ICT (Na , K , Cl¯) Sample Diluent

Transcription

ICT (Na+, K+, Cl¯) Sample Diluent
2P32-11 and 2P32-50
304465/R1
ICT (Na+, K+, Cl¯)
Sample Diluent
This package insert contains information to run the ICT Sodium, Potassium, and Chloride assays on the
ARCHITECT c Systems.
NOTE: This package insert must be read carefully prior to product use. Package insert instructions must be
followed accordingly. Reliability of assay results cannot be guaranteed if there are any deviations from the
instructions in this package insert.
Customer Support
United States:
Canada:
International:
1-877-4ABBOTT
1-800-387-8378 (English speaking customers)
1-800-465-2675 (French speaking customers)
Call your local Abbott representative
Symbols in Product Labeling
Calibrator High
Reagent 1
Calibrator Low
Catalog number/List number
Concentration
Serial number
Contents of kit
Urine Calibrator High
Authorized Representative in the
European Community
Urine Calibrator Low
ICT Cleaning Fluid
Manufacturer
ICT Lyophilized Cleaning Solution
Consult instructions for use
Ingredients
Temperature limitation
In vitro diagnostic medical device
Use by/Expiration date
Batch code/Lot number
October 2009
©2009 Abbott Laboratories
1
NAME
REAGENT HANDLING AND STORAGE (Continued)
ICT (Na+, K+, Cl¯) Sample Diluent
Indications of Deterioration
The ARCHITECT c Systems ICT (Integrated Chip Technology) is used
for the quantitation of sodium, potassium, and chloride in human serum,
plasma, or urine.
Instability or deterioration should be suspected if there are visible
signs of leakage, extreme turbidity, microbial growth, or if ICT Module
calibration does not meet the appropriate package insert and/or
ARCHITECT System Operations Manual criteria. Acetic acid odor from
the diluent is normal.
SUMMARY AND EXPLANATION OF TEST
WARNINGS AND PRECAUTIONS
Sodium is the major cation of extracellular fluid; it plays an essential
role in the normal distribution of water and in the maintenance of
osmotic pressure in extracellular fluid compartments. Decreased levels
of sodium may be caused by an excessive use of diuretics, prolonged
vomiting, a decrease in the intake of sodium in the diet, and metabolic
acidosis. Increased levels of sodium may be found in Cushing’s
syndrome, severe dehydration, or in high levels of salt intake without an
adequate supply of water.1
Potassium is the major intracellular cation. The concentration
of potassium in the erythrocytes is approximately 23 times the
concentration in plasma. For this reason, only unhemolyzed samples
must be used. Decreased levels of extracellular potassium are
characterized by weakness in the muscles, irritability, paralysis,
accelerated heartbeat, and eventually cardiac arrest, and may be
caused by a poor intake of potassium in the diet, by a redistribution of
extracellular potassium, and by an increased loss of body fluids rich
in potassium.1 Abnormally elevated levels of extracellular potassium
produce mental confusion, general weakness, numbness, flaccid
paralysis in the extremities, a slowed heart rate, and eventually collapse
of the peripheral vascular system and cardiac arrest. Causes of
increased potassium levels may be linked to inappropriate intravenous
therapy, dehydration, shock, diabetic ketoacidosis, and severe burns.1
Chloride is the major extracellular anion. The majority of ingested
chloride is absorbed, and the excess is excreted along with other
ions into the urine. Low levels of chloride are observed in the case
of prolonged vomiting accompanied by the loss of hydrochloric acid
(HCl), in some cases of metabolic acidosis in which there is an
increased accumulation of organic anions, in critical cases of Addison’s
disease, and in kidney disease resulting in loss of salt. Elevated
levels of chloride are observed in metabolic acidosis associated with
prolonged diarrhea and with loss of sodium bicarbonate (NaHCO3),
and in the case of renal tubular diseases in which there is a decreased
excretion of hydrogen ion (H+), which causes in turn a decrease in
the reabsorption of bicarbonate ion (HCO3–). Elevated levels of serum
chloride are also implicated in certain cases of hyperparathyroidism.1
Precautions for Users
INTENDED USE
1.
2.
3.
4.
SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum, plasma, and urine are acceptable specimens.
