen Harn erzeugt und uber eine neue Reaktion des Kreatinins. Z Physiol Chem
1886; 10:391-400.
Evans DS, Kringle RO. G-Glutamyltransferase: Response surface co-optimization of reaction conditions with g-Glutamyl-3-carboxy-4-nitroanilide
as the substrate. Clin. Chem. 27:1036; 1981.
Neese, J.W., Duncan, P., Bayse, D.D. etal, Development and evaluation of a hexokinase/glucose-6-phosphatedehydrogenase procedure for use
as a national glucose reference method. HEW Publication No. (CDC) 77-8330. HEW. USPHS, Centers for Disease Control, 1976.
National Committee for Clinical Laboratory Standards. Determination of Serum Iron and Total Iron-Binding Capacity; Proposed Standard. NCCLS
Publication H17-P. Villanova, PA, NCCLS, 1990.
ICSH. Revised Recommendations for the Measurements of the Serum Iron in Human Blood. British Journal of Hemotology. 75:616; 1990.
Smith JW, Ambrose RT. Determination of Lactic Acid in Human Serum by Ion Exchange Chromatography. Internal Eastman Kodak Company
Report. 1982.
Buhl SN, Jackson KY, Graffunder B. Optimal reaction condition for assaying human lactate dehydrogenase pyruvate-to-lactate at 25, 30 and
37°C. Clin. Chem. 1978; 24: 261-6.
Tietz NW, Repique EV. Proposed Standard Method for Measuring Lipase Activity in Serum by a Continuous Sampling Technique. Clin. Chem.
19:1268-1275; 1973.
Kaplan L, Pesce A. Clinical Chemistry: Theory, Analysis, and Correlation. CV Mosby, 1069; 1984.
Pub. No. J23110 EN
Version 3.0
Glossary of Symbols
DT Calibrator
25. Velapoldi RA, et al. A reference method for the determination of potassium in serum. NIST Special Publication 260-63, US Department of
Commerce, National Institute of Standards and Technology, Gaithersburg, MD, 1978.
26. Dryer RL, Tamnes AR, Routh J L The Determination of Phosphorus and Phosphatase with N-Phenyl-p-phenyienediamine. J. Biol. Chem.
222:177; 1957. AACC Proposed Selected Method.
27. Velapoldi RA, et al. A reference method for the determination of sodium in serum. NIST Special Publication 260-60, US Department of
Commerce, National Institute of Standards and Technology, Gaithersburg, MD, 1978.
28. Doumas BT, Bayse DD, Carter RJ, et al. A candidate reference method for determination of total protein in serum. I. Development and
validation. Clin Chem 1981; 27:1642-50.
29. Cole T.G., Klotzach S.G. and McNamara J.R. Measurement of Triglyceride Concentration. In: Handbook of Lipoprotein Testing, 2nd edition, Rifai
N., Warnick G.R. and Dominiczak M.K., Eds. AACC Press, Washington, 2000, pp 207-219.
30. Duncan, P., Gochman, N., Cooper, G, et al, Development and Evaluation of a Candidate Reference Method for Uric Acid in Serum, 1979, CDC,
US Dept. of HHS, Atlanta, GA.
31. Ferris R. Immunoaffinity pretreatment method for improved chromatographic determination of fractionated biiirubin (Abstract). Clin Chem 1987;
33: 1012.
Glossary of Symbols
The Glossary of Symbols table defines the symbols used on the VITROS Chemistry Products packaging and on the
VITROS Chemistry Products Assay Sheets.
Glossary of Symbols
Do Not Reuse
Date
(Year-Month-Day)
Tests
Lot Number
Device
Serial Number
Catalog Number or
Product Code
Attention: See
Manufacturer
Version 3.0
X
X
X
f
f
§
Fragile, Handle with Care
Keep Dry
This end up
Xi
Store At or Below
Store At or Above
Store Between
Pub. No. J23110 EN
X
Irritant
procedures
VITR^S Q
DT Calibrator
Revision History
Revision History
Date of
Revision
2004-03-31
Version
3.0
New format, technically equivalent to 905660h with the following minor
changes:
• Updated Glossary of Symbols table
2004-02-29
2.0 (905660h)
•
•
•
2003-01-31
1.0
•
•
•
•
•
•
•
•
•
Storage-Removed "IMPORTANT: For Creatine Kinase only: Once
reconstituted, calibrators should be used immediately. Calibrators can be
used within 6 hours if stored between 2-8°C (36-46°F)."
TEST PROCEDURE-Removed "For Creatine Kinase: Calibrators can be
used within 6 hours if stored between 2-8°C (36-46°F)."
Values assigned to calibrators-HDL Cholesterol
Added names of calibrators used for calibrating individual tests
Added SI Units in the nominal values table
Added reference materials and methods table
Added Note under Reconstitute section
Reworded title to Test Procedure
Added information about Creatine Kinase storage
Added Limitations section
Added References section
Added Glossary of Symbols, Revision History, signature block, CE mark,
and authorized representative information
Signature
Obsolete Date
C€
EC
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
4efcHfeM company
Pub. No. J23110 EN
Version 3.0
j Products
VITRCD5
Chemistry I
DT Isoenzyme Calibrator Kit
DT Isoenzyme Calibrator
Intended Use
VITROS DT Isoenzyme Calibrator Kit is specially formulated for use as calibrators for CKMB on Vitros DT Chemistry Systems.
Reagents
VITROS DT Isoenzyme Calibrators are prepared from bovine serum albumin to which human heart tissue CKMB, inorganic
salts, stabilizers and preservatives have been added. VITROS DT Isoenzyme Calibrator Diluents are prepared from processed
water.
Nominal values are representative target concentrations used during the calibrator manufacturing process. The calibrator
values used for calibrating CKMB are generation specific for VITROS Chemistry Products DT Slides and are provided on the
VITROS Product Calibration Data Module (CDM) installed on the analyzer. Refer to the analyte specific Instructions for Use for
additional calibration information.
Nominal Values Used for the Manufacture of VITROS Chemistry Products DT Isoenzyme Calibrator Kit
Calibrator 2*
Calibrator 1*
Calibrator 4*
Units
Analyte
CKMB
5
50
275
U/L
"Concentration is when calibrator is reconstituted with 3.0 mL of corresponding diluent
Traceability of Values Assigned to the VITROS Chemistry Products DT Isoenzyme Calibrator Kit
The values assigned to the VITROS Chemistry Products DT Isoenzyme Calibrator Kit are traceable to a
CK-MB immuno-inhibition method, with residual CK-B activity quantified using the Scandinavian Committee on Enzymes
recommended method for total CK. 1
HANDLE AS IF CAPABLE OF TRANSMITTING DISEASE. This product is
prepared from bovine serum albumin to which human tissue extracts have been
added. The tissue donors used in preparation of the product have been tested
and found to be nonreactive for hepatitis B surface antigen (HBsAg), antibody to
HCV, and antibody to HIV using FDA approved methods. However, since no test
can offer complete assurance that infectious agents are absent, this product
should be handled following the recommendations in NCCLS Guideline M29 2 or
other published biohazard safety guidelines. This product should be handled
using the same precautions as with any other blood or blood-derived product.
WAF
Absorb spilled material in vermiculite or other suitable absorbents, sweep up and dispose of with clinical waste. Disinfect area
Version 2.0
Pub. No. J23112 EN
Reconstitution
First Aid
Inhalation - Remove to fresh air. Seek medical advice. Skin - Wash skin after each contact with soap and plenty of water. Get
medical attention if skin is cut or punctured. Eye - Immediately flush eyes with plenty of water for at least 15 minutes and get
medical attention. Ingestion -Drink 1-2 glasses of water. Seek medical advice.
Transportation
Reconstitution
NOTE:
1. Materials should be at room temperature before reconstitution. Vials should sit out approximately 60 minutes at room
temperature when taken from freezer storage.
5. Add exactly 3.0 ml_ of the appropriate diluent to each vial.
NOTE;
Use a clean, dry pipette for each vial. A Class A volumetric pipette, or an automated pipette of equivalent accuracy is
remaining diluent.
6. Replace stopper and hold it firmly in place. Invert the vial gently. DO NOT SHAKE. Reconstitution time is less than 10
minutes using a rotator or rocker. Manual reconstitution, with occasional inversion, may take up to 30 minutes. Visually
verify that all freeze-dried material is dissolved prior to use.
initial vial.
stability.
Storage
Calibration Kit Storage and Stability for DT Isoenzyme Calibrator Kit
Storage Condition
Calibration Kit
Unopened
Frozen
<-18°C (S0°F)
Reconstituted
Refrigerated
2°-8°C (36°-46cF)
Exposure to light must be minimized to preserve creatine kinase.
Refer to the analyte specific Instructions for Use for special calibration precautions.
Stability
Materials Provided
•
•
4 vials each of lyophilized calibrator 1, 2 and 4.
4 vials each of calibrator diluent 1, 2 and 4 containing 5 mL.
Pub. No. J23112 EN
Version 2.0
Test Procedure
Test Procedure
1.
2.
3.
4.
5.
6.
7.
8.
Mix vial thoroughly by gentle inversion. DO NOT SHAKE.
Analyze according to instructions found in the Operator's Manual.
Discard reconstituted material after 24 hours.
The commutability of the VITROS Chemistry Products DT Isoenzyme Calibrator Kit for CK-MB has been demonstrated only for
VITROS DT Chemistry Systems. Commutability of this calibrator has not been established with other CK-MB methods.
References
1.
Scandinavian Committee on Enzymes. Recommended Method for the Determination of Creatine Kinase in Blood. Scand. J. Clin. Lab. Invest.
2.
36:711; 1976.
Glossary of Symbols
Chemistry Products Assay Sheets
Glossary of Symbols
• Do Not Reuse
Date
(Year-Month-Day)
Tests
^f*
Keep Dry
Lot Number
Device
Iff
This end up
SN
Serial Number
Store At or Below
Irritant
REF
Catalog Number or
Product Code
Store At or Above
procedures
Attention: See
Manufacturer
Version 2.0
V
W
I
x
Store Between
Pub. No. J23112 EN
Revision History
Revision History
Date of
Revision
2004-02-29
Version
2.0
2003-01-31
1.0(905659g)
New format, technically equivalent to 905659g with the following minor
changes:
• Added SI Units to the Nominal Values table
• Add information about traceability
• Added reference to NCCLS
• Reworded Precautions to match carton
• Add note in Reconstitution section
• Changed wording to Test Procedures
• Further defined Materials Required but Not Provided
• Added Limitations section
• Added References section
• Added Glossary of Symbols, Revision History, signature block, CE mark,
Obsolete Date
Signature
C€
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
Pub. No. J23112 EN
Version 2.0
I Products
viTRms
Chemi stry E
DT Specialty Calibrator Kit
DT Specialty Calibrator
Intended Use
VITROS DT Specialty Calibrator Kit is specially formulated for use as calibrators for CHE, Li and THEO on VITROS DT
Chemistry Systems.
Reagents
VITROS DT Specialty Calibrators are prepared from processed human serum to which cholinesterase from equine serum,
lithium chloride, theophylline, electrolytes, organic analytes, stabilizers and preservatives have been added.
VITROS DT Specialty Calibrator Diluents are prepared from processed water to which inorganic salts have been added.
Nominal values are representative target concentrations used during the calibrator manufacturing process. The calibrator
values used for calibrating CHE, Li and THEO are generation specific for VITROS Chemistry Products DT Slides and are
provided on the VITROS Chemistry Products Calibration Data Module (CDM) installed on the VITROS DT Chemistry System.
Refer to the analyte specific Instructions for Use for additional calibration information.
Nominal Values Used for the Manufacture of VITROS Chemistry Products DT Specialty Calibrator Kit
Analyte
Cholinesterase (CHE)
Lithium (Li)
Theophylline (THEO)
Calibrator 1*
0.00 (0)
0.2
1.5(8.33)
Calibrator 2*
5.00 (5000)
Calibrator 4*
12.30(12300)
1.5
4.0
10.0(55.50)
35.0(194.25)
Conv. Units/(SI Units)
U/mL (U/L)
mmol/L
ug/mL (umol/L)
"Concentration is when calibrator is reconstituted with 3.0 mL of corresponding diluent.
Traceability of Values Assic ned to the VITROS Chemistry Products DT Specialty Calibrator Kit
Analyte
Cholinesterase (CHE)
Lithium (Li)
Theophylline (THEO)
Reference Material
Not Applicable
SRM 924a
Theophylline*
Reference Method
Butyrylthiocholine/ferricyanide '
Atomic Absorption 2
HPLC
•Reagent grade commercial preparation
Warning
prepared from human serum and human enzymes. Each donor unit used in
preparation of the product was tested and found to be nonreactive for hepatitis
B surface antigen (HBsAg), antibody to HCV, and antibody to HIV using FDA
approved methods. However, since no test can offer complete assurance that
infectious agents are absent, this product should be handled following the
recommendations in NCCLS Guideline M294 or other published biohazard
safety guidelines.
Warning:
Version 2,0
Pub. No. J23115 EN
\/ITF?Cp"S El
Reconstitution
Absorb spilled material in vermiculite or other suitable absorbents, sweep up and dispose of with clinical waste! Disinfect area
First Aid
medical attention if skin is cut or punctured. E y e - Immediately flush eyes with plenty of water for at least 15 minutes and get
medical attention. Ingestion - Drink 1-2 glasses of water. Seek medical advice.
Transportation
Reconstitution
Note:
1.
Materials should be at room temperature before reconstitution.
Vials should sit out approximately 30 minutes if stored in the refrigerator, or 60 minutes if stored in the freezer.
