Instrumentation Laboratory’s ACL ADVANCE/FUTURA are fully automated random-access analyzers for... in coagulation testing. The principle of turbidimetric (coagulometric) clot... FIBRINOGEN (FIBRINOGEN-C) – ADVANCE/FUTURA

Instrumentation Laboratory’s ACL ADVANCE/FUTURA are fully automated random-access analyzers for... in coagulation testing. The principle of turbidimetric (coagulometric) clot... FIBRINOGEN (FIBRINOGEN-C) – ADVANCE/FUTURA

FIBRINOGEN (FIBRINOGEN-C) – ADVANCE/FUTURATM
PRINCIPLE
Instrumentation Laboratory’s ACL ADVANCE/FUTURA are fully automated random-access analyzers for use
in coagulation testing. The principle of turbidimetric (coagulometric) clot detection is used to measure and
record the amount of time required for a plasma specimen to clot. This technique assesses coagulation endpoint
by measuring change in optical density.
The Fibrinogen-C test , based on the Clauss method, uses an excess of thrombin to convert fibrinogen to fibrin
in diluted plasma. At high thrombin and low fibrinogen concentration, the rate of reaction is a function of
fibrinogen concentration.
Fibrinogen (Factor I), a phase-reactive protein, is converted to fibrin by the action of thrombin (Factor IIa).
Several congenital abnormalities of fibrinogen result in impaired conversion of fibrinogen to fibrin during blood
coagulation. Fibrinogen is also a useful marker in the evaluation of several disease states including
Disseminated Intravascular Coagulation(DIC), liver disease, inflammatory diseases and malignancies. High
levels of fibrinogen are associated with an increased risk for cardiovascular disease. Increased levels are also
found during pregnancy and oral contraceptive use, while reduced levels are found during DIC, liver disease
and thrombolytic therapy.
SPECIMEN
500 μl (minimum) of 3.2 % Sodium citrated (9:1 blood:anticoagulant ratio), platelet-poor plasma
(<10,000 plts/μl). Centrifuge at 3300 RPMs for 15 minutes.
Specimens may also be centrifuged in the StatSpin Express 2 at the “ Hard Spin” setting of 180 seconds.
Refer to STATSPIN EXPRESS PRIMARY TUBE COAGULATION CENTRIFUGE for more information.
Stability:
TEST
PT
PTT, and all other
coagulation tests.
Refrigerated (2 – 8 oC) or
Room temperature (18 - 24 oC)
(Regardless of centrifugation.)
24 hours in an unopened tube
4 hours
–70 oC
(Double Centrifuged)
6 months
6 months
SPECIMEN REJECTION CRITERIA
See SPECIMEN HANDLING for COAGULATION for complete details.
CHARGING INSTRUCTIONS
1.
Access LIS using ID and Password.
2.
Select –Orders and “O” –Order Entry <enter/return>.
3.
LIS defaults to Order Add.
4.
On the pop-up screen, enter the medical record number (MRN), or enter the patient’s name in the
appropriate fields; press F12.
5.
Choose the correct billing number.
a.
INPATIENTS:
1)
Choose the correct billing (admission) number to match the number on the requisition
2)
Press <enter/return>.
3)
Bypass all previous orders by pressing F1.
b.
6.
OUTPATIENTS
1)
Choose the correct billing number to match the number on the requisition.
2)
If no billing number is listed, log into IDX system to assign one.
Use the TAB key to advance cursor and enter all pertinent data required and advance to TESTS
ORDERED field.
a.
Enter 5 to enter Hematology template.
b.
Enter S to enter Coagulation template.
c.
Enter E to choose Fibrinogen (FBGN).
Alternatively, from the Order Entry screen, turn off the order menu by pressing Control and A
simultaneously. Then type in the test code FBGN.
1.
Press F7 to collect and receive the specimen. Enter the appropriate information. Press F12 twice.
2.
If the anticoagulant the patient is receiving is written on requisition, include it under the COMMENT
CODE of the Order Entry screen.
3.