• Serum: Use serum collected by standard venipuncture techniques
into glass or plastic tubes with or without gel barriers. Ensure
complete clot formation has taken place prior to centrifugation.
When processing samples, separate serum from blood cells or
gel according to the specimen collection tube manufacturer’s
instructions.
Some specimens, especially those from patients receiving
anticoagulant or thrombolytic therapy, may take longer to complete
their clotting processes. Fibrin clots may subsequently form in these
sera and the clots could cause erroneous test results.
For Potassium, hemolyzed specimens must not be used.
• Plasma: Use plasma collected by standard venipuncture techniques
into glass or plastic tubes. Acceptable anticoagulants are lithium
heparin (with or without gel barrier) and sodium heparin (full draw).
Ensure centrifugation is adequate to remove platelets. When
processing samples, separate plasma from blood cells or gel
according to the specimen collection tube manufacturer’s
instructions.
NOTE: Multiple myeloma and lipid samples are known to give low
results on diluted ISE systems due to the high level of proteins/lipids
present in the sample.6,7
• Urine: Collect random or 24 hour urine specimens without the
addition of preservatives.1
The sample volume for the ICT assays is 15 μL. This volume is mixed
with 69 μL of ICT Sample Diluent and 276 μL of system water. For total
sample volume requirements, refer to Section 5 of the ARCHITECT
System Operations Manual.
PRINCIPLES OF PROCEDURE
Ion-selective electrodes for sodium, potassium, and chloride utilize
membranes selective to each of these ions. An electrical potential
(voltage) is developed across the membranes between the reference
and measuring electrodes in accordance with the Nernst equation. The
voltage is compared to previously determined calibrator voltages and
converted into ion concentration.
Methodology: Ion-selective electrode diluted (Indirect)
Specimen Storage
Serum and Plasma
REAGENTS
Temperature
Reagent Kit
2P32 ICT Sample Diluent (ICTD5) is supplied as a liquid,
ready-to-use single reagent kit which contains either:
2P32-11
10 x 93 mL
•
Estimated samples per kit: 12,000*
2P32-50
10 x 54 mL
•
Estimated samples per kit: 7,000*
20 to 25°C
2 to 8°C
-20°C
Urine
Temperature
*Calculation is based on the minimum diluent fill volume per kit. One
sample can generate one to three test results.
Reactive Ingredients
Buffer
For in vitro diagnostic use.
Do not use components beyond the expiration date.
Do not mix materials from different kit lot numbers.
CAUTION: This product requires the handling of human specimens.
It is recommended that all human sourced materials be considered
potentially infectious and be handled in accordance with the OSHA
Standard on Bloodborne Pathogens.2 Biosafety Level 23 or other
appropriate biosafety practices4,5 should be used for materials that
contain or are suspected of containing infectious agents.
20 to 25°C
2 to 8°C
-20°C
Concentration
N/A
Temperature
REAGENT HANDLING AND STORAGE
20 to 25°C
2 to 8°C
-20°C
Reagent Handling
Remove air bubbles, if present in the diluent cartridge, with a new
applicator stick. Alternatively, allow the diluent to sit at the appropriate
storage temperature to allow the bubbles to dissipate. To minimize
volume depletion, do not use a transfer pipette to remove the bubbles.
CAUTION: Bubbles may interfere with proper detection of diluent level in
the cartridge, causing insufficient diluent aspiration which could impact
results.
Sodium
2 weeks
2 weeks
1 year
Maximum Storage
Potassium
Chloride
1 week
7 days
1 week
7 days
1 year
> 1 year
Maximum Storage
Sodium
Potassium
45 days
45 days
45 days
2 months
1 year
1 year
Bibliographic
Reference
8
8, 9
8
Maximum Storage
Chloride
7 days
7 days
7 days
Bibliographic
Reference
10
9, 10
9
Bibliographic
Reference
8
8, 9
8
Guder et al. 8 suggest storage of frozen specimens at -20°C for no longer
than the time intervals cited above. However, limitations of laboratory
equipment make it necessary in practice for clinical laboratories to
establish a range around -20°C for specimen storage. This temperature
range may be established from either the freezer manufacturer’s
specifications or your laboratory standard operating procedure(s) for
specimen storage.