2. Slowly invert the diluent vial several times to mix the contents thoroughly. DO NOT SHAKE.
3. Gently tap the lyophilate on the counter several times to dislodge any material adhering to the stopper.
5. Add exactly 3.0 mL of the appropriate diluent to each vial.
Note:
Use a clean, dry pipette for each vial. A Class A volumetric pipette, or an automated pipette of equivalent accuracy, is
remaining diluent.
minutes using a rotator or rocker. Manual reconstitution, with occasional inversion, may take up to 30 minutes. Visually
verify that all freeze-dried material is dissolved prior to use.
initial the vial.
stability.
Storage
Calibration Kit Storage and Stability for PT Specialty Calibrator Kit
DT Specialty
Calibrator Kit
Unopened
Reconstituted
Refrigerated
Frozen
Refrigerated
Storage Condition
2°-8°C (36°-46°F)
<-18°C(<0°F)
2°-8°C (36°-46°F)
Stability
Refer to the analyte specific Instructions for Use for special calibration precautions..
Materials Provided
•
•
4 vials each of lyophilized calibrator 1, 2 and 4.
4 vials each of calibrator diluent 1,2 and 4 containing 5 mL.
Pub. No. J23115 EN
Version 2.0
Test Procedure
Test Procedure
1.
2.
3.
4.
5.
6.
7.
8.
Mix vial thoroughly by gently inverting several times. DO NOT SHAKE.
Analyze according to calibration instructions found in the Operator's Manual.
Discard reconstituted material after 24 hours.
The commutability of the VITROS Chemistry Products DT Specialty Calibrator Kit for the analytes listed above has been
demonstrated among the VITROS DT Chemistry Systems. Commutability of this calibrator has not been established with other
cholinesterase, lithium or theophylline methods.
References
1.
2.
3.
4.
Method recommended by the "Working Group on Enzymes of the German Society for Clinical Chemistry," European Journal of Clinical Chemistry,
Clinical Biochemistry. 30:163-170; 1992.
A Reference Method of Determination of Lithium in Serum. U.S. Dept. of Comm., NBS Publication 260-69.
Lauff J. A Reference Procedure for the Determination of Theophylline and Related Xanthines in Serum by Dynamic Ion-Exchange HPLC. J.
Chrom. 417:99-109; 1987.
Glossary of Symbols
Glossary of Symbols
Version 2.0
Do Not Reuse
Manufacturer
Store Between
Date (YYYY-MM-DD)
Consult Instructions
for Use
Lot Number
Tests
Care.
n i l
OlM
Number
Keep Dry
Catalog Number or
Product Code
Store At or Below
This end up
Attention: See
Store At or Above
Pub. No. J23115 EN
Revision History
Revision History
Date of
Revision
2004-02-29
Version
2.0
2003-01-31
1.0(906294g)
New format, technically equivalent to 906294g with the following minor
changes:
• Added SI'Units in the nominal values table
• • Added reference materials and methods table
• Update Precautions to match package labels
• Added Note under Reconstitution section
• Reworded title to Test Procedure
• Added Limitations section
• Added References section
Obsolete Date
Signature
C€
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
êfHWOM company
Pub. No. J23115 EN
Version 2.0
Products
VITROD5
Chemistry
VITROS Chemistry Products DT Controls
DT Controls
Intended Use
VITROS DT Control is designed for use in monitoring the performance of VITROS DT Chemistry Systems.
Reagents
VITROS DT Control is prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives and
other organic analytes have been added.
Enzymes Added to the Product and the Enzyme Sources
Source
Enzymes Added to Human Serum Base Pool
Amylase
Cholinesterase
Creatine Kinase
Lipase
Porcine Heart
Porcine Kidney
Porcine Pancreas
Porcine Heart
Human Serum
Porcine Heart
Bovine Kidney
Chicken Heart
Porcine Pancreas
VITROS DT Control Diluent is manufactured from processed water to which inorganic salts have been added.
WARNING:
ING;
HANDLE AS IF CAPABLE OF TRANSMITTING DISEASE.
This product is prepared front human serum. Each donor unit used in the
preparation of the product has been tested and found to be nonreactive for
hepatitis B surface antigen (HBsAg), antibody to HCV, and antibody to HIV using
FDA approved methods. However, since no test can offer complete assurance
that infectious agents are absent, this product should be handled following the
recommendations made in NCCLS Guideline M29' or other published biohazard
safety guidelines. This product should be handled using the same precautions
as with any other blood or blood-derived product.
First Aid
medical attention if skin is cut or punctured. Eye-Immediately flush eyes with plenty of water for at least 15 minutes and get
Version 2.0
Pub. No. J23111 EN
VI~TF;IJ]S El
DT Controls
Reconstitution
Transportation
Reconstitution
NOTE;
1.
2.
3.
4.
5.
6.
7.
8.
Each bottle of control has a corresponding diluent labeled by number. Use the
appropriate diluent in the reconstitution of the lyophilate.
Materials should be at room temperature before reconstitution. Vials should sit out approximately 30 minutes if stored in the
refrigerator, or 60 minutes if stored in the freezer.
Slowly invert the diluent bottle several times to mix the contents thoroughly. DO NOT SHAKE.
Gently tap the lyophilate vial on the counter several times to dislodge any material adhering to the stopper.
Remove the seal and stopper from each bottle just prior to the addition of the diluent. Do not leave vials unstoppered.
Add exactly 3.0 ml_ of the appropriate diluent to each vial. Use a clean, dry pipette for each vial. A Class A volumetric
pipette, or an automated pipette of equivalent accuracy is recommended because of the importance of this reconstitution
procedure to the accuracy of the results. Discard any remaining diluent.
Replace stopper and hold it firmly in place. Invert the vial gently. DO NOT SHAKE. Reconstitution time is typically 10
Keep all control fluids tightly stoppered when not in use. At the time of reconstitution, it is recommended the operator date
and initial vial.
Reconstituted product should be used immediately or stored in the refrigerator between 2-8°C (36-46°F) to maximize
stability.
Storage
Storage and Stability for VITROS DT Control
Storage Condition
<-18°C (<0°F)
2°-8°C (36°-46°F)
Reconstituted
2°-8°C (36°-46°F)
'Refer to the Assay Sheet for analyte-specific stability information.
DT Control
Unopened
Frozen
Refrigerated
Refrigerated
Stability
<6 months
Store tightly stoppered*
Exposure to light will affect bilirubin and creatine kinase results.
Ammonia concentration increases with time.
Materials Provided
•
•
12 vials of lyophilized control.
12 vials of diluent containing 5 mL each.
Procedure
After reconstitution, the control serum should be assayed in the same manner as a patient sample. The reported values can
then be compared with those given on the assay sheet.
NOTE;
1.
2.
3.
4.
5.
6.
7.
8.
Mix thoroughly by gently inverting several times. DO NOT SHAKE.
Discard reconstituted control after 7 days.
Pub.
No. J23111 EN
Version 2.0
Assay Values
DT Controls
Assay Values
•
The assay values for VITROS DT Control can be found on the assay sheet specific for the lot number. Be sure that the lot
number on the control assay sheet is the same as the lot number printed on the label of the vial being used. The intervals
of acceptable values are intended for use only with the VITROS DT Chemistry Systems.
If separate generation-specific ranges are listed, use the appropriate range given for the generation of slides being used.
Generation-specific ranges are attributed to differences between freeze-dried materials and fresh specimens. They do not
indicate a change in the accuracy of patient results.
Each range has been determined on a number of VITROS DT Chemistry Systems in a single laboratory. If your results do
not fall within the published range specified on the assay sheet, you should investigate reconstitution error (e.g., pipetting
wrong volume of diluent, or loss of freeze-dried material during reconstitution).
Additional performance information can be found on the appropriate Instructions for Use sheet.
•
•
•
References
1.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date
(Year-Month-Day)
Tests
Keep Dry
Lot Number
Device
This end up
SN
Serial Number
Store At or Below
Irritant
REF
Catalog Number or
Product Code
Store At or Above
Attention: See
Store Between
Manufacturer
ml
Version 2.0
Pub. No. J23111 EN
a
procedures
Revision History
DT Controls
Revision History
Date of
Revision
2004-02-29
Version
2.0
2003-05-30
1.0(905662h)
New format, technically equivalent to 905662h with the following minor
changes:
• Updated Glossary of Symbols
• Updated list of enzymes added to the human serum base pool and their
sources
• Clarified product use and assay acceptability
• Reworded Precautions to match the carton
• Added Note to Reconstitution and Test Procedure
Signature
Obsolete Date
C€
EC I REP
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
Pub. No. J23111_EN
Version 2.0
j P roducts
VITR[fl5
Chemistry!
DT isoenzyme control
Intended Use
VITROS DT Isoenzyme Control is designed for use in monitoring the performance of VITROS DT Chemistry Systems.
Reagents
VITROS DT Isoenzyme Control is prepared from bovine serum albumin to which human CKMM from skeletal muscle, human
CKMB from heart tissue, inorganic salts, stabilizers, and preservatives have been added. VITROS DT Isoenzyme Control
Diluent is prepared from processed water. This product is specially formulated for use on VITROS DT Chemistry Systems.
prepared from bovine serum albumin to which human tissue extracts have been
added. The tissue donors used in preparation of the product have been tested
and found to be nonreactive for hepatitis B surface antigen (HBsAg), antibody to
HCV, and antibody to HIV using FDA approved methods. However, since no test
can offer complete assurance that infectious agents are absent, this product
should be handled following the recommendations in NCCLS Guideline NI29V or
other published biohazard safety guidelines. This product should be handled
using the same precautions as with any other blood or blood-derived product.
Wear impervious gloves and proper protective clothing. Safety glasses are recommended. Good ventilation in the work area is
recommended. Minimize the potential for production of aerosols.
First Aid
medical attention if skin is cut or punctured. Eye - Immediately flush eyes with plenty of water for at least 15 minutes and get
Transportation
Version 2.0
Pub. No. J23113 EN
Reconstitution
Reconstitution
NOTE;
Each bottle of control has a corresponding diluent labeled by number. Use the
appropriate diluent in the reconstitution of the lyophilate.
1. Materials should be at room temperature before reconstitution. Vials should sit out approximately 60 minutes at room
temperature when taken from freezer storage.
5. Add exactly 3.0 ml_ of the appropriate diluent to each vial. Use a clean, dry pipette for each vial. A Class A volumetric
pipette, or an automated pipette of equivalent accuracy, is recommended because of the importance of this reconstitution
procedure to the accuracy of the results. Discard any remaining diluent.
7. Keep all control fluids tightly stoppered when not in use. At the time of reconstitution, it is recommended that the operator
date and initial the vial.
stability.
Storage
Storage and Stability for DT Isoenzyme Control
Storage Condition
Unopened
Frozen
<-18°C(<0°F)
Reconstituted
Refrigerated
2°-8°C (36°-46°F)
Refer to the Assay Sheet for analyte-specific stability information.
Exposure to light must be minimized to preserve creatine kinase activity.
Stability
Materials Provided
12 vials of lyophilized control.
12 vials of diluent containing 5 ml_ each.
Test Procedure
After reconstitution, the control serum should be assayed in the same manner as a patient sample. The reported values can
then be compared with those given on the assay sheet.
NOTE:
1.
2.
3.
4.
5.
6.
7.
8.
Mix vial thoroughly by gently inverting several times. DO NOT SHAKE.
Discard reconstituted control after 5 days.
Assay Values
•
•
Obtained values should fall within the published values for the lot number in use. Be sure the lot number on the assay
sheet is the same as the lot number printed on the label of the vial being used.
If separate generation-specific assay ranges are listed, use the appropriate range given for the generation of slides being
used. Generation-specific assay ranges are attributed to differences between freeze-dried materials and fresh specimens.
They do not indicate a change in the accuracy of patient results.
Pub. No. J23113 EN
Version 2.0
[•I ViTRI
References
•
Each range has been determined on a number of VITROS DT Chemistry Systems in a single laboratory. If your results do
not fall within the published ranges specified on the assay sheet, you should investigate reconstitution error (e.g., pipetting
wrong volume of diluent, or loss of freeze-dried material during reconstitution).
Additional performance information can be found in the appropriate Instructions for Use sheet in the Operator's Manual.
•
References
1.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Date
(Year-Month-Day)
Tests
Keep Dry
Lot Number
Device
Serial Number
Catalog Number or
Product Code
Attention: See
Manufacturer
t
.1
X
It
This end up
Store At or Below
Irritant
Store At or Above
procedures
Store Between
Revision History
Date of
Revision
2004-02-29
Version
2.0
2003-03-21
1.0 (905601 h)
New format, technically equivalent to 905601 h with the following minor
changes:
• Clarified product use and assay value acceptability
• Reworded Precautions to match carton
• Added Note to Reconstitution and Test Procedure
• Added Glossary of symbols, Revision History, signature block, CE mark,
Signature
Version 2.0
Obsolete Date
Pub. No. J23113 EN
Revision History
C€
EC
I REP
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
m, company
Pub. No. J23113 EN
Version 2.0
I Products
viTRms
Chemistry I
DT Reference Fluid
Intended Use
VITROS DT Reference Fluid is used in the potentiometric measurement of sodium (Na+), potassium (K*), chloride (Cl~), and
carbon dioxide (CO2) on VITROS DT Chemistry Systems.
Reagents
VITROS DT Reference Fluid is an aqueous solution of electrolytes and a polymer agent. An inert green dye has been added
for better visibility in the pipette tip.
4.5 mM potassium chloride, 9.0 mM sodium acetate, 25.0 mM sodium bicarbonate, 0.05 mM sodium bromide and 103.5 mM
sodium chloride.