Press F12.
4.
Confirm Y/N (yes/no). Select appropriate label printer for labels. Press Enter.
REAGENTS/MATERIALS
1.
HemosILTM Fibrinogen-C kit (Cat. #0008469110-Beckman).
The kit consists of
a.
Bovine Thrombin (C# 0008469120): 8 x 2 ml vials of lyophilized bovine thrombin (35
UNIH/ml) with bovine albumin, calcium chloride, buffer and stabilizers.
b.
Abnormal control plasma (for Special Coag use only),(Cat #0008469122): 2 x 1 ml vials of
lyophilized human citrated plasma containing a reduced level of fibrinogen with buffer and
stablizers.
Unopened vials stable until expiration date when stored at 2 – 8 oC.
CAUTION: The material in this product was tested by FDA approved test methods and found nonreactive for Hepatitis B Surface Antigen(HBsAg), Anti-HCV and HIV antibodies. Handle as if
potentially infectious.
Avoid contact with skin and eyes. Wear suitable protective clothing.
Discard into biohazard waste container.
This product is for in-vitro diagnostic use.
2.
HemosILTM Cleaning Agent (Clean “B”) (Cat. #0009832700-Beckman).
Sodium hypochlorite solution. Contains <5% available chlorine. Avoid contact with skin and eyes.
Stable until expiration date on label.
3.
HemosILTM Factor Diluent (Cat. # 0009757600-Beckman).
Saline solution and less than 0.1 % sodium azide.
Stable until expiration date on label.
CAUTION: Avoid contact with skin and eyes. Wear suitable protective clothing.
Contains sodium azide. Flush with water if disposing into drains.
1.
NCCLS Type II Water (Fisher).
4.
HemosILTM Rinse Solution (Cat. #0020009320-Beckman)
Surfactant and less than 0.1% of sodium azide.
Stable until expiration date on label.
CAUTION: Avoid contact with skin and eyes. Wear suitable protective clothing.
Contains sodium azide. Flush with water if disposing into drain.
3.
2.0-ml sample cups (Cat. #5575100-Beckman).
4.
Plastic tubes-12x75mm (Warehouse)
1.
ACL Cuvettes (Cat. # 18901200-Beckman)
QUALITY CONTROL
The ADVANCE is the primary coagulation instrument. Controls are run at the beginning of each 8-hour shift
and when new reagents are placed on the instrument. (Refer to QUALITY CONTROL, Miscellaneous Manual,
for complete details.) Modified Westgard Rules are utilized to determine if controls are acceptable and satisfy
all selected rules.
The ACL FUTURA is the backup analyzer for the ACL ADVANCE for routine coagulation tests.
Comparative analysis between the ACL ADVANCE and FUTURA allows the following differences between
the patient results of the two instruments: Fibrinogen < 15%. Comparative analysis is performed every 6
months.
CAUTION: The control material contains a possible infectious risk. Handle as if potentially infectious.
1.
HemosILTM Routine Control Level 1 UNASSAYED , (Cat. #0020005600-Beckman)
Control is lyophilized citrated human plasma from healthy donors. Values for PT, APTT, and fibrinogen
are within normal range. Unopened vial is stable until the date indicated on the label if stored at 2o-8
o
C.
2.
HemosILTM Low Fibrinogen Control, (Cat. #0020004200-Beckman)
Control consists of lyophilized fresh human citrated plasma containing a reduced level of fibrinogen.
Unopened vial is stable until the date indicated on the label if stored at 2o-8 oC.
REAGENT PREPARATION, STORAGE AND STABILITY
1.
HemosILTM Fib-C Bovine thrombin.
a.
Reconstitute vial with 2.0 ml NCCLS Type II water.
b.
Replace stopper and swirl gently.
c.
Allow reagent to stand at room temperature for 30 minutes.
d.
Mix gently by inversion before use. Do not shake.
Stability:
a.
Unopened vial is stable until the expiration date shown on the vial when stored at 2 – 8 oC.
b.
After reconstitution: 3 days at 2 – 8 oC in the original vial.
c.