NOTE: Stored specimens must be inspected for particulates. If present,
mix and centrifuge the specimen to remove particulates prior to testing.
Reagent Storage
Unopened diluent is stable until the expiration date when stored
at 15 to 30°C.
Diluent stability is 30 days if it is uncapped and onboard.
2
PROCEDURE
EXPECTED VALUES
Materials Provided
Reference Range
•
A study was conducted using 145 serum samples and 155 plasma
samples from 84 female and 72 male volunteers. Data were analyzed as
described by Clinical and Laboratory Standards Institute (CLSI) protocol
NCCLS C28-A2.11 A non-parametric method was used to calculate
the 95% reference interval. From this study 95% of sodium results fell
within 137 to 144 mmol/L with samples ranging from 133 to 145 mmol/L;
95% of potassium results fell within 3.5 to 5.0 mmol/L with samples
ranging from 3.1 to 5.4 mmol/L; and 95% of chloride results fell within
101 to 110 mmol/L with samples ranging from 93 to 113 mmol/L. From
this same study 95% of anion gap results fell within 5 to 13 mEq/L with
sample results ranging from 3 to 14 mEq/L. Anion gap values were
calculated as ([Na+] - ([CO2] + [Cl-])).
2P32 ICT Sample Diluent (ICTD5) Kit
Materials Required but not Provided
•
•
•
•
•
•
•
9D28 ICT Module
1E49 ICT Reference Solution 2 x 2 L
1E50 ICT Cleaning Fluid
1 x 150 mL
10 x 12 mL
1E46 ICT Serum Calibrator
5 x 10 mL
5 x 10 mL
1E47 ICT Urine Calibrator
5 x 10 mL
5 x 10 mL
Control Material
Disposable Pipette
Serum/Plasma12
Range (mmol/L)
Sodium
Premature, Cord
Premature, 48 hours
Newborn, Cord
Newborn
Infant
Child
Thereafter
Potassium
Premature, Cord
Premature, 48 hours
Newborn, Cord
Newborn
Infant
Child
Thereafter
Plasma, Male
Plasma, Female
Chloride
Cord
Newborn, 0 to 30 days
Thereafter
Assay Procedure
For a detailed description of how to run an assay, refer to Section 5 of
the ARCHITECT System Operations Manual.
CALIBRATION
Calibration is stable up to 24 hours and calibration is required with each
change in diluent lot number. The laboratory may choose any calibration
interval up to 24 hours. The use of a particular calibration time interval is
dependent on individual laboratory policy or preference. Verify calibration
curve with at least two levels of controls according to the established
quality control requirements for your laboratory. If control results fall
outside acceptable ranges, recalibration may be necessary.
For a detailed description of how to calibrate an assay, refer to Section 6
of the ARCHITECT System Operations Manual.
For information on calibrator standardization, refer to
1E46 ICT
Serum Calibrator and
1E47 ICT Urine Calibrator package inserts.
QUALITY CONTROL
The following is the recommendation of Abbott Laboratories for quality
control. As appropriate, refer to your laboratory standard operating
procedure(s) and/or quality assurance plan for additional quality control
requirements and potential corrective actions.
• Two levels of controls (normal and abnormal) are to be run every
8 hours and following calibration.
• If more frequent control monitoring is required, follow the established
quality control procedures for your laboratory.
• If quality control results do not meet the acceptance criteria
defined by your laboratory, patient values may be suspect. Follow
the established quality control procedures for your laboratory.
Recalibration may be necessary.
• Review control results and acceptance criteria following a change of
ICT Sample Diluent, ICT Reference Solution, or calibrator lot.
LIMITATIONS OF THE PROCEDURE
For Sodium, Potassium, and Chloride, results expressed in mmol/L are
equivalent to mEq/L; results expressed in mmol/day are equivalent to
mEq/day.
It is recommended that each laboratory determine its own reference
range based upon its particular locale and population characteristics.
Refer to the SPECIMEN COLLECTION AND HANDLING and SPECIFIC
PERFORMANCE CHARACTERISTICS sections of this package insert.
Cross contamination testing for the ICTD5 Sample Diluent
2P32
was performed on an ARCHITECT c System.