Other Ingredients
Dye, polyvinylpyrrolidone, preservative, and sodium hydroxide.
This product is low hazard for usual handling.
Flush to sewer with large amounts of water.
First Aid
Inhalation - Remove to fresh air. Seek medical advice. Skin - Wash skin after each contact with soap and plenty of water for at
least 15 minutes. If symptoms are present'after washing, seek medical advice. Eye - Immediately flush eyes, including under
the eyelids, with plenty of water for at least 15 minutes. Seek medical advice. Ingestion -Seek medical advice, if needed.
Transportation
Storage
IMPORTANT;
Do Not Freeze.
Fluid Storage and Stability for DT Reference Fluid
Reference Fluid
Unopened
Opened
Version 2.0
Storage Condition
Refrigerated
2°-8°C (36°-46°F)
Room temperature
18°-28 °C (64°-82°F)
Refrigerated
2°-8°C (36°-46°F)
Pub. No. J23114 EN
Stability
<8 hours
<1 month if tightly stoppered
INSTRUCf IONS FOR USE
DT Reference Fluid
Materials Provided
Materials Provided
4 bottles of VITROS DT Reference Fluid containing 10 mL each.
Laboratory wipes.
Test Procedure
The fluid must be allowed to reach room temperature before use. A minimum period of 15 minutes is recommended for
refrigerated fluid.
1. Gently invert bottle of VITROS DT Reference Fluid several times in order to mix the fluid. DO NOT SHAKE.
2. Remove the cap and squeeze at least 4 drops into the small well of the dual-sample cup placed in the sample holder on the
analyzer.
3. Before recapping the bottle, gently wipe off any residual reference fluid from the tip with laboratory wipes.
4. At the time of initial use, it is recommended the operator date and initial the bottle.
5. Refer to the Operator's Manual for additional instructions on sample analysis.
6. Discard any unused portion in the dual-sample cup after analysis.
7. Return the bottle of VITROS DT Reference Fluid to refrigerator storage.
8. Discard any unused portion in the bottle after 1 month.
Glossary of Symbols
The Glossary of Symbols table defines the symbols used on the VITROS DT Chemistry Products packaging and on the
VITROS DT Chemistry Products Assay Sheets.
Glossary of Symbols
Ne pas reutiliser
Representant autorise dans
I'Union europeenne
A utiliser avant la date
de peremption
(Annee-mois-jour)
Suffisant pour "n" dosages
Pour diagnostic in vitro
Nutnero de lot
Numero de serie
I
Conserver a une temperature
inferieure ou egale a
Reference catalogue
ou code produit
X
superieure ou egale a
Attention: Consulter le
mode d'emploi.
X
comprise entre
Fabricant
I
Attention, fragile.
Tenir au sec
i
Haut
Irritant
t)
Le fabricant suit des
procedures de gestion de
I'emballage
Consultez la notice d'utilisation
Pub. No. J23114 EN
Version 2.0
(3 VITR^S
Revision History
DT Reference Fluid
Revision History
Date of
Revision
2004-02-29
Version
2.0
New format, technically equivalent to 906089k with the following minor
changes:
2003-03-28
1.0
•
•
•
•
•
•
Reworded Intended Use.
Added Reagents section.
Reworded title to Test Procedure.
Added mixing instructions to Test Procedures.
Added introductory sentences to the Test Procedure.
Added Glossary of Symbols, Revision History, signature block, CE mark,
Obsolete Date
Signature
Version 2.0
Pub. No. J23114 EN
Revision History
DT Reference Fluid
C€
I EC
REP I
Johnson & Johnson
High Wycombe
Buckinghamshire
HP12 4DP
United Kingdom
company
Pub. No. J23114 EN
Version 2.0
Chemistry
7% BSA
Intended Use
VITROS 7% BSA is used to dilute samples when assay values exceed the reportable (dynamic) range.
Reagents
VITROS 7% BSA is an aqueous solution of bovine serum, inorganic salts, and preservatives.
I
None
Other Ingredients
7% bovine serum albumin, inorganic salts and preservatives
Precautions
While these products are bovine in origin, they should be handled using the same precautions as with any other blood or bloodderived product.
with a 5.25% sodium hypochlorite solution (household bleach) diluted with 9 parts water and leave undisturbed for at least
30 minutes. Excess or unwanted materials and packaging for this product should be disposed of with other clinical waste.
First Aid
•
•
•
•
Skin - W a s h skin after each contact with soap and plenty of water. If symptoms are present after washing, seek medical
advice.
Eye - Immediately flush eyes, including under the eyelids, with plenty of water for at least 15 minutes. Seek medical advice.
Ingestion - Drink 1-2 glasses of water. Seek medical advice.
Transportation
Version 2.0
Pub. No. J11460
N/ITFJCpEB 0
7% BSA
Storage
Storage
Fluid Storage and Stability for 7% BSA
7% BSA
Frozen
Refrigerated
Refrigerated
On-analyzer*
Unopened
Opened
*
Storage Condition
<-18°C (<0°F)
2°-8°C (36°-46°F)
2°-8°C (36°-46°F)
Stability
<7 days
VITROS 250 System only.
For additional information and instructions, refer to the operator's manual for your VITROS Chemistry System.
Materials Provided
•
12 vials (5 ml_ each) of VITROS 7% BSA (CAT No. 826 2487)
•
An accurate pipette for performing dilutions
Test Procedure
1.
2.
3.
4.
5.
6.
7.
Warm fluid to room temperature, 18°-28°C (64°-82°F), prior to use (approximately 30 minutes when taken from the "
refrigerator, 60 minutes from the freezer).
Mix thoroughly by gentle inversion. DO NOT SHAKE.
After thorough mixing, remove the seal and stopper from each bottle just prior to use. Keep all fluids tightly stoppered when
not in use. At the time of initial use, it is recommended the operator date and initial the bottle.
Refer to the Instructions for Use for the appropriate VITROS slides for dilution directions.
Analyze the specimen as instructed in the VITROS Operator's Manual.
Store the tightly stoppered bottle of VITROS 7% BSA in the refrigerator.
Glossary of Symbols
Glossary of Symbols
Do Not Reuse
Manufacturer
Date (YYYY-MM-DD)
Lot Number
Tests
SN
Number
Q——
KCI-
Catalog Number or
Product Code
Attention: See
f
t
Store At or Below
X
I
Store Between
Use
Care.
Keep Dry
i
This end up
Store At or Above
Pub. No. J11460
Version 2.0
Revision History
7% BSA
Revision History
Date of Revision
2003-07-28
Version
2.0
2002APR19
1.0- English only
•
•
•
Reactive Ingredients - removed 7% bovine serum albumin
Precautions - added the warning
New format, technically equivalent to 2000MAR27.
Signature
Version 2.0
Obsolete Date
Pub. No. J11460
Revision History
7% BSA
C€
I EC
REP I
Mandeville House
62 The Broadway
Amersham
England
ofctMm company
Pub. No. J11460
Version 2.0
company
September 19, 2005
IMPORTANT NOTIFICATION
New CDM PROM 0136 and Updated DT Control Assay Sheets for
VITROS® DT60/DT60II Chemistry Systems
Dear Customer,
This notification contains updated information for your VITROS® DT60/DT60II Chemistry
System including:
Calibration Data Module (CDM PROM) 0136
CDM 0136 contains data that allows you to use new lot numbers of VITROS® DT Slides and
VITROS DT Calibrator Kits.
Install this CDM in your VITROS DT60 or DT60 H System at your earliest
convenience. You will not lose calibration for any tests that are currently
calibrated and are within expiration dates. Be sure to power off your analyzer
before you install the CDM. Refer to Section 2.3.3 of your operator's manual for
complete instructions for installing the CDM.
Updated Control Assay Sheets
The enclosed control assay sheets, revised 2005-08-22, contain ranges for all current generations
of VITROS DT Slides supported on CDM 0136. Revisions to the control ranges are always
flagged with a change bar (|). The control ranges for VITROS Chemistry Products CK DT
Slides have been updated for the following:
.
VITROS CK DT GEN 60 and GEN 61:
o LOT V5856
o LOT W5858
Select the assay sheets for the lot numbers of controls you are using or have in stock.
Replace any previous versions of control assay sheets with a revised sheet. Be sure to
replace the sheets packed inside any control boxes. Use these updated control ranges for
any tests you run.
Ref. CD05-135_xUSFH
Page 1 of 1
company
We thank you for your continued use of VITROS DT Chemistry Systems. If you have any
questions, please do not hesitate to call our Hotline Support Center.
Please distribute this info to all relevant persons. We only have sent this to your attention.
Sincerely,
Annemie Dries
' J1'
Jj)
Customer and Commercial
Services Manager
Ref. CD05-135_xUS_V2_draft
Page 1 of 1
I Products
VITRCpS1 Assay Summary
1 12
Chemistry I
igMTROS DTCalibratorsSS
M.. :.:B6tila|fe!SE';beoriweritipnat ÎMfift
Ml I)'
t
| Bilirubin, Neonatal
NBILDT
TBD-DT
Serum or Heparin plasma
'«"
. Bilirubin, Total
!
«*
! Cholesterol
1.2 3, & 4
1 - 500 umol/L
1 - 500 umol/L
DT Calibrator Kit
1,2,&3
5 - 900 L7L
5-900U/L
j DT Calibrator Kit
1,2, & 3
0.1-20 mg/dL
2-342umol/L
1,2, & 3
0 I 20 mg/dl.
2 -342 umol/L
DT Calibrator Kit
Isotonic saline or reagent grade water
9-30 t imol-'L
9 - 30 umol L
Refer to AMYL DT TFU* Patient sera with
low amyiase activiiy or Tsotonic saline
30-HOL7L.
J0-I10U/L
1.0-10.5 mg/dL
17-180nmol/L
|VITROS7%BSA
V1TROS 7% BSA or reagent-grade water
0 2 - 1 3mg,dL
3 - 2 2 umol'L
Desirable < 200 mg<'dL
Border line 200 - 239 ma'dl
High >240 mg/dL "
' ^ 2 mmol 'L
5 2 - 6 2 mmol L
>6 2 mmol I
Low <40 mgldL
High S60 mg/dL
<1 Ommol/L
>1.6mmol;L
M 0 8 - 1 5mg,dL
F 0 7 - 1 2 ,ng/JL
7 1 - 13>(imoli
62 -10C-union
! DT Calibrator Kit
1, 2, & 3
50 - 325 mg/dL
HDLCDT
! DT Calibrator Kit
{Do not pre-treat
^calibrators)
1, 2, & 4
1-llOrmj'dL
0.03-
CRBA DT
Serum, HDI'A plasma, Heparin plasma
(except Ammonia Hep?.i in)
DT Calibiatoi Kit
1.2,1, &4
OOl-lSmg'dl
1
Glucose
GLUDT
Scrum, Heparin/iiDTA plasma, Sodium
' Fluoride/Potassium Oxalate, plasma
DT Calibrator Kit
I.2.&.!
20- 450 mg/dL
l.l-25mmoI.'L
Isotonic saline or reagent-grade watv'r
Fasting Adults 74-I06mg,'dL
4 1-5 Qmrnol/L
Lactate
LAC DT
Fluoride (Xaldte plasma Ileparsn plasma*
DTCaliljiatorKit
1,2, &.;
0 5 12 mmol I.
0 5~12 0mmol-L
Isotonic saline or leagent-grade water
0 7 - 2 1 mmol L
0""-2 1 mmol.'l.
MgDT
DT Calibrator Kit
I.2.&3
0 2 - 7 0 mg/dL
0 1 - 2 9 mmof/L
Isotonic salme or reagent-giadc water
1 0 - 2 3 mg/'dL
0 7 10 mrtol/L
Phosphorous
PIIOSDT
DI Calibrator Kit
1.2, &4
0 5 - 1 3 0 mil dL
C 1 6 - 4 20mmoM.
2 S - 4 5 mg'dL
u S1 - 1 4> mmol.L
Total Protein
TPDT
Serum orllepdrin plasma
DT Calibrator Kit
1,2. & 3
2 0 - 1 1 0g/dL
2 0 0 - 1 1 0 0g/L
Creatinine
Magnesium
! Triglyceri.de
Urea Nitrogen
I Uric Acid
Carbon Dioxide
Chloride
TRIGDT | Serum, Heparin plasma*
BUN'
UREA DT
Sodium
Serum, Hepann plasma or EDTA plasma
URIC DT I Serum or Heparin plasma
CO; DT
Serum or Heparin . •
Serum, [leparin plasma*
Upper limits of temperature for refrigerate
jj' -
1, 2, & 3
15-400mg/dL
' DT Calibrator Kit
1.2.&3
1
I DT Calibrator Kit
1, 2, & 3
i
j
1
100 mg/dL
0.3-16 mg/dL
1.3-8.4mmol/L
2.84 mmol/L
1326nmol'l-
to - JwmmoL'L
i Isotonic salirfe or reagent-grade water
VITROS HDI,C Sample Diluent*
VITROS "% BSA or reagent-grade water
j 0.17-4.52mmol/L
I VITROS 7% BSA, Isotonic saline or
i reagent-grade water
0 4 - 3 5 7mmol/L
18-952 nmo!/L
-
I- •
ui i anbrator Kit
! Serum or Heparin plasma
MA^ DT
I. DT Calibrator Kit
I'
O DT Serum or Heparin piasma
Potassium
|"-"
DT Calibrator Kit
CHOL DT
HDL Cholesterol
fr i Micro HDL
Cholesterol KU_ __
I"
SIIM
M ! . asma (except Ammonia Heparin)
Serum or Heparin plasma (Samples from
patients other than newboms are not
recommended)
5"C
v
•
•IMVI ul
*:.
m
I- • J! •,
11 11
w - i4u mrnof/i-
Do not dilute
1&2
1,0 -11 mmol/L
1.0-11 mmol/L
f Do not dilute
DT Calibrator Kit
1&2
95 - 21S mrnol/L
95 - 215 mmol/L
Do not dilute
Upper limit of temperature fc: freeze
63 - 82 g/L
<1.69 mmol/L
1.69-2.25 mmol/L
2.26-5.64 mmol/L
__ >_5.65 mmol/L
T f - * 7 1 mmoi'L
2 5 - 6 J mmolCL
208 -506 umoi/L
149 - 369 Mmol/L
2 2 - 3 0 mmol 1
Donoi dilute
; DT Calibrator Kit
63-S2g/dI.