3 days at 15 oC on the Advance/Futura instruments.
2.
HemosILTM Abnormal control plasma (for Special Coag use only).
a.
Reconstitute vial with 1.0 ml NCCLS Type II water.
b.
Replace stopper and swirl gently.
c.
Allow reagent to stand at room temperature for 30 minutes.
d.
Mix gently by inversion before use. Do not shake.
Stability:
a.
After reconstitution: 4 hours at 15 - 25 oC in the original vial
b.
: 7 days at -20 oC in the original vial.
3.
1:8 Clean B:
Prepare fresh daily. Add 1 ml Cleaning Agent(Clean B) to 7 ml sterile water in a 10
ml vial suitable for the Futura/Advance reagent rack
4.
Controls
a.
Reconstitute one vial each with 1.0 ml NCCLS Type II water.
b.
Replace stopper. Swirl gently. Avoid foam formation
c.
Allow to stand for 30 minutes at room temperature.
Stability after reconsitution:
a.
HemosILTM Routine Control Level 1 UNASSAYED
b.
HemosILTM Low Fibrinogen Control
8 hours at 2o-8oC.
4 hours at room temperature.
CALIBRATION
Fibrinogen-C calibration is performed with each new lot number of Fibrinogen-C reagent , when there is a
QC failure/shift, or when major instrument maintenance results in a QC failure/shift.
See FIBRINOGEN-C CALIBRATION-ADVANCE/FUTURATM, , page 13 for complete procedure.
TEST PROCEDURE
NOTE: Quality control must be run at the beginning of each 8-hour shift and any time fresh reagent is placed on
the system.
1.
Perform Daily and other Maintenance, if required. (See ADVANCE/FUTURA MAINTENANCE
procedure.)
2.
Reconstitute reagent and controls (see REAGENT PREPARATION).
3.
Check/Load the reagents as follows:
a.
Fibrinogen-C reagent
b.
Clean B 1:8 Prepare fresh daily!
c.
Factor Diluent (Room Temperature rack)
Reagent position # 12
Reagent position # 6
Reagent position # 2 ( RT rack)
1.
Place samples on a sample rack, with bar code label facing open slots in rack. Quality Control or
microspecimens (NICU) are placed in 2.0-ml cups.
Minimum volume in cups is 0.5 ml.
2.
From Main screen on ADVANCE/FUTURA, press F6 NEXT to clear screen.
3.
Load and run bar-coded specimens as follows:
Press F2 BAR CODE to turn bar code reader on.
Wait until red line appears on the left side of the sample loading area, indicating that the bar
code reader is “on”.
c.
Insert rack onto loading area (in any row) until a clicking sound is heard. The LED on the
selected row turns from green to red, indicating that the rack has been locked into place.
d.
Press ENTER to continue.
a.
Enter yes if the bar codes have been read correctly. Question marks appearing next to tests
indicate that the Futura received instructions from the LIS to run that test.
f.
Press F3 START, then ENTER.
a.
b.
1.
Program and run the quality control as follows:
a.
Press ENTER to move cursor to sample ID field. This can be done from a clear programming
screen if controls are on a separate rack, or from a screen which has bar coded specimens already
programmed if that is the rack where QC are located.
b.
Press ENTER as many times as is necessary to bring cursor to sample ID field corresponding to
the location of the control specimen.
c.
Press Insert key to bring up QC choices.
d.
Arrow down (↓) to highlight desired control and press ENTER.
1)
LEVEL 1
2)
LEVEL 2
3)
LOW FIB
e.
Press Tab key twice to reach “Requested Test” field.
f.
Press Insert key. Use arrow down key to highlight the test corresponding to the QC, and press
ENTER. Repeat for each QC specimen. Use the following chart to run PT,PTT FBGN qc for
each shift.
g.
QC
LEVEL 1
LEVEL 2
LOW FIB
8.
Test Code
LEVEL 1 (PT/FBGN/PTT)
LEVEL 2 (PT/PTT)
FBGN
Program and run the quality control as follows (con’t):
h.
i.
j.