24 Hour Urinary Excretion: Sodium, Postassium, and Chloride
To convert results from mmol/L to mmol/day (24 hour urinary excretion)
Where:
V = 24 hour urine volume (mL)
c = analyte concentration (mmol/L)
24 hour excretion = [(V × c) ÷ 1000] mmol/day
ARCHITECT c Systems Assays affected by ICTD5 Sample Diluent
Configure ICTD5 Sample Diluent SmartWash entries in the following
assay files on the ARCHITECT c System.
Mg
Mg-U
7D70
7D70
R1 Only
R1 Only
96 to 104
98 to 113
98 to 107
Range mmol/day
Sodium
Male
6 to 10 years
41 to 115
10 to 14 years
63 to 177
Adult
40 to 220
Female
6 to 10 years
20 to 69
10 to 14 years
48 to 168
Adult
40 to 220
Full-term, 7 to 14 day old neonates have sodium
clearance of about 20% of adult values.
Potassium
General
25 to 125
Varies with diet.
Chloride
Infant
2 to 10
Child
15 to 40
Thereafter
110 to 250
Varies greatly with Cl intake.
Refer to Appendix C of the ARCHITECT System Operations Manual for
information on results calculations.
Representative performance data are given in the EXPECTED VALUES
and SPECIFIC PERFORMANCE CHARACTERISTICS sections of this
package insert. Results obtained in individual laboratories may vary.
COMPONENT
5.0 to 10.2
3.0 to 6.0
5.6 to 12.0
3.7 to 5.9
4.1 to 5.3
3.4 to 4.7
3.5 to 5.1
3.5 to 4.5
3.4 to 4.4
Urine12
RESULTS
Configure
116 to 140
128 to 148
126 to 166
133 to 146
139 to 146
138 to 145
136 to 145
REAGENT /
WASH
VOL REP
ASSAY
ICTD5 0.5% Acid Wash 345 1
ICTD5 0.5% Acid Wash 345 1
3
SPECIFIC PERFORMANCE CHARACTERISTICS
Linearity
(Continued)
Precision
Sodium serum is linear up to 200 mmol/L. Sodium urine is linear up to
400 mmol/L.
Potassium serum is linear up to 10 mmol/L. Potassium urine is linear up
to 300 mmol/L.
Chloride serum is linear up to 150 mmol/L. Chloride urine is linear up to
300 mmol/L.
Linearity was verified using CLSI protocol NCCLS EP6-P.13
Serum
The imprecision of the ICT assays for serum samples are as follows:
Sodium ≤ 1.5%, Potassium ≤ 2.7%, Chloride ≤ 2.0%. Representative data
from studies using CLSI protocol NCCLS EP5-A16 are summarized below.
Control
N
Mean (mmol/L)
Reportable Range
Serum/Plasma
(mmol/L)
100 to 200
1.0 to 10.0
50 to 150
Sodium
Potassium
Chloride
Urine
(mmol/L)
20 to 400
1.0 to 300.0
20 to 300
SD
%CV
SD
Between Run
%CV
SD
Between Day
%CV
SD
Total
%CV
Within Run
Interfering Substances
Interference studies were conducted using CLSI protocol NCCLS EP7-P.14
Interference effects were assessed by Dose Response and Paired
Difference methods, at the medical decision level of the analyte.
Bilirubin solutions at the concentrations listed below were prepared by
addition of a bilirubin stock to human serum pools. Hemoglobin solutions at
the concentrations listed below were prepared by addition of hemolysate to
human serum pools. Intralipid solutions at the concentrations listed below
were prepared by addition of Intralipid to human serum pools.
Urine
The imprecision of the ICT assays for urine samples are as follows:
Sodium ≤ 3.0%, Potassium ≤ 3%, Chloride ≤ 1.8%. Representative data
from studies using CLSI protocol NCCLS EP10-A17 are summarized below.