Normal: <150 mg/dL
Borderline high: 150-199 mg/dL
High: 200-499 mg/dL
Very High: >500 mg/dL
M: 9 - 2 0 mg/dL
f 7 - 1 7 mg/dL
M: 3.5-8.5 mg/dL
F: 2.5 - 6.2 mg/dL
NOTE: this chart applies to the VITROS DT60/DT60 II Chemistry Systems, VITROS DTE/DTE II modules, and VITROS
DTSC/DTSC II modules.
22 - 30 mmol 'L
98- 107 mmol/L
98- I07mmoI'I.
3 5 - 5 1 mmol/L - serum
Plasma range 0 1 - 0 7 mmol 'L
lower than serum range
3 5 - 5 1 minol'l. - seiiiin
'lasma :<tnge 0 i - 'J 7 mmol.L
lower than serum ranee
137- 145minol.t.
137- 145 mmol/L
* IFJ - Instructions For Use. For details on IFU, refer to www.orthoclinical.com
This information was current as of the publication date. The Instructions For Use are the authorized source for information about VITROS assays.
©Ortho-Clinical Diagnostics, Inc., 2005 • VITROS is a trademark of Ortho-Clinical Diagnostics, Inc. • 100 Indigo Creek Drive • Rochester, NY 14626-5101
Pub.
No. J234Q7 EN
2005-08-12
?
Ortho-Clinicai Diagnostics
a (joJm*cn-<|}efttt*OK company
Products
VITR
Assay Summary
Chemistry
2/2
Recommended Diluent*
BpttteNosset Cojwentional Unit*5
Aianine
j Aminotransferase
MM 111
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1
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1 2 i. ••
1 " - : . . . . i I.
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t
r
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1 _.*.,
|IH( K | i
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l
-_id."-J[
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'
- I"
•• - I
i
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• ,ivw.m-.. . i n .
.|-\ iI
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hs\
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no 1
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1 .ir-: ...
vi.,"
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[in
•
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IJI S.-U.I.•llv
i ~ - . i i i'<*-.:- j
13 -69 U/L
21 -72 U/L
9 -52 U/L
.
!
dl I L .1 IL^J.11. J".'..l ' * , it
•
• 'KMHDI
4 ~
i
.... . - , „ . -
Adult 13-69 U/L
M. 21-72 U/L
F:9-52U/L
: VITROS 7% BSA or Isotonic saline
I
Ml!
i
iP.
i
3 - 950 U/L
i DT Calibrator Kit
N
Ii l H
C I ; . ' 11. .liM*"*
i
•
Serum, Hepann, or EDTA piasma
•\M 1)1
I ' l l
{••
(
ALTDT
^::
!K~'»iii.!
y
i
inioll
^,je—.i
, "P.-o.. i-TTE'I
:i.^ i
•», j s s a - d . l T P - o
DTSC/DTSC II modules.
j This information was current as of the publication date. The Instructions For Use are the authorized source for information about VITROS assays.
©Ortho-Clinical Diagnostics, Inc., 2005 • VITROS is a trademark of Ortho-Clinical Diagnostics, Inc. • 100 Indigo Creek Drive • Rochester, NY 14626-5101
Pub. No. J23407 EN
2005-08-12
''Ortho-Clinical Diagnostics
VITROS DT Isoenzyme Control I
814 6003
Assay Sheet for VITROS DT and DT II Systems • Fiche de controle pour les Systemes VITROS DT et
DT II • Datenblatt fur VITROS DT und DT II Systeme • Hoja de ensayo para los Sistemas VITROS DT
y DT II • Folha do Ensaio para os Sistemas VITROS DT e DT II • Foglietto di dosaggio per Sistemi
VITROS DT e DT II • Kontrolark til VITROS DT og DT II Systems • Kontrollblad for VITROS DT och
DT II • <t>uAAo avaAuCTEOJv via Ta auaTrjuaTa VITROS DT KCU DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
CONV
N5555
2005-10-31
2005-08-22
SI
2005-03-14
GEN
60
61
71
72
73
74
CK
CKMB
163
142
20
19
22
16
133-193
112-172
U/L
163
142
15-25
14-24
17-27
11 -21
U/L
20
19
22
16
133-193
112-172
15-25
14-24
17-27
11-21
English
Reconstituted Stability
When stored at 2-8°C (36-46-F):
• Stable for 5 days.
• 3 Important
Minimize room temperature exposure of freeze-dried control or reconstituted control fluid.
Francais
Stabilite Reconstitue
Conservation a 2-S°C (36-46°F):
• Stable pendant 5 jours.
CH Important
Limiter 1'exposition a la temperature ambiante de I'echantillon de contrfile lyophilise ou du liquide de contrflle reconstitue.
Deutsch
Stabilitat nach der Rekonstitution
Bei Lagerung zwischen 2 und 8 °C:
• Stabil fur 5 Tage.
U/L
U/L
I CONV I Conventional • Unites
'
' Ponderales • KonvenBonelle
Einheiten • Convencional •
Convencional • Convenzionale •
Konventionel • Konventionella
enheter • EUU(3CITIK£C; • Konvansiyonel
|—oj—I
1
s l Unites s l
*
• Sl-Einheiten •
' SI • SI • SI • SI • Sl-enheter •
Movdoc; SI • SI
t
value • Resultat • V\fert •
» » > ¥ * i Valor-Valor-valoreVserdi • Varde • T\\if\ • Dejjer
,,
„ Range. The analyzer value
should fall within this range.
• Tolerance. La valeur de I'analyseur
doit se trouver dans cet Intervalle. •
Messbereich. Der mit dem
AnalysegerSt erhaltene W a t sollte sich
innerhalb dieses Bereichs bewegen. •
Intervalo. El valor del anaiizador debe
estardentro del rango. • Intervalo. O
valor do analisador devera estar dentro
deste intervalo. • Intervallo. II valore
ottenuto sull'analizzatore dovrebbe
rientrare in questo intervallo. • Omrade.
Analyseinstrumentets vasrdi skal iigge
inden for dette omrade. • Intervall.
Analysinstrumentets varde bor ligga
inom detta omrade. • EOpoc TIUOOV.
H Tiurj TOU avaAuTii Trpeirei va eunlnrci
a t OUT6 TO zupoq TIJJUW. • Aralik.
03 Wichtig
Analizorun degeri bu aralikta olmalidir.
Gefriergetrocknete Kontrolle oder rekonstituierte Kontrollflussigkeit moglichst kurz der Raumtemperatur aussetzen.
Espafiol
Estabilidad d e la Reconstitucion
Cuando se conserva a 2-8°C (36-46°F):
• Estable durante 5 d(as.
Q3 Importante
Reducir al mlnimo la exposicion a temperaturas ambiente del control liofilizado o del llquido de control reconstituido.
PortuguSs
Estabilidade apos Reconstituicao
Quando conservado a uma temperatura entre 2 e 8°C:
• Estavel durante 5 dias.
• 3 IMPORTANTE
Minimizar a exposicSo do Itquido de controlo liofilizado ou reconstituido a temperatura ambiente.
Italiano
Stabilita Dopo La Ricostituzione
Conservato a 2-8°C (36-46°F):
• Stabile per 5 giorni.
jrv»_ Revised-Mise a jour d u M l Revidiert • Revisifin •
I f f l Revisto a • Aggiornato al •
Revideret • Reviderad • Ava8tupi<i8r)K£
• Revize edildi
^ ^ 4 _
Supersedes • Remplace la
I ^ B ^ f f l l v e r s ' o n d u ' Ersetzt •
l ^ a f f l J Substituye• Segue-sea•
Sostituisce la versione del • Erstatter •
Ersatter • YTrtpioxuei • Yerine gecer
AIIU/mLandU/Lat37°C. • Les
activites enzymatiques sont
determinees a 37°C. • Enzymaktivitaten
werden bei 37 °C gemessen. • Todos
los valores de U/mL y U/L nan sido
calculados a 37°C. • Todas U/mL e
U/L a 37°C. • I valori U/ml e U/L sono
determinati a 37°C. • Alle U/ml og
U/l ved 37° C. • Alia U/mL och U/L
vid 37°C. • O A E ; OI U/mL KOI U/L
OTOU? 37°C. • 37 °C'de turn U/mL
ve U/L.
Q3 Importante
Limitare al minimo I'esposizione a temperatura ambiente del controllo. liofilizzato o del fluido di controllo ricostituito.
Dansk
Rekonstitutionsstabilitet
Ved opbevaring ved 2-8° C:
• Stabil i 5 dage.
• 3 Vigtigt
S0rg for, at frysetgrret kontrol eller rekonstitueret kontrolvasske kun eksponeres minimalt for stuetemperatur,
f Ortho-ainkal Diagrostics
VITROS is a trademark of Ortho-Clinical Diagnostics, Inc. www.orthoclinical.com
1(2)
V1TR0S DT Isoenzyme Control I
DT II • <J>uAAo avaAuaEwv yia ra auaTrjuaia VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
Svenska
Stabilitet efter rekonstitution
REF
814 6003
N5555
2005-10-31
2005-08-22
2005-03-14
Forvaring vid 2-8°C (36-46T):
• Stabil i 5 dagar.
• 3 Viktigt!
Minimera exponering av frystorkad tontroll eller rekonstituerad kontrollvatska for rumstemperatur.
Diav crrroenKEOtiai at etpuoKpaofa 2-8°C (36-46°F):
Iia6ep6 yia 5
CB
x
irjv htBiar\ at tepuoKpaakx Suuailou IOU uypoO tAfyxou, TTOU tyti UTroaitl ^ p a v o n uioio y<J£,q<; f\ TTOU ^X £I
avaauora&l.
Sulandinlmi§ Halde Stabilite
2-8 "C'de saklandigjinda:
• 5 gun stabildir.
B Onemli
Lliyofilize kontrolOn veya sulandinlmis kontrol sivisinin oda sicakliQina maruziyetini en aza indirin.
^ O r t t o - g n j c a l Diagnostics
2(2)
REF
DT II • cpuAAo avaAuuEWV yia TO auorriuciTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
CONV
SI
LOT
814 6003
P5854
2006-10-31
2005-08-22
2005-03-14
GEN
CK
60
61
132
130
CKMB
71
15
15
19
11
72
73
74
102-162
100-160
10-20
10-20
14-24
6-16
U/L
U/L
132
130
15
15
19
11
102-162
100-160
U/L
10-20
10-20
14-24
6-16
U/L
English
When stored at 2-8°C (36-46°F):
0 3 Important
Minimize room temperature exposure of freeze-dried control or reconstituted control fluid.
Francais
Conservation a 2-8°C (36-46°F):
LTD Important
LImiter rexposition a la temperature ambiante de I'echantillon de controle lyophilise ou du liquide de controle reconstitue.
Deutsch
• Stabil for 5 Tage.
• 3 Wichtig
Gefriergetrocknete Kontrolle Oder rekonstituierte Kontrollflussigkeit moglichst kurz der Raumtemperatur aussetzen.
Espaftoi
Estabilidad de la Reconstitucion
• Estable durante 5 dlas.
03 Importante
Reducir al mlnimo la exposicion a temperaturas ambiente del control liofilizado o del Ifquido de control reconstituido.
Portugues
03 IMPORTANTE
Minimizara exposicao do llquido de controlo liofilizado ou reconstitutdo a temperatura ambiente.
Italia no
'
I C O N V I Conventional • Unites
' Ponderales • Konventionelle
Einheiten • Conventional •
Conventional • Convenzionale •
enheter • ZuppaTiKt; • Konvansiyonel
SI-Unites SI-Sl-Einheiten •
SI-SI-SI-SI-SI-enheter>
Movdoe? SI • SI
'i
Value • Resultat • Wfert •
**am
valor-Valor-Valore •
Vasrdi-Varde-Tiurj-Deger
I,
w Range. The analyzer value
doit se trouver dans cet intervalle. Messbereich. Der mit dem
Analysegerat erhaltene Wfert sollte sich
Intervalo. El valor del analizador debe
estar dentro del rango. • Intervalo. O
Analyseinstrumentets vaerdi skal ligge
inom detta omrade. • Eupo? Tipciiv.
H Tiun, TOU avaAuTii TrpeTrei va cuTrnrnei
at OUT6 TO tupa; Tiutuv. • Aralik.
ft.
Revised • Mise a jour du •
Wm Revidiert • Revisi6n •
i ^ J Revisto a • Aggiomato al •
Revideret • Reviderad • Ava6E(opr}6r|KE
• Revize edildl
n g f c f t v Supersedes • Remplace la
H K E S ] version du • Ersetzt •
i S r f f l l Substituye-Segue-seaSostituisce la versione del • Erstatter •
Ersatter • YirrepioxuEi • Yerine geger
All U/mL and U/L at 37°C. • Les
U/L a 37-C. • I valori U/ml e U/L sono
U/I ved 37° C. • Alia U/mL och U/L
vid 37"C. • OAEC OI U/mL Kdi U/L
orou? 37"C. • 37 °C'de turn U/mL
ve U/L.