Press F3 START. The computer prompts the user to “Insert Loaded Sample Rack.” Insert rack
onto loading area (in any row) until a clicking sound is heard.
Press ESC.
Press F3 START once again, then ENTER.
9.
Program patient specimens manually (without bar codes) as follows:
a.
Press ENTER as many times as is necessary to bring cursor to Sample ID field corresponding to
the location of the patient specimen.
b.
Type in specimen ID # (use accession # for results to be uploaded to the LIS after testing).
c.
Press Tab key twice to reach “Requested Test” field.
d.
Press Insert key.
e.
Use arrow down (↓) key to highlight desired test profile and press ENTER.
a.
Repeat Steps (a) - (e) to program all specimens.
b.
Press F3 START. The computer prompts the user to “Insert Loaded Sample Rack.” Insert rack
onto loading area (in any row) until a clicking sound is heard.
c.
Press ESC.
d.
Press F3 START once again, then ENTER.
10.
Tests in process will flash on instrument’s computer screen. When testing is complete, a “v” appears
next to the test, and the rack is released.
REVIEWING RESULTS ON THE FUTURA
1.
Press ALT and R simultaneously, and use the arrow down (È) key to select VALIDATED. Press
ENTER.
2.
Press END key to view results at the end of the VALIDATED list.
3.
Check flags when present in the column at the far right of results as follows:
a.
Select the flagged specimen using arrow key to move cursor.
b.
Press F9 MORE DETAIL.
c.
Press F9 SHOW CURVE.
d.
Press ESC to return.
e.
Press F7 to view error message or short report.
f.
Look up error message or short report in the OPERATOR’S MANUAL, Section 11. For each
error message or short report, the manual lists a description/possible cause and operator action.
Follow suggested “operator action” before reporting results.
VERIFYING QUALITY CONTROL
Verify QC in the LIS before reporting patient results.
1.
Access the LIS using your ID/password.
2.
Highlight 8-INTERFACE, INTERFACES MENU, and press ENTER.
3.
Highlight the appropriate instrument (ACL-ADVANCE-COAG or ACL-FUTURA-COAG), and press
ENTER.
4.
Highlight LOOK, and press ENTER.
5.
Use the spacebar to change “WHAT TO DISPLAY” from ALL to NOT POSTED, and press F12.
6.
Highlight the QC corresponding to the appropriate QC code and press ENTER.
7.
Verify and Post the QC to the LIS by pressing the SHIFT + keys simultaneously.
8.
Modified Westgard Rules are utilized to determine if controls are acceptable and satisfy all selected
rules. Refer to QUALITY CONTROL, Miscellaneous Manual, for complete details.
1.
If the QC results are acceptable, they are written to the database without any additional data.
2.
If the QC results are unacceptable:
a.
Stop patient testing. Do not verify results.
b.
Prepare fresh QC material and/or reagents, and repeat testing.
c.
Consult the Core Laboratory Supervisor. Recalibration may be necessary.
d.
Call Technical Service 1-800-526-7694.
1)
Advance: System ID # 477244. Serial #04070937.
1)
Futura: System ID # 2616. Serial #70400583.
REPORTING RESULTS
1.
Access the LIS system, using your ID and password.
2.
Select 3-Results and enter “V”-View/Enter results by Sel. Tests.
3.
The ENTER option will be highlighted. Press Enter key.
1.
The cursor is now in the following area “Select tests by” TEMPLATE (default). Use the spacebar to
change to TEST if desired.
5.
Advance the cursor to the next field and enter COAGA (if TEMPLATE was selected), or FBGN (if
TEST was selected).
2.
Press ENTER to advance the cursor to the STATUS field. “Pend & Non” is displayed.
7.
Move the cursor to “From order #
date.
to
, Enter the order #, or bypass to choose all from current
8.
Press F12 twice.
9.
Use the down arrow to advance to the required Order #, or press Enter, then F5 to review each order.
3.