Control
N
Mean (mmol/L)
Sodium
Interfering
Substance
Bilirubin
Hemoglobin
Intralipid
Interferent Concentration
30 mg/dL
60 mg/dL
1,000 mg/dL
2,000 mg/dL
1,000 mg/dL
2,000 mg/dL
(513 μmol/L)
(1,026 μmol/L)
(10.0 g/L)
(20.0 g/L)
(10.0 g/L)
(20.0 g/L)
N
4
4
4
4
4
4
Target
Observed
(mmol/L) (% of Target)
142.5
98.5
142.5
97.4
108.3
102.1
108.3
104.5
117.8
100.8
117.8
100.7
SD
%CV
SD
Between Run
%CV
SD
Between Day
%CV
SD
Total
%CV
Within Run
For the Sodium urine application, protein up to 50 mg/dL, glucose
up to 1,000 mg/dL, ascorbate up to 200 mg/dL, acetic acid up to
6.25 mL/dL, boric acid up to 250 mg/dL, hydrochloric acid up to
2.5 mL/dL, and nitric acid up to 5.0 mL/dL demonstrated less than
10% interference. Sodium carbonate at 1.25 g/dL and sodium fluoride at
400 mg/dL demonstrated greater than 10% interference. Sodium oxalate
at 60 mg/dL demonstrated less than 10% interference at a sodium
concentration of 162 mmol/L. At a sodium concentration of 74 mmol/L,
sodium oxalate demonstrated greater than 10% interference.
Potassium
Interfering
Substance
Bilirubin
Hemoglobin
Intralipid
30 mg/dL
60 mg/dL
125 mg/dL
250 mg/dL
1,000 mg/dL
2,000 mg/dL
(513 μmol/L)
(1,026 μmol/L)
(1.25 g/L)
(2.50 g/L)
(10.0 g/L)
(20.0 g/L)
N
4
4
4
4
4
4
Target
Observed
3.3
98.8
3.3
97.2
4.7
108.9
4.7
117.9
3.7
99.3
3.7
100.7
For the Potassium urine application, protein up to 50 mg/dL, glucose
up to 1,000 mg/dL, ascorbate up to 200 mg/dL, acetic acid up to
6.25 mL/dL, boric acid up to 250 mg/dL, hydrochloric acid up to
2.5 mL/dL, nitric acid up to 5.0 mL/dL, sodium carbonate up to
1.25 g/dL, sodium fluoride up to 400 mg/dL, and sodium oxalate
up to 60 mg/dL demonstrated less than 10% interference.
Chloride
Interfering
Substance
Bilirubin
Hemoglobin
Intralipid
30 mg/dL
60 mg/dL
1,000 mg/dL
2,000 mg/dL
1,000 mg/dL
2,000 mg/dL
(513 μmol/L)
(1,026 μmol/L)
(10.0 g/L)
(20.0 g/L)
(10.0 g/L)
(20.0 g/L)
N
4
4
4
4
4
4
Sodium
Potassium
Chloride
Level 1 Level 2 Level 1 Level 2 Level 1 Level 2
80
80
80
80
80
80
153.4 131.1
4.2
6.4
98.6
88.6
1.95
0.57
0.05
0.03
1.23
0.37
1.3
0.4
1.2
0.4
1.3
0.4
0.00
0.54
0.00
0.03
0.00
0.31
0.0
0.4
0.0
0.5
0.0
0.4
0.50
0.46
0.02
0.04
0.33
0.37
0.3
0.4
0.6
0.7
0.3
0.4
2.01
0.91
0.06
0.06
1.27
0.61
1.3
0.7
1.4
1.0
1.3
0.7
Target
Observed
107.9
99.9
107.9
99.6
92.4
106.2
92.4
112.1
100.9
100.1
100.9
100.1
For the Chloride urine application, protein up to 50 mg/dL, glucose up to
1,000 mg/dL, ascorbate up to 200 mg/dL, acetic acid up to 6.25 mL/dL,
boric acid up to 250 mg/dL, nitric acid up to 5.0 mL/dL, sodium carbonate
up to 1.25 g/dL, sodium fluoride up to 400 mg/dL, and sodium oxalate up
to 60 mg/dL demonstrated less than 10% interference. Hydrochloric acid
at 2.5 mL/dL demonstrated greater than 10% interference.
Interferences from medications or endogenous substances may affect
results.15
4
Sodium
Potassium
Chloride
Level 1 Level 2 Level 1 Level 2 Level 1 Level 2
80
80
80
80
80
80
79.3 181.0 30.8
83.9
79.2 218.4
1.09
1.53
0.43
0.69
1.16
1.64
1.4
0.8
1.4
0.8
1.5
0.8
0.62
0.43
0.14
0.51
0.28
0.59
0.8
0.2
0.5
0.6
0.4
0.3
0.16
1.98
0.34
0.84
0.83
2.47
0.2
1.1
1.1
1.0
1.1
1.1
1.27
2.54
0.56
1.20
1.45
3.03
1.6
1.4
1.8
1.4
1.8
1.4
(Continued)
BIBLIOGRAPHY
1.