03 Importante
Dansk
03 Vigtigt
S0rg for, at fryseterret kontrol eller rekonstitueret kontrolvasske kun eksponeres minimalt for stuetemperatur.
ÔrfogQinical Diagnost'cs
1(2)
y DT II • Foiha do Ensaio para os Sjstemas VITROS DT e DT II • Foglietto di dosaggio per Sistemi
DT II • <t>uAAo avaAOaewv via m auaTnuaTa VITROS DT KQ\ DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
Svenska
FOrvaring vid 2-B°C (36-46T):
814 6003
LOT
P5854
2006-10-31
2005-08-22
2005-03-14
03 Viktigt!
Minimera exponering av frystorkad kontroll eller rekonstituerad kontrollvatska Tor rumstemperatur.
EAAn,viK<S
Diav OTT09r|K£i5eTai at 6epuoKpaola 2-8°C (36-46°F):
£ia6Ep6 yia 5 riu£p«;.
CB
EAaxioiOTroiriaiE iqv tK6tar\ at eepuoKpaofa Siouarfou IOU uypoO tAiyxou, TTOU £X« UTrooicf ^pavor) piaw i(iO5n? f\ TTOU t%a
avaouoiaetl.
S u l a n d i r i l m i ; H a l d e Stabilite
2-8 °C'de saklandiginda:
• 5 gOn stabildir.
QD Onemli
Lliyofflize kontrolon veya sulandinlmis kontrol sivismin oda sicakhQina maruziyetini en aza indirin.
t
prtho-ClJnical
2(2)
VITROS DT Control I
REF
DT II • Datenblatt fiir VITROS DT und DT II Systeme • Hoja de ensayo para los Sistemas VITROS DT
y DT II • Foiha do Ensaio para os Sistemas VITROS DT e DT II • Foglietto di dosaggio per Sistemi
DT II • OuAAo avaAuatcov yia Ta auaTqijaTa VITROS DT KOI DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
SI
CONV
LOT
842 0317
Q5480
2005-09-30
2005-08-22
2005-03-14
GEN
ALB
54
55
2.4
2.2
2.1-2.7
1.9-2.5
g/dL
24
22
ALKP
ALT
55
90
76-104
U/L
90
26-50
22-46
24-48
23-47
U/L
57
58
59
38
34
36
35
89
38
34
36
35
64-114
21 -59
U/L
U/L
89
40
mg/dL
mg/dL
6.4
AMYL
75
AST
58
54
40
Ca
69
70
71
72
73
9.0
9.2
9.3
9.0
9.2
CHE
51
53
57
58
59
60
61
3.62
3.42
146
150
152
146
164
ClCO2
53
81
52
23.7
CREA
CRSC
51
1.1
54
57
56
57
55
57
53
54
55
56
1.1
1.1
84
82
15-21
8.4 - 9.6
8.6 - 9.8
8.7 - 9.9
8.4 - 9.6
8.6 - 9.8
3.02 - 4.22
2.82 - 4.02
133-159
137-163
139-165
114-178
132-196
76-86
18.7-28.7
0.8-1.4
0.9-1.3
0.9-1.3
68 - 100
66-98
71
75
59-83
63-87
U/L
70-92
71 -93
71 -93
78-100
mg/dL
55
56
57
81
82
82
89
33
32
34
22-44
21 -43
23-45
mg/dL
K+
51
2.8
LAC
59
60
61
59
60
52
53
57
58
1.4
1.4
1.4
441
435
1.0
1.2
200
188
2.5-3.1
1.1-1.7
1.1-1.7
1.1-1.7
393 - 489
387 - 483
0.6-1.4
0.8-1.6
182-218
170-206
mmol/L
mmol/L
UN/UREA
CHOL
CK
Fe
GT
GLU
HDLC
LDH
Li
LIPA
18
U/mL
mg/dL
2.25
2.30
2.32
2.25
2.30
3620
3420
3.8
3.9
3.9
U/L
146
164
mmol/L
mmol/L
mg/dL
mg/dL
81
23.7
U/L
mmol/L
U/L
21 •27
19 • 2 5
76-104
26- 50
22- 46
24- 48
23- 47
64-114
21 -59
5.4 - 7.5
2.10- 2.40
2.15- 2.45
2.17- 2.47
2.10- 2.40
2.15- 2.45
3020- 4220
2820- 4020
3.4- 4.1
3.5- 4.2
3.6- 4.3
114- 178
132- 196
76-86
97
18.7-28.7
71 -124
97
97
15.0
14.7
80- 115
80- 115
12.2- 17.9
11.8 • 17.5
71
75
4.5
4.6
4.6
4.9
59- 83
63- 87
3.9- 5.1
3.9- 5.2
3:9- 5.2
4.3- 5.6
0.57- 1.14
0.54- 1.11
0.59- 1.16
0.85
0.83
0.88
2.8
1.4
1.4
1.4
441
435
1.0
1.2
200
188
2.5-3.1
1.1 1.7
1.1 1.7
1.1 1.7
393- 489
387- 483
0.6 • 1 . 4
0.8
U/L
U/L
Conventional • Unites
Ponderales • Konventionelle
enheter • luupcrriKfc; • Konvansiyonel
SI • Unites SI • Sl-Einheiten •
SI • SI • SI • SI • Sl-enheter •
Movd6£?SI-SI
U/L
U/L
mmol/L
mmol/L
U/L
mmol/L
U/L
mmol/L
mmol/L
pmol/L
(jmol/L
|Jmol/L
U/L
mmol/L
mmol/L
*
Value • Resultat • Wfert •
M-fr-—! valor -V&lor- Valore Vaerdi-Varde-Tiuii-Deger
I,
H Range. The analyzer value
doit se trouver dans cet intervalle. •
Anaiysegerat erhaltene Wert sollte sich
Analyseinstrumentets veerdi skai ligge
inom detta omrade. • EOpo? Tiutuv.
H Tiuri TOU avaAuni Trpnrei va EUTriTrra
a t auTO TO EOpo; TIUUV. • Arahk.
.?%-* Revised-Mise a jour d u *
Ifffflj Revidiert • Revisi6n •
ISSil Revisto a • Aggiomato al •
Revideret- Reviderad -AvaBEioprlSriKE
• Revize edildi
. A ^ Supersedes • Remplace la
H w M i | version du • Ersetzt •
\miim]
Substituye• Segue-sea•
Ersatter • YTTEPIOXUEI • Yerine ge?er
actlvites enzymatiques sont
werden bei 37 "C gemessen. • Todos
detemninati a 37"C. • Alle U/ml og
vid 37°C. • OAE? OI U/mL rai U/L
orou? 37°C. • 37 "C'de tilm U/mL
ve U/L.
mmol/L
mmol/L
U/L
mmol/L
•1.6
182- 218
170- 206
U/L
1(4)
VITROS DT Control 1
REF
Assay Sheet for VITROS DT and DT II Systems • Fiche de controle pour les Systemes VITROS DTet
DT II • OuAAo avaAua£U)v Yia Ta ouaTi]|jaTa VITROS DT KCJI DT 1I • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
LOT
842 0317
Q5480
2005-09-30
2005-08-22
CONV
GEN
Mg
58
59
Na+
NBIL
52
64
NH3
54
65
55
PHOS
58
59
"BIL
74
75
76
THEO
TP
62
62
63
64
TRIG
URIC
60
54
55
•As
«
—H
mg/dL
0.86
0.91
mmol/L
mg/dL
118
17
21
77
77
2.1
2.2
118
1.0
1.2
77
77
3.6
3.6
1.5
1.3
1.5
1.81.91130.30.5-
12.1
8.8- 15.4
3.1- 4.1
3.2- 4.2
3.5- 4.5
ug/mL
g/dL
9 3 - 123
3.6- 4.4
3.4- 4.2
mg/dL
mg/dL
3.6
3.7
4.0
108
4.0
3.8
2.4
2.5
123
1.7
1.9
4 2 - 112
4 2 - 112
3.0- 4.2
3.0- 4.2
1.0- 2.0
0.8- 1.8
1.0- 2.0
I
SI
umol/L
mg/dL
1.16
1.16
mg/dL
26
22
26
67
36
37
40
1.22
238
226
2005-03-14
—H
0.74 -0.99
0.78 -1.03
113 -123
594242-
29
32
112
112
0.97 -1.36
0.97 -1.36
mmol/L
mmol/L
pmol/L
|jmol/L
mmol/L
-34
-31
-34
-85
31 - 4 1
32 - 4 2
35 - 4 5
|jmol/L
1.05 -1.39
214 -262
202 -250
mmol/L
pmol/L
17
14
17
49
umol/L
g/L
English
Qg Pretreatment Required
. HDLC
• Stable for 3 days: ALKP, Ca, CK, NBIL, TBIL.
• Stable for up to 8 hours: NH3
Frangais
H[i] Pretraitement necessaire
, • HDLC
. Stable pendant 3 jours: ALKP, Ca, CK, NBIL, TBIL.
• Stable pendant 8 heures apres le pretraitement: NH3.
Deutsch
Qi] Vorbehandlung erforderlich
. HDLC
Stabil i tat nach der Rekonstitution
. Stabil fur 3 Tage: ALKP, Ca, CK, NBIL, TBIL.
• Bis zu 8 Stunden nach der Vorbehandlung stabil: NH3
Ôrtho-qinkal Diafflostics
2(4)
VITROS DT Control I
DT II • (MAAo avaAucr£U)v yia Ta auarrJijaTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
Espanol
[Jij Se requiere tratamiento previo
. HDLC
REF
LOT
842 0317
Q5480
2005-09-30
2005-08-22
2005-03-14
Cuando se consetva a 2-8°C (36-46°F):
• Estable durante 7 dfas.
• Estable durante 3 dfas: ALKP, Ca, CK, NBIL, TBIL
• Estable durante 8 horas despuSs de tratamiento previo: NH3.
Port ug ues
QiJ Necessario Tratamento Previo
• HDLC
Quando oonservado a uma temperature entre 2 e 8°C:
• Estavel durante 3 dias: ALKP, Ca, CK, NBIL, TBIL.
• Estavel durante 8 horas depois do tratamento previo: NH3.
Italiano
Qi] £ richiesto il pretrattamento
• HDLC
• Stabile per 3 giorni: ALKP, Ca, CK, NBIL, TBIL.
• Stabile per 8 ore dopo il pretrattamento: NH3.
Dansk
QV| Forbehandling pakraevet
. HDLC
• Stabil i 3 dage: ALKP, Ca, CK, NBIL, TBIL
• Stabil i 8 timer efter forbehandling: NH3.
Svenska
QT| Forbehandling kravs
• HDLC
Forvaring vid 2-8°C (36-46°F):
• Stabil i 7 dagar. • Stabil i 3 dagar: ALKP, Ca, CK, NBIL, TBIL.
• Stabil i 8 timmar efter forbehandling: NH3.
EAAr]ViKd
QT]
• HDLC
lTa9EpoTr|Ta avacruoraan,?
Drav arro9nKe0eiai at 6£puoKpaofa 2-8°C (36-46°F):
• Zia8£p6 yict 7 rptptc;.
Sia6£p6 y«a 3 HM^P^: ALKP, Ca, CK, NBIL, TBIL,
IiaSepo Yia 8 (ipec; ptra rnv TTpo£TT£|£pYaofa: NH3.
3(4)
VITROS DT Control I
DT II • Datenblatt filr VITROS DT und DT II Systeme • Hoja de ensayo para los Sistemas VITROS DT
y DT II • Foiha do Ensaio para os Sistemas VITROS DT e DT II * Foglietto di dosaggio per Sistemi
DT II • ct>uAAo avaAuaoov via TO auarrJuaTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
TUrkge
Qi] Gereken 6ni§lem
• HDLC
REF
842 0317
Q5480
2005-09-30
2005-08-22
2005-03-14
Sulandinlmi? Halde Stabilite
2-S "C'de saklandiijinda:
• 7 gtin stabildir.
• 3 gone kadar stabil: ALKP, Ca, CK, NBIL, TBIL
• 6n if lemden sonra 8 gQne kadar stabil: NH3.
4(4)
REF
DT II • <t>uAAo avaAucrewv yia Ta auaTrjuaTa VITROS DT KOI DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
LOT
Q6001
2007-03-31
2005-08-22
SI
CONV
814 6003
2005-04-19
GEN
CK
CKMB
132
102-162
127
97-157
15
10-20
16
11-21
10-20
15
10-20
7-17
12
7-17
60
132
102-162
61
127
97-157
71
15
10-20
72
16
11 -21
73
15
74
12
U/L
U/L
English
dS Important
Minimize room temperature exposure offreeze-driedcontrol or reconstituted control fluid.
Francais
Stabilite Reconstitute
OS Important
Limiter rexposition a la temperature ambiante de I'echantillon de controle lyophilise ou du liquide de contrOle reconstitufe
Deutsch
OB Wichtig
Gefriergetrocknete Kontrolle oder rekonstituierte Kontrollflussigkeit moglichst kurz der Raumtemperatur aussetzen.
Espaftol
• Estable durante 5 dfas.
Q3 Importante
Reducir al mtnimo la exposici6n a temperaturas ambiente del control liofilizado o del Hquido de control reconstituido.
Portuguis
Estabilidade apos Reconstituiâo
CB IMPORTANTE
Minimizar a exposigao do Hquido de controlo liofilizado ou reconstituido a temperatura ambiente.