Refer to PROCEDURAL NOTES for further steps to take if FBGN results in the LIS are flashing or not
present; or if fibrinogen results are < 80 mg/dl or > 600 mg/dl (“T” code will be present in column to the
right of results on the Advance/Futura to indicate results outside linearity).
11.
If a comment is needed, it can be entered after any result by pressing the ] key to see a list of canned
messages or the \ key to enter a free text message. Press F12 to confirm the addition of the comment to
the test report. If an internal message is indicated (document any time you check for a clot, check a
label, or verify by repeat), enter a question mark in front of the free text message, and that message will
not appear on the report.
12.
Hepadsorbed plasmas will have a prompt, and a pop-up window requiring the Technologist to include
the code that the plasma was hepadsorbed before testing. (Refer to HEPADSORB procedure for
complete details.)
13.
Verify manually entered or posted results with the semicolon (;) key or individually with the ([) key. A
“V” will appear after the test.
14.
Document called results (critical values, OL locations) by simultaneously pressing the CTRL and “C”
keys. The cursor moves to the Call area, enter “Y”. A new screen opens up for documentation. Enter
all information. See PROCEDURAL NOTES for more details.
15.
Press F12 twice to return to the worklist. Press F12 again to “Confirm modification to record? (Y/N)” Enter Y.
16.
REFERENCE RANGES
ADULTS
PEDIATRICS at :
Day 1
Month 1
Month 6
EXPECTED NORMAL RANGE
(mg/dl)
203 - 472
CRITICAL VALUES
(mg/dl)
< 100
167 - 399
162 - 378
150 - 387
< 100
< 100
< 100
LINEARITY AND REPORTABLE RANGES
FBGN
FIB-LO
FIB-HI
80 –600 mg/dl
40 – 300 mg/dl
160 – 1200 mg/dl
LIMITATIONS OF THE PROCEDURE
1.
Visible hemolysis may indicate possible clotting factor activation and should not be tested.
1.
Grossly lipemic specimens may cause the Advance or FuturaTM to fail. Airfuge lipemic samples.
Rerun. Include @CLAR comment (refer to SPECIMEN HANDLING FOR COAGULATION).
Note: It may be necessary to request that the patient be redrawn for 2 coag tubes to get sufficient
volume
of plasma for airfuging.
3.
Fibrinogen-C results are not affected by heparin up to 1.0 U/ml, triglycerides up to 1022 mg/dl or bilirubin
up to 19.6 mg/dl. Fibrinogen-C results may be affected by degradation products(fibrin or fibrinogen) in the
plasma assayed.
PROCEDURAL NOTES
1. Use the following table to assist in reporting Fibrinogen results:
Reportable Linearity
FBGN
FBGN:
80.0 – 600.0 mg/dl
Check reagent levels.
FIB-LO:
40.00 –300.0 mg/dl
Cancel if hemolyzed.
FIB-HI:
60.0 – 1200.0 mg/dl
Airfuge specimen if grossly lipemic.
FBGN < 100.0 mg/dl
(Critical result-flashing in
LIS)
If result is <80, a “T” code
will appear to the right of
the result in the
Advance/Futura to indicate
below linearity
FBGN > 600.0 mg/dl
( “T” code will appear in
column to right of results in
Advance/Futura result
screen)
•
•
•
Repeat as FIB-LO.
?clotÆcancel
•
•
Report value
•
Instrument will
automatically rerun test
as FIB-HI
Report value
up to 1200 mg/dl
If FIB-HI value > 1200,
report as >1200 mg/dl
Critical Results
< 100.0 mg/dl
FBGN fails due to “E” error
(CHECK REAGENT BOTTLE
FOR BUBBLES AND
ADEQUATE VOLUME !)
•
•
•
•
•
•
Repeat FBGN.
If FBGN fails a second time, run
test as FIB-LO and report result.
If FIB-LO fails, you MUST rerun
as FIB-LO a second time.
?clotÆcancel
Report FBGN < 40 mg/dl, with
appended canned message
@FBGN *
Call and document in LIS.