Method Comparison
Correlation studies were performed based on CLSI protocol
NCCLS EP9-A.18
Serum and urine results from the Sodium, Potassium, and Chloride
assays on the AEROSET System were compared with those from a
commercially available ion-selective electrode methodology.
Serum and urine results from the Sodium, Potassium, and Chloride
assays on an ARCHITECT c System were compared with the results on
the AEROSET System.
2.
3.
4.
5.
Sodium
Serum
N
Y - Intercept
Correlation Coefficient
Slope
Range (mmol/L)*
* AEROSET Range
Urine
N
Y - Intercept
Slope
Range (mmol/L)*
* AEROSET Range
AEROSET vs.
Comparative Method
57
-3.052
0.997
1.032
121.62 to 175.56
ARCHITECT
vs. AEROSET
66
9.897
0.975
0.924
120.81 to 179.94
AEROSET vs.
Comparative Method
46
0.492
0.999
0.972
20.39 to 390.20
ARCHITECT
vs. AEROSET
63
3.098
1.000
0.968
20.99 to 390.91
6.
7.
8.
9.
10.
11.
12.
Potassium
Serum
N
Y - Intercept
Slope
Range (mmol/L)*
* AEROSET Range
Urine
N
Y - Intercept
Slope
Range (mmol/L)*
* AEROSET Range
AEROSET vs.
Comparative Method
57
-0.035
0.999
1.022
2.34 to 9.70
ARCHITECT
vs. AEROSET
63
0.125
0.998
0.978
2.16 to 9.89
AEROSET vs.
Comparative Method
55
0.164
1.000
0.992
1.07 to 131.19
ARCHITECT
vs. AEROSET
68
-0.969
0.997
0.964
1.10 to 141.88
13.
14.
15.
16.
17.
18.
Chloride
Serum
N
Y - Intercept
Slope
Range (mmol/L)*
* AEROSET Range
Urine
N
Y - Intercept
Slope
Range (mmol/L)*
* AEROSET Range
AEROSET vs.
Comparative Method
58
-2.668
0.995
1.039
62.62 to 136.29
ARCHITECT
vs. AEROSET
66
2.036
0.997
0.971
61.27 to 139.75
AEROSET vs.
Comparative Method
40
0.842
0.996
0.991
21.66 to 240.62
ARCHITECT
vs. AEROSET
67
3.175
0.996
0.953
20.03 to 291.97
Tietz NW, Pruden EL, Siggaard-Anderson O. Electrolytes. In: Burtis
CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry, 2nd
ed. Philadelphia, PA: WB Saunders; 1994:1354–74.
US Department of Labor, Occupational Safety and Health
Administration. 29 CFR Part 1910.1030. Bloodborne Pathogens.
US Department of Health and Human Services. Biosafety in
Microbiological and Biomedical Laboratories, 5th ed. Washington,
DC: US Government Printing Office, January 2007.
World Health Organization. Laboratory Biosafety Manual, 3rd ed.
Geneva: World Health Organization, 2004.
Sewell DL, Bove KE, Callihan DR, et al. Protection of Laboratory
Workers from Occupationally Acquired Infections; Approved
Guideline—Third Edition (M29-A3). Wayne, PA: Clinical and
Laboratory Standards Institute, 2005.
Kaplan LA, Pesce AJ, Kazmierczak SC. Clinical Chemistry – Theory,
Analysis, and Correlation, 3rd ed. St Louis, MO: Mosby, 1996:461–3.
McPherson RA, Bidkorpeh EK, Castellani WJ, et al. Analysis of Body
Fluids in Clinical Chemistry; Approved Guideline (C49-A). Wayne, PA:
The National Committee for Clinical Laboratory Standards, 2007.
Guder WG, Narayanan S, Wisser H, et al. List of analytes—preanalytical
variables. Annex In: Samples: From the Patient to the Laboratory.