Italiano
U/L
U/L
Ponderales • Konventionelle
Konventionel • Konvenfionella
enheter • luuftariKi; • Konvansiyonel
I—gj—I SI -Unites S I - Sl-Einheiten •
1
MovdOE? SI • SI
i
Value • Resultat • Wert •
mmmiiM valor • Valor • valore •
Vserdi-Varde-Tp^Deger
h
H Range. The analyzer value
Messbereich. Dermitdem
Analysegerat erhaltene Wert sollte sich
Intervalo. El valor del anatizador debe
deste intervalo. • Intetvallo. II valore
Analyseinstrumentets vaardi skal ligge
inom detta omrade. • EOpcx; Tiuiiw.
H Ti|jrj TOU avaAuiii npiirei va Eutriin£i
at auTo TO tCipo; TIUUV. • Aralik.
Analizfiriin degeri bu aralikta olmalidir.
Revidiert • Revision •
Revisto a • Aggiornato al •
Revideret • Reviderad • Ava8£(jopii8r|KE
• Revize edildi
t
^ i v
Supersedes • Remplace la
• M B ] version du • Ersetzt •
M H l f f l l Substituye • Segue-se a •
Ersatter • YTTEPIOXUEI • Yerine gecer
determinees a 37"C. • Enzymaktivitaen
los valores de U/mL y U/L han sido
U/l ved 37° C. -Alia U/mL och U/L
vid 37°C. • O A E ; OI U/mL KOI U/L
OTOU? 37"C. • 37 °C'de turn U/mL
ve U/L.
C0 Importante
Dansk
• 3 Vigtigt
Sarg for, at fryset0rret kontrol eller rekonstitueret kontrolvaaske kun eksponeres minirnalt for stuetemperatur.
1(2)
DT II • OuAAo avaAucjEuov via TCI ovcnf\\iana VITROS DT KCII DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
Svenska
• Stabll i 5 clagar.
REF
LOT
814 6003
Q6001
2007-03-31
2005-08-22
2005-04-19
OH Viktigt!
Minlmera exponering avfrystorkad kontroll eller rekonstituerad kontrollvatska for rumstemperatur.
EAAn.viKd
Oiav orrroeriKEOeiai os 6ep(jOKpaafa 2-8°C (36-46°F):
Iia6£p6 via 5 nu£p£?.
OS
oiE iny £K9EOT| oe etp^joKpaofa Swuailou IOU uypoO £A£YX°U, TTOU 4XEI UTTOOTEI ^pavon, |j£aco iÔ^n,? i^ TTOU txz\
avaauoia9El.
Sulandinlmi§ Halde Stabilite
5 gun stabildir.
Onemli
Lliyofilize kontrolQn veya sulandirilmi? kontrol sivisinin oda sicakhgina maruziyetini en aza indirin.
2(2)
VITROS DT Control I
REF
Assay Sheet for VITROS DT and DT I! Systems • Fiche de controle pour les Systemes VITROS DT et
DT II • OuAAo avaAuaewv yia m auorrjuaTo; VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
CONV
LOT[
842 0317
T5652
2006-04-30
2005-08-22
SI
2005-03-14
GEN
ALB
54
55
2.5
2.3
ALKP
55
88
ALT
56
57
58
59
60
75
76
26
33
31
31
32
108
112
AST
58
36
BUN/UREA
54
19
Ca
69
70
71
72
73
51
53
57
58
59
60
61
9.1
9.1
9.2
9.0
9.1
3.98
3.79
153
153
156
200
222
81
23.4
AMYL
CHE
CHOL
CK
ClCO2
CREA
CRSC
GGT
GLU
HDLC
K+
LAC
LDH
Li
53
52
1.3
51
54
57
56
57
55
57
58
53
54
55
56
55
56
_57
51
59
60
61
59
60
1.4
1.4
1.4
426
408
52
1.1
1.1
1.1
103
105
73
78
75
89
92
92
98
31
31
32
2.8
2.2-2.8
2.0-2.6
74-102
14-38
21-45
19-43
19-43
20-44
83-133
87-137
17-55
16-22
8.5 - 9.7
8.5 - 9.7
8.6-9.8
8.4 - 9.6
8.5-9.7
3.38-4.58
3.19-4.39
140-166
140-166
143-169
168-232
190-254
76-86
18.4-28.4
1.0-1.6
0.9-1.3
0.9-1.3
87-119
89-121
61 -85
66-90
63-87
78-100
81-103
81 - 103
87-109
20-42
20-42
21-43
2.5-3.1
1.1-1.7
1.1-1.7
1.1-1.7
378 - 474
360 - 456
0.7-1.5
g/dL
25
23
U/L
U/L
88
U/L
26
33
31
31
32
108
112
U/L
36
mg/dL
mg/dL
6.8
U/mL
mg/dL
U/L
mmol/L
mmol/L
mg/dL
mg/dL
U/L
mg/dL
mg/dL
mmol/L
mmol/L
U/L
mmol/L
2.27
2.27
2.30
2.25
2.27
3980
3790
4.0
4.0
4.0
200
222
81
23.4
115
97
97
18.4
18.8
73
78
75
4.9
5.1
5.1
5.4
0.80
0.80
0.83
2.8
1.4
1.4
1.4
426
408
1.1
22- 28
20- 26
74-102
14- 38
2 1 - 45
19- 43
19- 43
20- 44
83- 133
87- 137
17-55
5.7-7.9
2.12- 2.42
2.12- 2.42
2.15- 2.45
2.10- 2.40
2.12- 2.42
3380- 4580
3190- 4390
3.6- 4.3
3.6- 4.3
3.7- 4.4
168- 232
190- 254
76-86
18.4-28.4
88 - 141
80- 115
80- 115
15.6- 21.3
15.9- 21.7
61 • 8 5
66 • 9 0
63 -87
4.3- 5.6
4.5- 5.7
4.5- 5.7
4.8- 6.1
0.52- 1.09
0.52- 1.09
0.54- 1.11
2.5-3.1
1.1 1.7
1.1 1.7
1.1 1.7
378- 474
360- 456
0.7-1.5
g/L
U/L
U/L
enheter • luupariKfc • Konvansiyonel
SI -Unites S I - Sl-Einheiten •
SI • SI • SI • SI • Sl-enheter •
SI
J
Valor-Valor • ValoreVaardi • VaYde • Tun, • De§er
lgatBSM
U/L
U/L
mmol/L
mmol/L
U/L
mmol/L
U/L
mmol/L
mmol/L
|jmol/L
(jmol/L
Mmol/L
U/L
mmol/L
K
Range. The analyzer value
ri
Analyseinstnjmentets vsrdi skal llgge
inden for dette omra"de. • Intervall.
inom delta omrade. • EOpo? TIU&V.
H nun, TOU avaXuTrj TTPEWEI va EiJTrimEi
o t auTOTOEdpos HJJUIV. > Aralik.
Revidiert-Revisi6nRevisto a • Aggiornato al •
Revideret • Reviderad • Ava8£U)pti6r|K£
• Revize edildi
t
BBt£VM Supersedes • Remplace la
^ÊSffll version du • Ersetzt •
^ • r a f f i j Substituye-Segue-seaSostituisce la versione del • Erstatter •
Ersatter • YmpicrxuEi • Yerine gecer
Ail U/mL and U/L at 37°C. • Les
activites enzymatjques sont
U/l ved 37" C. • Alia U/mL och U/L
vid 37°C. - O A E ; 01 U/mL rai U/L
OTOUC 37°C. • 37 °C'de turn U/mL
ve U/L.
mmol/L
mmol/L
mmol/L
U/L
mmol/L
Ortho-Clinkal Pagnosties
1(4)
VITROS DT Control 1
842 0317
Assay Sheet for VITROS DT andDT II Systems • Fiche de controle pour les Systemes VITROS DTet
DT II • Datenblatl fur VITROS DT und DT II Systeme • Hoja de ensayo para los!Bistemas VITROS DT
VITROS DT e DT II • Kontrolark til VITROS tDT og DT II Systems • Kontrollblad for VITROS DT och
DT II • OuAAo avaAu0£U)v yia Ta ouoTiûaTa VITROS DT Kai DT 1
I • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
LOT
T5652
2006-04-30
2005-08-22
L CONV |
N
GEN
...Li
LIPA
53
57
58
59
Mg
58
59
Na+
NBIL
52
64
75
76
1.1
1.1
1.5
114
108
3.6
3.5
1.5
1.5
1.5
62
11.3
63
63
9.2
3.7
3.8
64
60
54
55
4.1
105
4.1
4.0
65
66
NH3
54
55
PHOS
58
59
TBIL
74
THEO
TP
62
TRIG
URIC
1.1
265
247
271
2.0
2.1
117
SI
H
M
0.7-1.5
247 - 283
229 - 265
253 - 289
1.7-2.3
1.8-2.4
112-122
0.4-1.8
0.4-1.8
0.8 - 2.2
79 - 149
73 - 143
3.0-4.2
2.9-4.1
1.0-2.0
1.0-2.0
1.0-2.0
8.0-14.6
5.9-12.5
3.2 - 4.2
3.3-4.3
3.6-4.6
90-120
3.7 - 4.5
3.6 - 4.4
mmol/L
U/L
1.1
265
247
271
mg/dL
0.82
0.86
mmol/L
mg/dL
117
umol/L
19
19
26
114
108
mg/dL
1.16
1.13
mg/dL
26
26
26
63
51
37
38
41
ug/mL
g/dL
mg/dTT1
1.19
mg/dL
244
238
2005-03-14
H
0.7-1.5
247 - 283
229 - 265
253 - 289
0.70-0.95
0.74 - 0.99
112-122
7-31
7-31
14-38
79-149
73 - 143
0.97-1.36
0.94-1.32
17-34
17-34
17-34
44-81
33-69
32-42
33-43
36-46
1.02-1.36
220 - 268
214-262
mmol/L
U/L
mmol/L
mmol/L
umol/L
umol/L
mmol/L
umol/L
Mmol/L
9/L
mmol/L
umol/L
English
QI] Pretreatment Required
• HDLC
Francais
Qi] Pretraitement necessaire
. HDLC
. Stable pendant 3 jours: ALKP, Ca, CK,NBIL, TBIL.
Ortho-Clnical DJagnosfcs
»flBhww«ffil«w company
2(4)
VITROS DT Control I
DT II • 0uMo avaAuCTEWv yia ra aucmpaTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
Deutsch
QT) Vorbehandlung erforderlich
REF
842 0317
T5652
2006-04-30
2005-08-22
2005-03-14
• HDLC
• Statail far 7 Tage.
• Stabil far 3 Tage: ALKP, Ca, CK, NBIL, TBIL.
• Bis zu 8 Stunden nach der Vorbehandlung stabil: NH3.
Espafiol
Qlij Se requiere tratamiento previo
• HDLC
Cuando se conserva a 2-8°C (36-^)6°F):
• Estable durante 3 dfas: ALKP, Ca, CK, NBIL, TBIL.
• Estable durante 8 horas despues de tratamiento previo: NH3.
Portugues
[Ji] Necessario Tratamento Previo
• HDLC
. Estavel durante 3 dias: ALKP, Ca, CK, NBIL, TBIL.
Italiano
Qij E richiesto il pretrattamento
• HDLC
Dansk
Qij Forbehandling pakraevet
. HDLC
• Stabil i 3 dage: ALKP, Ca, CK, NBIL, TBIL
Svenska
Qg Forbehandling kravs
• HDLC
FOrvaring vid 2-8°C (36-46°F):
. Stabil i 3 dagar: ALKP, Ca, CK, NBIL, TBIL.
3(4)
VITROS DT Control I
DT II • OOAAo avaAuaEWV yia TO auaTrj|jaTa VITROS DT KOI DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
EAAr|ViKci
842 0317
LOT
T5652
2006-04-30
2005-08-22
2005-03-14
HDLC
Ta avaauonraans
Diav arroSniaOtTai at 9£p(JOKpaota 2-8°C (36-46°F):
Iia8£p6 yia 7 wtpt<;.
IiaOtpo yia 3 mitpa;: ALKP, Ca, CK, NBIL, TBIL.
: NH3.
TUrkge
[Ji] Gereken Oni§lem
• HDLC
Sulandinlmif Halde Stabilite
• 7 gan stabildir.
. 3 gQne kadar stabil: ALKP, Ca, CK, NBIL, TBIL.
• On i§lemden sonra 8 gQne kadar stabil: NH3.