*All FBGN < 40 mg/dl must have the canned message @FBGN appended:
“Fibrinogens < 40 mg/dl may be due to specimen contamination, low/dysfunctional fibrinogen, liver failure,
DIC, and other disease processes.”
2.
Beckman Customer Service may be reached by calling 1-800-526-7694,
Advance:
System ID #477244 Serial #04070937
Futura:
System ID #2616
Serial #70400583
3.
Minimum volume requirement is 0.5 ml. USE ONLY 2.0-ml SAMPLE CUPS. Do not use microcups.
The sensors do not sense the microcups properly, and the probe may crash. Damaged or misaligned
probes necessitate a service call.
1.
Critical Values: Call all critical values as soon as they have been confirmed on repeat analysis, and
document in the LIS. Press CTRL C to enter the Call screen.
4.
After the specimens have been bar coded, or manually programmed, the ADVANCE/FUTURA receives
the LIS order and then displays the tests with a “?” in the TEST REQUESTED field of the main screen.
If no communication occurs between the instrument and LIS, only the default test appears on the test
screen. In this case, the operator must check the LIS pending list (Template CoagA), and manually
enter the required tests using the Insert key. If no tests are manually entered, only the PT runs as the
default test.
3.
The LIS assigns:
a.
“16” at the end of all accession numbers for the primary draw tubes for Coagulation.
b.
“B1” for the hepadsorb aliquot labels--are not recognized for pending tests by the instruments.
Therefore, it is necessary to check the LIS for tests ordered every time a hepadsorbed specimen
is run. Do not change the “B1” ending in the instrument. UCHC records must indicate that the
specimen was run hepadsorbed, when ordered as such. The hepadsorb procedure will remove all
heparin from plasma, whether the heparin was given to the patient therapeutically, or is from a
contaminated line draw (see HEPADSORB procedure for further details.)
4.
The ADVANCE/FUTURA automatically uploads results to the LIS at one-minute intervals. Results
flagged with “^” have been uploaded to the LIS. Results flagged with “+” have not yet been uploaded
to the LIS.
5.
Internal Comments: Any time a specimen is rechecked by repeat analysis, applicator sticks, document
this action as follows:
a.
With the cursor highlighting test of interest, press the backslash (\) key to open the pop-up
window.
b.
Begin typing with a question mark (?) followed by the comment. The question mark prevents
the comment from appearing on the final report, and is therefore used for internal laboratory
comments only.
CALIBRATION
Fibrinogen-C calibration is performed with each new lot number of Fibrinogen-C reagent , when there is a
QC failure/shift, or when major instrument maintenance results in a QC failure/shift.
1.
Reconstitute:
.
Two vials Fib-C Bovine Thrombin
.
One vial Abnormal Control Plasma (from the Fib-C kit)
.
Two vials of Calibration Plasma according to Reagent Preparation procedure above.
2.
3.
3.
Pool:
a.
The two vials of Fib-C Bovine Thrombin into one of the reconstituted vials.
b.
The two vials of Calibration Plasmas into one of the reconstituted vials.
Place the reagents on the Futura/Advance as follows:
Position
Reagent
Pooled Calibration Plasma
**NOTE** Position # 9
Factor Diluent (pour fresh diluent into 30-ml
# 2, Room Temperature rack
reagent bottle)
Fib-C Bovine Thrombin
Position # 12
Clean B 1:8
Position # 6
** NOTE**: Check reagent position screen to determine if Calibration Plasma is programmed in
position # 9 as follows:
a. Press ALT S. Arrow down to highlight POSITIONS. Press ENTER.
b. If Calibration Plasma is not listed in Position # 9, arrow down to move cursor to # 9.
c. Press INSERT key. Arrow down to select Calibration Plasma. Press ENTER.
d. Press TAB to move cusor to Arm field. Enter L. Press F10 SAVE.
e. Press escape to reach main screen.
Enter Calibration Target Values.
a.
Press ALT S from the Main Menu to display Set-up Menu.
b.