Darmstadt, Germany: GIT Verlag; 1996:Annex 10–1, 20–1, 40–1.
US Pharmacopeial Convention, Inc. General notices. In: US
Pharmacopeia National Formulary, 1995 ed (USP 23/NF 18).
Rockville, MD: The US Pharmacopeial Convention, Inc; 1994:11.
Pesce AJ, Kaplan LA, editors. Methods in Clinical Chemistry.
St Louis, MO: CV Mosby, 1987:75.
Sasse EA, Doumas BT, Miller WG, et al. How to Define and
Determine Reference Intervals in the Clinical Laboratory; Approved
Guideline—Second Edition (C28-A2). Wayne, PA: The National
Committee for Clinical Laboratory Standards, 2000.
Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
2nd ed. Philadelphia, PA: WB Saunders; 1994:2182, 2202–3, 2206.
Passey RB, Bee DE, Caffo A, et al. Evaluation of the Linearity
of Quantitative Analytical Methods; Proposed Guideline (EP6-P).
Villanova, PA: The National Committee for Clinical Laboratory
Standards, 1986.
Powers DM, Boyd JC, Glick MR, et al. Interference Testing in Clinical
Chemistry; Proposed Guideline (EP7-P). Villanova, PA: The National
Committee for Clinical Laboratory Standards, 1986.
Young DS. Effects of Drugs on Clinical Laboratory Tests, 4th ed.
Washington, DC: AACC Press, 1995:3-137–3-141, 3-476–3-486,
3-531–3-540.
Kennedy JW, Carey RN, Coolen RB, et al. Evaluation of Precision
Performance of Clinical Chemistry Devices; Approved Guideline
(EP5-A). Wayne, PA: The National Committee for Clinical Laboratory
Standards, 1999.
Krouwer JS, Castañeda-Méndez K, Dawson JM, et al. Preliminary
Evaluation of Quantitative Clinical Laboratory Methods; Approved
Guideline (EP10-A). Wayne, PA: The National Committee for Clinical
Laboratory Standards, 1998.
Kennedy JW, Carey RN, Coolen RB, et al. Method Comparison
and Bias Estimation Using Patient Samples; Approved Guideline
(EP9-A). Wayne, PA: The National Committee for Clinical Laboratory
Standards, 1995.
TRADEMARKS
The ARCHITECT c System family of instruments consists of c 4000,
c 8000, and c 16000 instruments.
AEROSET, ARCHITECT, c 4000, c 8000, c 16000, c System, and
SmartWash are trademarks of Abbott Laboratories in various
jurisdictions.
All other trademarks are property of their respective owners.
Abbott Laboratories
Abbott Park, IL 60064 USA
304465/R1
5
ABBOTT
Max-Planck-Ring 2
65205 Wiesbaden
Germany
+49-6122-580
ARCHITECT c SYSTEMS ASSAY PARAMETERS
Sodium Serum/Plasma—Conventional and SI Units
Sodium Urine—Conventional and SI Units
Configure assay parameters — General
о Calibration о SmartWash о Results
● General
Assay: Na-C
Number: 1101
Type:
о Interpretation
● General
Version: †
Potentiometric
Assay: Na-CU
Number: 1133
Type:
Reagent 1: ICTD5
Assay:
Configure assay parameters — Calibration
● Calibration о SmartWash о Results
о Interpretation
о General
Na-C
Assay:
Calibration options:
Configure assay parameters — SmartWash
о Calibration ● SmartWash о Results
Assay:
Na-C
COMPONENT
REAGENT / ASSAY
Cuvette
Trig
WASH
10% Detergent B
о Interpretation
Volume
345
о General о Calibration ● SmartWash о Results о Interpretation
Assay:
Na-CU
COMPONENT
REAGENT / ASSAY WASH
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Replicates
Configure assay parameters — Results
о Calibration
о SmartWash ● Results о Interpretation
Assay: Na-C
Dilution default range:
Low-Linearity:
High-Linearity:
Gender and age specific ranges:
GENDER
AGE (UNITS)
NORMAL
Either
0 – 130 (Y)
136 – 145
о General
Assay: Na-CU
Assay number: 1133
Result units: mmol/L
Low-Linearity: 20
High-Linearity: 400
GENDER
AGE (UNITS)
NORMAL
EXTREME
Assay number: 1101
100
200
EXTREME
Configure result units
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Interpretation
Full Interval: 24* (hours)
Slope limit (%): 45 – 120
Calibrator low: ICTU-Low
Low Concentration: 50.0000
Calibrator high: ICTU-High
High Concentration: 180.0000
Replicates: 3
Index options:
Index used: ● No
о Yes
Index concentration:
Index range:
о General
Na-CU
Calibrator low: ICT-Low
Calibrator high: ICT-High
Replicates: 3
Index options:
Index used: ● No
о Yes
Index range:
о General
о Interpretation
Version: †
Reagent 1: ICTD5
о General
Potentiometric
о Calibration
Na-C
†
mmol/L
0
[Range 0 – 4]
1.0000
0.0000
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
† Due to differences in instrument systems and unit configurations, version numbers may vary.