Ortho-CIJnScal Diagnostics
4(4)
VITROS DT Control I
REF
DT II • 0uAAo avaAuaEcov yia TO auorrJLiaTa VITROS DT KCII DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
CONV
LOT
842 0317
V5856
2006-12-31
2005-08-22
SI
2005-03-14
GEN
ALB
ALKP
ALT
AMYL
AST
BUN/UREA
Ca
CHE
CHOL
CK
54
55
55
56
57
58
59
60
75
76
58
54
69
70
71
72
73
51
53
57
58
59
60
61
2.6
2.5
103
31
34
36
37
40
99
107
36
19
8.8
9.0
8.9
8.9
9.1
4.21
4.12
167
165
167
188
178
Cl-
53
78
CO2
52
51
54
57
56
57
55
57
58
53
54
55
56
55
56
57
24.6
1.3
1.1
1.1
86
90
70
75
72
85
87
84
92
38
38
37
K+
51
2.9
LAC
59
60
61
59
60
1.5
1.5
1.5
415
398
52
1.1
CREA
CRSC
GGT
GLU
HDLC
LDH
Li
2.3 - 2.9
2.2-2.8
89-117
19-43
22-46
24-48
25-49
28-52
74-124
82 -132
17-55
16-22
8.2 - 9.4
8.4 - 9.6
8.3 - 9.5
8.3 - 9.5
8.5-9.7
3.61 -4.81
3.52 - 4.72
154-180
152-178
154-180
156-220
146-210
73-83
19.6-29.6
1.0-1.6
0.9-1.3
0.9-1.3
70-102
74-106
58-82
63-87
60-84
74-96
76-98
73-95
81 -103
27-49
27-49
26-48
2.6-3.2
1.2-1.8
1.2-1.8
1.2-1.8
367 - 463
350 - 446
0.7-1.5
g/dL
U/L
U/L
U/L
U/L
mg/dL
mg/dL
U/mL
mg/dL
U/L
mmol/L
mmol/L
mg/dL
mg/dL
U/L
mg/dL
mg/dL
mmol/L
mmol/L
U/L
mmol/L|
26
25
103
31
34
36
37
40
99
107
36
6.8
2.20
2.25
2.22
2.22
2.27
4210
4120
4.3
4.3
4.3
188
178
78
24.6
115
97
97
15.4
16.1
70
75
72
4.7
4.8
4.7
5.1
0.98
0.98
0.96
2.9
1.5
1.5
1.5
415
398
1T
23- 29
9/L
22- 28
U/L
89-117
U/L
19- 43
22- 46
24- 48
25- 49
28- 52
U/L
74- 124
82- 132
U/L
17-55
5.7-7.9
mmol/L
mmol/L
2.05- 2.35
2.10- 2.40
2.07- 2.37
2.07- 2.37
2.12- 2.42
U/L
3610- 4810
3520- 4720
mmol/L
4.0- 4.7
3.9- 4.6
4.0- 4.7
U/L
156- 220
146- 210
73-83
mmol/L
19.6-29.6
mmol/L
88-141
|jjmol/L
80- 115
Mmol/L
80- 115
umol/L
12.5- 18.3
13.2 19.0
U/L
58- 82
63- 87
60- 84
4 . 1 • 5.3
mmol/L
4.2- 5.4
4.1- 5.3
4.5- 5.7
0.70- 1.27 mmol/L
0.70- 1.27
0.67- 1.24
2.6 - 3.2
mmol/L
1.2- 1.8
mmol/L
1.2- 1.8
1.2- 1.8
U/L
367- 463
350- 446
mmol/L
0.7-1.5
enheter • IUUPCITIKE'S • Konvansiyonel
I — 5 — I SI • Unites SI • Sl-Einheiten •
1
' Sl-SI-SI-SI-SI-enheterMov<Soe;SI-SI
Value • Resultat • Wtert •
Valor-Valor-Valore•
Vserdi-Varde-Tiuri'Deger
n
Range. The analyzer value
AnalysegerSt erhaltene Wert sollte sich
indenfordette omrade. • Intervall.
Analysinstrumentets varde bor llgga
inom detta omrade. • EOpoc TIUCOV.
H Tipq TOU ovaAuirj TrpETrei va EMTrrrrra
at auTo TO Eupo? TIUWV. • Aralik.
rt
Revised• Mise a jour du •
Revidiert • Revisi6n •
Revideret • Reviderad • Ava8£(jjpner|K£
• Revize edildi
t
, > j _ Supersedes • Remplace la
W c W l version du • Ersetzt •
Baarrai Substituye-Segue-seaSostituisce la versione del • Erstatter •
Ersatter • Yntpioxuei • Yerine ge?er
U/L a 37-C. • I valori U/ml e U/L sono
vid 37"C. • OAE? oi U/mL KCII U/L
OTOUC 37°C. • 37 °C'de turn U/mL
ve U/L.
1(4)
VITROS DT Control 1
REF
DT II • ct>OAAo avaAuaeujv yra Ta ouorrjuaTa VITROS DT m DT II • VITROS DT ve DT II Sistemleri i?in
Test Sayfasi
I
| CONV
GEN
53
57
58
59
58
59
52 |
64
65
66
54
55
58
59
74
75
76
62
63
62
63
64
60
54
55
... Li
L1PA
Mg
Na+
NBIL
NH3
PHOS
TBIL
THEO
TP
TRIG
URIC
miU,
1.1
227
214
231
1.9
1.9
116
1.0
1.1
1.3
102
94
3.7
3.6
1.4
1.3
1.3
10.4
9.3
4.0
3.9
4.0
91
4.2
4.1
H
H
0.7-1.5
209 - 245
196-232
213-249
1.6-2.2
1.6-2.2
111-121
0.3-1.7
0.4-1.8
0.6-2.0
67 -137
59-129
3.1 -4.3
3.0-4.2
0.9-1.9
0.8-1.8
0.8-1.8
7.1-13.7
6.0-12.6
3.5-4.5
3.4-4.4
3.5-4.5
76 -106
3.8-4.6
3.7-4.5
SI
|^
mmol/L
U/L
mg/dL
mmol/L
mg/dL
umol/L
mg/dL
mg/dL
ug/mL
g/dL
mg/dL
mg/dL
1.1
227
214
231
0.78
0.78
116
17
19
22
102
94
1.19
1.16
24
22
22
58
52
40
39
40
1.03
250
244
LOT
842 0317
V5856
2006-12-31
2005-08-22
2005-03-14
W\
0.7-1.5
209 - 245
196-232
213-249
0.66-0.91
0.66 - 0.91
| 111-121
5-29
7-31
10-34
67-137
59-129
1.00-1.39
0.97-1.36
15-32
14-31
14-31
39-76
33-70
35-45
34-44
35-45
0.86-1.20
226 - 274
220 - 268
mmol/L
U/L
mmol/L
mmol/L
umol/L
umol/L
mmol/L
umol/L
umol/L
g/L
mmol/L
pmol/L
English
Qi] Pretreatment Required
• HDLC
Frangais
QTJ Pretraitement necessaire
. HDLC
Stabilite Reconstitute
. Stable pendant 3 jours: ALKP, Ca, CK, NBIL, TBIL.
company
2(4)
VITROS DT Control I
DT II • OuAAo avaAucFEOJV yia ia auaTtipaTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
Deutsch
[]1] Vorbehandlung erforderlich
• HDLC
REF
LOT
842 0317
V5856
2006-12-31
2005-08-22
2005-03-14
Espahol
Qi] Se requiere tratamiento previo
• HDLC
• Estable durante 7 d(as.
• Estable durante 3 dfas: ALKP, Ca, CK, NBIL, TBIL.
Portugues
Qi] Necessario Tratamento Previo
. HDLC
. Estavel durante 3 dias: ALKP, Ca, CK, NBIL, TBIL.
Italiano
Q|| E richiesto il pretrattamento
• HDLC
Conservato a 2-8°C (36-46cF):
a Stabile per 7 giorni.
• Stabile per 3 giorni: ALKP, Ca, CK, NBIL, TBIL
Dansk
[Jij Forbehandling pakraevet
• HDLC
Ved opbevaring ved 2-8° G:
• Stabil i 3 dage: ALKP, Ca, CK, NBIL, TBIL.
Svenska
Qij Forbehandling kravs
• HDLC
FOrvaring vid 2-8°C (36-46°F):
• Stabil i 3 dagar: ALKP, Ca, CK, NBIL, TBIL.
3(4)
VITROS DT Control I
DT II • OuAAo avaAucjEUJV via Ta ouaTii(jaTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
EAAnviKd
REF
842 0317
V5856
2006-12-31
2005-08-22
2005-03-14
Qi]
• HDLC
Diav aTTO9r|KE0£iai at SEppoKpaofa 2-8°C (36-46°F):
• IiaespO yia 7 t)\itpt<;.
• Zia8£p6 yia 3 (]\itpt<;: ALKP, Ca, CK, NBIL, TBIL.
a: NH3.
TUrkge
[JiJ Gereken Oni§lem
• HDLC
• 7 gfln stabildir.
• 3 gone kadar stabil: ALKP, Ca, CK, NBIL, TBIL.
• On i§lemden sonra 8 gone kadar stabil: NH3.
4(4)
VITROS DT Control 1
842 0317
Assay Sheet for VITROS DTand DT II Systems • Fiche de controle pour les Systemes VITROS DTet
VITROS DT e DT II • Kontrolark til VITROS DT og DT II Systems • Kontrollblad for VITROS DToch
DT II • OuAAo avaAucTEUJv yia Ta auaTrjuciTa VITROS DT Kai DT 1I • VITROS DT veDT II Sistemleri icin
X6041
2007-04-30
Test Sayfasi
2005-08-22
SI
CONVj
H
GEN
ALB
ALKP
ALT
AMYL
AST
BUN/UREA
Ca
CHE
CHOL
CK
ClCO2
CREA
CRSC
e
GGT
GLU
HDLC
K+
LAC
LDH
Li
54
55
55
56
57
58
59
60
75
76
58
54
69
70
71
72
73
51
53
57
58
59
60
61
53
52
2.5
2.5
105
27
25
29
27
34
109
108
38
19
9.1
9.0
9.2
9.1
9.1
3.80
3.78
157
161
159
167
157
80
23.9
51
54
57
56
57
55
57
58
53
54
55
56
56
57
51
1.1
1.2
1.1
85
92
73
77
75
88
86
85
92
31
30
2.8
59
60
61
59
60
52
53
1.4
1.4
1.4
434
425
1.1
1.2
H
H
2.2-2.8
2.2-2.8
91-119
15-39
13-37
17-41
15-39
22-46
84-134
83-133
19-57
16-22
8.5-9.7
8.4 - 9.6
8.6 - 9.8
8.5 - 9.7
8.5-9.7
3.20 - 4.40
3.18-4.38
144-170
148-174
146-172
135-199
125-189
75-85
18.9-28.9
0.8-1.4
1.0-1.4
0.9-1.3
69-101
76-108
61 -85
65-89
63-87
77-99
75-97
74-96
81 - 103
20-42
19-41
2.5-3.1
1.1-1.7
1.1-1.7
1.1-1.7
386 - 482
377 - 473
0.7-1.5
0.8-1.6
g/dL
U/L
U/L
U/L
U/L
mg/dL
mg/dL
U/mL
mg/dL
U/L
mmol/L
mmol/L
mg/dL
25
25
105
27
25
29
27
34
109
108
38
6.8
2.27
2.25
2.30
2.27
2.27
3800
3780
4.1
4.2
4.1
167
157
80
23.9
97
mg/dL
106
97
MQ/dL
15.2
16.5
U/L
73
77
75
4.9
4.8
4.7
5.1
mg/dL
mg/dL
0.80
0.78
mmol/L
2.8
mmol/L
1.4
1.4
1.4
434
425
1.1
1.2
U/L
mmol/L
|
2005-06-10
H
22-28
22-28
91-119
15-39
13-37
17-41
15-39
22-46
84-134
83-133
19-57
5.7 - 7.9
2.12-2.42
2.10-2.40
2.15-2.45
2.12-2.42
2.12-2.42
3200 - 4400
3180-4380
3.7-4.4
3.8-4.5
3.8-4.4
135-199
125-189
75-85
18.9-28.9
71 - 124
88-124
80-115
12.4-18.1
13.6-19.3
61 -85
65 - 89
63-87
4.3-5.5
4.2 - 5.4
4.1 -5.3
4.5-5.7
0.52-1.09
0.49-1.06
2.5-3.1
1.1-1.7
1.1-1.7
1.1-1.7
386 - 482
377 - 473
0.7-1.5
0.8-1.6
g/L
U/L
U/L
Ponderales • KonvenSonelle
Einheiten • Convencional •
enheter • IUU|3CITIK£'; • Konvansiyonel
| — g j — | SI • Unites SI • Sl-Einheiten •
1
' SI • SI • SI • SI • SLenheter •
Movd5£? SI • SI
U/L
*
Value • Resultat • Wsrt •
wmmsa
Valor -Valor -Valore •
Vjerdi'Varde-TiurrDefier
l<
U/L
mmol/L
mmol/L
U/L
mmol/L
U/L
mmol/L
mmol/L
(jmol/L
umol/L
umol/L
U/L
mmol/L
,
^ Range. The analyzer value
• Tolerance. La valeur de Panalyseur
ester dentro del rango. • Intervalo. O
Analysinstrumentets varde bflr ligga
inom detta omrade. • EOfxx; TIU&V.
H Tiuri TOU ccvaAurfi Trptrra va EUTrnnEi
as auTo TO Eupo<; tipiiw. • Aralik.
Analizorun degeri bu aralikta olmahdir.