Highlight TESTS and press ENTER to display Test Summary screen.
c.
Highlight factor to be calibrated and press ENTER to display the Test Definition screen.
d.
Press F4 CALIB DEF to display the Calibration Definition screen.
e.
Move cursor to Target Values column
f.
Calculate the values for Fibbrinogen-C as follows:
Concentration
Target Values for
Fibrinogen-C
100 %
Insert Value x 1.5
60 %
New 100% value x 0.6
40 %
New 100% value x 0.4
30 %
New 100% value x 0.3
20 %
New 100% value x 0.2
g.
h.
i.
j.
k.
4.
Input calculated values into the appropriate fields in the Target column.
Press F10 SAVE.
Press ENTER to return to the Test Definition screen.
Use arrow down key to move cursor to Test Range field.
Press tab key to move cursor to the high value of the test range and input new 100% target
value.
Start Calibration.
a.
From Main Menu, press ALT C to display the Calibration Menu.
b.
Highlight Factor to be calibrated and press Enter to display the Action Menu.
c.
Highlight Calibration Run and press ENTER to display the screen or press F9 CAL RUN.
d.
Confirm placement of liquids. New Target Values will not be displayed until calibration is
complete.
e.
Press F3 START to start the calibration. A confirmation message will appear.
f.
Choose YES and press ENTER to begin calibration.
1.
Review calibration curve. “R” value should be > 0.985. (See CALIBRATION PROCEDURAL
NOTES if value is <0.985).
6.
Press F10 SAVE.
7.
Press Print SCRN to print screen.
8.
Press F8 SHOW CURVE to view FIB-C Calibration Curve.
9.
Press PRINT SCRN to print screen.
10.
File hard copies in “FUTURA/ADVANCE CALIBRATION S” notebooks, located in Special
Coagulation.
Include on the sheet: Lot #’s of the FIB-C kit and Calibration Plasma.
11.
Run Routine Normal Control Level 1 and Low Fibrinogen Control as instructed to ensure that the IL
System is properly calibrated. The Abnormal Control Plasma that comes in the Fibrinogen-C kit may be
prepared and analyzed also, if desired , and the value compared to the package insert value.
CALIBRATION PROCEDURAL NOTES
1.
There should be NO flags and “r” must be > 0.985. If there are flags present after calibration, or if “r” is
<0.985,
a.
Repeat the calibration with fresh PC Reagent and Calibration Plasma.
b.
Consult Core Lab Supervisor.
c.
Call Technical Service 1-800-526-7694. FUTURA: System ID #2616. Serial #70400583.
ADVANCE: System ID #477244 Serial # 04070937.
1.
If the new lot Calibration Target Values were not entered during the Calibration Procedure, press F11
NEW LOT on the Calibration Run screen to update calibration statistics and Calibration Plasma (NPP)
target values. This can be done once calibration is complete.
REFERENCES
American Journal of Pediatric Hematology/Oncology, The. 12(1): 95 - 104, 1990.
Henry, John Bernard, M.D., Clinical Diagnosis and Management by Laboratory Methods, 19th Ed., W.B.
Saunders Company, 1996, p 725.
NCCLS Document H21-A1, Vol. 18, #20, December 1998. Collection, Transport, and Processing of Blood
Specimens for Coagulation Testing and Performance of Coagulation Assays; Approved Guideline – 3rd
Ed.
NCCLS Document H30-T, Vol. 11, #7, 1991. Procedure for the Determination of Fibrinogen in Plasma.
Operator’s Manual
IL ACLAdvance, P/N 700000. Rev. 02, August 2000.
IL ACL Futura System, P/N 18902411, Rev. 7, November 1998.
Package Inserts
HemosILTMFibrinogen-C (Cat. #0008469110-Beckman). 301207 R7 5/2004.
HemosILTM Routine Control Level 1 UNASSAYED (Cat. #0020005600-Beckman) 303370 R0 10/2004.
HemosILTM Low Fibrinogen Control (Cat. #0020004200-Beckman) 300562 R10 04/2006.