* Calibration interval can be edited up to 24 hours.
6
Na-CU
†
mmol/L
0
[Range 0 – 4]
1.0000
0.0000
Potassium Serum/Plasma—Conventional and SI Units
Potassium Urine—Conventional and SI Units
● General
Assay: K-C
Number: 1102
Type:
о Interpretation
● General
Version: †
Potentiometric
Assay: K-CU
Number: 1134
Type:
Reagent 1: ICTD5
Assay:
о Interpretation
о General
K-C
Assay:
Assay:
K-C
COMPONENT
REAGENT / ASSAY
Cuvette
Trig
WASH
10% Detergent B
о Interpretation
Volume
345
Assay:
K-CU
COMPONENT
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Replicates
о Calibration
Assay: K-C
Low-Linearity:
High-Linearity:
GENDER
AGE (UNITS)
NORMAL
Either
0 – 130 (Y)
3.5 – 5.1
о General
Assay: K-CU
Assay number: 1134
Low-Linearity: 1.0
High-Linearity: 300.0
GENDER
AGE (UNITS)
NORMAL
EXTREME
Assay number: 1102
1.0
10.0
EXTREME
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Interpretation
Replicates: 3
Index options:
Index used: ● No
о Yes
Index range:
о General
K-CU
Replicates: 3
Index options:
Index used: ● No
о Yes
Index range:
о General
о Interpretation
Version: †
Reagent 1: ICTD5
о General
Potentiometric
о Calibration
K-C
†
mmol/L
1
[Range 0 – 4]
1.0000
0.0000
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
7
K-CU
†
mmol/L
1
[Range 0 – 4]
1.0000
0.0000
Chloride Serum/Plasma—Conventional and SI Units
Chloride Urine—Conventional and SI Units
● General
Assay: Cl-C
Number: 1103
Type:
о Interpretation
● General
Version: †
Potentiometric
Assay: Cl-CU
Number: 1135
Type:
Reagent 1: ICTD5
Assay:
о Interpretation
о General
Cl-C
Assay:
Assay:
Cl-C
COMPONENT
REAGENT / ASSAY
Cuvette
Trig
WASH
10% Detergent B
о Interpretation
Volume
345
Assay:
Cl-CU
COMPONENT
Volume Replicates
Cuvette
Trig
10% Detergent B
345
Replicates
о Calibration
Assay: Cl-C
Low-Linearity:
High-Linearity:
GENDER
AGE (UNITS)
NORMAL
Either
0 – 130 (Y)
98 – 107
о General
Assay: Cl-CU
Assay number: 1135
Low-Linearity: 20
High-Linearity: 300
GENDER
AGE (UNITS)
NORMAL
EXTREME
Assay number: 1103
50
150
EXTREME
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
о Interpretation
Replicates: 3
Index options:
Index used: ● No
о Yes
Index range:
о General
Cl-CU
Replicates: 3
Index options:
Index used: ● No
о Yes
Index range:
о General
о Interpretation
Version: †
Reagent 1: ICTD5
о General
Potentiometric
о Calibration
Cl-C
†
mmol/L
0
[Range 0 – 4]
1.0000
0.0000
Assay:
Version:
Result units:
Decimal places:
Correlation factor:
Intercept:
8
Cl-CU
†
mmol/L
0
[Range 0 – 4]
1.0000
0.0000

ICT (Na , K , Cl¯) Sample Diluent

Transcription

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