Revisto a • Aggiomato al •
Revideret • Reviderad • Ava9EU)pn,8n,KE
• Revize edildi
t
_ _ * " j ~ Supersedes • Remplace la
I B S f f l l version du-Ersetzti f f l n ™ ! Substituye • Segue-se a •
ErsStter • YrrEpiox UEI • Yerine geosr
determinati a 37-C. • Alle U/ml og
vid 37"C. • OAE? OI U/mL mi
U/L
OTOUS 37°C. • 37 °C'de tiirn U/mL
ve U/L.
mmol/L
mmol/L
mmol/L
U/L
mmol/L
^ O r t h o - a i n i c a l Diagnostics
1(4)
VITROS DT Control 1
REF
Assay Sheet for VITROS DT and DT II Systems • Fiche de controle pour les Systemes VITROS DTet
VITROS DT e DT II • Kontrolark til VITROS [3T og DT II Systems • Kontrollblad i or VITROS DT och
DT II • cpuAAo avaAucreiJdv yia Ta auaTquaTa VITROS DT KCII DT I • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
LOT
842 0317
X6041
2007-04-30
2005-08-22
CONV J
N
GEN
LIPA
57
58
59
Mg
58
59
Na+
NBIL
52
64
65
66
54
55
58
59
75
76
62
63
62
63
64
60
54
55
H3
PHOS
TBIL
THEO
TP
TRIG
URIC
227
216
232
2.0
1.9
117
1.3
1.3
1.7
97
91
3.2
3.2
1.7
1.6
11.5
9.5
3.9
3.9
4.0
111
4.0
3.9
SI
H
209 - 245
198 - 234
214 - 250
1.7-2.3
1.6-2.2
112-122
0.6-2.0
0.6-2.0
1.0-2.4
62-132
56-126
2.6 - 3.8
2.6-3.8
1.2-2.2
1.1 -2.1
8.2-14.8
6.2-12.8
3.4 - 4.4
3.4 - 4.4
3.5-4.5
96-126
3.6 - 4.4
3.5 - 4.3
tJam
U/L
227
216
232
mg/dL
0.82
0.78
mmol/L
mg/dL
117
umol/L
22
22
29
97
91
mg/dL
1.03
1.03
mg/dL
29
27
64
53
39
Mg/mL
g/dL
mg/dL
mg/dL
39
40
1.25
238
232
r^
2005-06-10
™
209 - 245
198-234
214-250
0.70 - 0.95
0.66 - 0.91
112-122
10-34
10-34
17-41
62-132
56-126
0.84-1.23
0.84-1.23
21 -38
19-36
46-82
34-71
34-44
34-44
35-45
1.08-1.42
214-262
208 - 256
U/L
mmol/L
mmol/L
umol/L
umol/L
mmol/L
umol/L
umol/L
g/L
mmol/L
umol/L
English
[Jjj Pretreatment Required
• HDLG
When stored at 2-8°C (36-46T):
• Stable for 3 days: ALKP, Ca, CK, NBIL, TBIL
Frangais
QiJ Pretraitement necessaire
. HDLC
Conservation a 2-8°C (36-46T):
• Stable pendant 3 jours: ALKP, Ca, CK, NBIL, TBIL
2(4)
VITROS DT Control I
y DT II» Foiha do Ensaio para os Sistemas VITROS DT e DT II • Foglietto di dosaggio per Sistemi
DT II • OuAAo avaAuCTEWv via Ta ouaTiiucna VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
Deutsch
Qi] Vorbehandlung erforderlich
. HDLC
REF
LOT
842 0317
X6041
2007-04-30
2005-08-22
2005-06-10
• Stabil fdr 3 Tage: ALKP, Ca, CK, NBIL, TBIL.
Espaftol
Qij Se requiere tratamiento previo
. HDLC
Cuando se conserva a 2-8°C (36-46T):
y
m Estable durante 7 dias.
• Estable durante 3 dias: ALKP, Ca, CK, NBIL, TBIL.
Portugues
Qi] Necessario Tratamento Previo
• HDLC
Estabilidade apos Reconstitui?ao
Quando conservado a uma temperatura entre 2 e 8"C:
Italiano
Qg E- richiesto il pretrattamento
• HDLC
Conservato a 2-8°C (36^16°F):
Dansk
[ji] Forbehandling pakraevet
• HDLC
Svenska
rjg Forbehandling kravs
• HDLC
. Stabil i 3 dagar: ALKP, Ca, CK, NBIL, TBIL.
Ortho-Qinkal Diagnostics
3(4)
VITROS DT Control I
DT II • 0uAAo avaAuCTEiov yia Ta 0uaTrj|jaTa VITROS DT KCII DT II • VITROS DT ve DT 11 Sisternleri igin
Test Sayfasi
842 0317
X6041
2007-04-30
2005-08-22
2005-06-10
HDLC
Orav aTro6r)K£taai at StppoKpacrfa 2-8°C (36-46°F):
• IiaSepo yia 3 r\\itpt<;: ALKP, Ca, CK, NBIL, TBIL
• lTa9tp6 yia 8 lOpec; (Jtid tnv TTpo£TTE5£PYao'a: NH3.
TUrkge
Ql| Gereken dni§lem
• HDLC
• 7 gQn stabildir.
• 3 gone kadarstabil: ALKP, Ca, CK, NBIL, TBIL.
• On iflemden sonra 8 gQne kadar stabil: NH3.
Ortho-ClinicalB
4(4)
VITROS DT Control II
REF
DT II • 4>uAAo avaAucrecov yia TO ouCTTrj|jaTa VITROS DT KCII DT II • VITROS DT ve DT II Sistemleri icin
Test Sayfasi
ALB
ALKP
ALT
AMYL
AST
UN/UREA
Ca
CHE
CHOL
CK
ClCO2
CREA
CRSC
Fe
GT
GLU
HDLC
K+
LAC
LDH
Li
LIPA
R5482
2005-09-30
2005-08-22
SI
CONV
GEN
54
55
55
56
57
58
59
75
58
54
69
70
71
72
73
51
53
57
58
59
60
61
53
52
51
54
57
56
57
55
57
53
54
55
56
55
56
57
51
59
60
61
59
60
52
53
57
58
LOT
144 8042
2005-03-14
J
4.5
4.4
4.0- 5.0
3.9- 4.9
g/dL
427
337-517
196
197
197
196
221
172- 222
172- 222
171 - 221
274 - 374
184-234
43-55
11.4 •13.0
11.8 •13.4
11.5 •13.1
11.4 •13.0
11.7 •13.3
6.79 -8.59
6.71 -8.51
227- 271
224- 268
220- 264
745 -997
837- 1089
103-113
10.9-20.9
U/L
U/L
324
209
49
12.2
12.6
12.3
12.2
12.5
7.69
7.61
249
246
242
871
963
108
15.9
5.1
6.2
6.2
245
241
471
506
303
302
299
315
57
51
55
5.5
3.8
4.1
4.0
1464
1367
2.3
2.4
705
671
171 •
4.1-6.1
5.7- 6.7
5.7- 6.7
219- 271
215- 267
438- 504
473- 539
282 •324
281 •323
278 • 320
294 • 3 3 6
43- 71
37- 65
4 1 • 69
5.2-5.8
3.3 •4.3
3.6 • 4.6
3.5 •4.5
1325 • 1603
1228 •1506
1.7 • 2.9
1.8 3.0
641- 769
607- 735
U/L
U/L
mg/dL
mg/dL
U/mL
mg/dL
U/L
mmol/L
mmol/L
mg/dL
mg/dL
U/L
mg/dL
mg/dL
mmol/L
mmol/L
U/L
mmol/L
U/L
45
44
427
196
197
197
196
324
209
17.5
3.04
3.14
3.07
3.04
3.12
7690
7610
6.4
6.4
6.3
871
963
108
15.9
451
548
548
43.9
43.1
471
506
16.8
16.8
16.6
17.5
1.47
1.32
1.42
5.5
3.8
4.1
4.0
1464
1367
2.3
2.4
705
671
40- 50
39- 49
337-517
171 - 221
172- 222
172- 222
171 - 221
274 - 374
184-234
15.3-19.6
2.84- 3.24
2.94- 3.34
2.87 • 3.27
2.84- 3.24
2.92- 3.32
6790- 8590
6710- 8510
5.9- 7.0
5.8- 6.9
5.7- 6.8
745 •997
837- 1089
103-113
10.9-20.9
362 - 539
504- 592
504- 592
39.2- 48.5
38.5- 47.8
438- 504
473- 539
15.7- 18.0
15.6- 17.9
15.4- 17.8
16.3- 18.7
1 . 1 1 • 1.84
0.96- 1.68
1.06- 1.78
5.2-5.8
3.3- 4.3
3.6- 4.6
3.5 • 4.5
1325- 1603
1228- 1506
1.7- 2.9
1.8- 3.0
641 • 769
607- 735
g/L
U/L
U/L
'
enheter • Iuu|3ariK££ • Konvansiyonel
| — S j — i SI • Unites SI • Sl-Einheiten •
'
• SI
U/L
U/L
mmol/L
mmol/L
U/L
mmol/L
U/L
mmol/L
mmol/L
Mmol/L
Mmol/L
Mmol/L
U/L
mmol/L
mmol/L
.._*_
" * "
Valor -Valor -ValoreVasrdi • Varde • Tiun. • Deger
h
M Range. The analyzer value
should tell within this range.
doit se trouver dans cet intervalle. Messbereich. Der mit dem
rientrare in questo intervallo. • Omr&de.
Analyseinstrumentets vasrdi skal ligge
inden fbrdette omrade. • Intervall.
inom detta omrade. • EOpo? TIUOOV.
H Tiprj TOU avoAuTii TTPETTEI va £|jTrim£i
at auroTOtupcx; Tipuw. • Aralik.
Revideret • Reviderad • Ava6EU)pr|er|K£
• Revize edildi
t
if%-~ Supersedes • Remplace la
• 9
version du • Ersetzt •
fflfflTt™I Substituye-Segue-seaSostituisce la versione del • Erstatter •
Ersatter • Ympioxuti • Yerine gecer
determineesaST-C. • Enzymaktivitaten
vid 37"C. • Otes oi U/mL KCII U/L
crrou? 37°C. • 37 "C'de turn U/mL
ve U/L.
mmol/L
mmol/L
•U/L
mmol/L
U/L
1(4)
REF
DT II • OuAAo avaAuaewv yia Ta aucniiuaTa VITROS DT KCH DT II • VITROS DT ve DT II Sistemleri igin
TestSayfasi
CONV
Mg
Na+
NBIL
NH3
PHOS
BIL
THEO
TP
TRIG
URIC
GEN
58
59
52
64
65
54
55
58
59
74
75
76
62
62
63
64
60
54
55
4.7
4.8
137
14.0
14.9
225
211
6.6
6.6
12.8
12.8
12.9
22.9
7.0
6.8
7.0
232
10.6
10.3
4.2-5.2
4.3 - 5.3
131-143
12.4-15.6
13.3-16.5
150-300
136-286
5.4-7.8
5.4 - 7.8
11.2-14.4
11.2-14.4
11.3-14.5
18.7-27.1
6.5-7.5
6.3 - 7.3
6.5-7.5
208 - 256
9.8-11.4
9.5-11.1
SI
mg/dL
mmol/L
mg/dL
umol/L
mg/dL
mg/dL
ug/mL
g/dL
mg/dL
mg/dL
1.93
1.97
137
239
255
225
211
2.13
2.13
219
219
221
127
70
68
70
2.62
630
613
1.73- 2.14
1.77- 2.18
131-143
212- 267
227- 282
150- 300
136- 286
1.74- 2.52
1.74- 2.52
192- 246
192- 246
193- 248
104-150
65- 75
63- 73
65- 75
2.35 - 2.89
583- 678
565- 660
144 8042
R5482
2005-09-30
2005-08-22
2005-03-14
mmol/L
mmol/L
umol/L
umol/L
mmol/L
pmol/L
(jmol/L
g/L
mmol/L
umol/L
English
QIJ Pretreatment Required
• HDLC
When stored at 2-8°C (36-46T):
Francjais
Tj] Pretraitement necessaire
. HDLC
Conservation a 2-8°C (36~46°F):
. Stable pendant 3 Jours: ALKP, Ca, CK, NBIL, TBIL.
• Stable pendant 8 heures apres le pretraitement: NH3..
Deutsch
Og Vorbehandlung erforderlich
• HDLC
Bei Lagerung zwisohen 2 und 8 °C:
2(4)
Assay Sheet for VITROS DT and DT II Systems • Fiche de contr6le pour les Systemes VITROS DT et
DT II • ct>uAAo avaAuCTEtov yia TO aucnriiJaTa VITROS DT xai DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
Espaflol
[]ij Se requiere tratamiento previo
• HDLC
144 8042
LOT
R5482
2005-09-30
2005-08-22
2005-03-14
• Estable durante 3 dlas: ALKP, Ca, CK, NBIL, TBIL.
Portugues
QTj Necessario Tratamento Previo
• HDLC
Estabilidade apos Reconstitui?ao
Quando oonservado a uma temperatura entre 2 e 8°C:
Italiano
QjJ £ richiesto il pretrattamento
• HDLC
Conservato a 2-S°C (36-46°F):
Dansk
[Jij Forbehandling pakraevet
• HDLC
Svenska
QT] Forbehandling kravs
• HDLC
Fotvaring vid 2-8°C (36-46°F):
• Stabil i 3 dagar: ALKP, Ca, CK, NBIL, TBIL.
I ATraiTErrai Trpo£Tr£$£pY<rcna
HDLC
ETa8EpoTr|Ta ava<?uo~Tao~r|£
Diav arro9r|K£0£iai O£ 6£puoKpaola 2-8°C (36-46°F):
Im0£p6 yia 7 r\\itpzt;.
Iia8£p6 yia 3 r]\itpt<;: ALKP, Ca, CK, NBIL, TBIL.
:NH3.
ny
3(4)
DT II • OuAAo avaAOaEiDV yia la ouoTiifjaTa VITROS DT Kai DT II • VITROS DT ve DT II Sistemleri igin
Test Sayfasi
TUrkce
rjg Gereken Oni§lem
• HDLC
REF
144 8042
R5482
2005-09-30
2005-08-22
2005-03-14
Sulandinlmis. Halde Stabilite
2-8 "C'de saklandiQinda:
• 7 gGn stabildir.
• 3 gone kadar stabil: ALKP, Ca, CK, NBIL, TBIL.
• On isjemden sonra 8 gUne kadar stabil: NH3.
t
OrthoClinkal Diagnostics
4(4)
REF
y DT II • Foiha d

instructions for use

Transcription

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