Aspartate Aminotransferase

Catalog Number: 20764949322

SYSTEM INFORMATION

Test ASTL, test ID 0‑494

INTENDED USE

In vitro test for the quantitative determination of the catalytic activity of AST (EC 2.6.1.1; L‑aspartate: 2‑oxoglutarate aminotransferase) in human serum and plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

 Shelf life at 2‑8 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10‑15 °C 12 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 12 weeks
 

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

COBAS INTEGRA 400 plus test definition

COBAS INTEGRA 400 PLUS TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Kinsearch
Reaction mode R1-S-SR
Reaction direction Decrease
Wavelength A/B 340/378 nm
Calc. first/last 39/64
Unit U/L

PIPETTING PARAMETERS

  Diluent (H2O)
R1 40 µL 29 µL
Sample 11 µL 26 µL
SR 17 µL 9 µL
Total volume 132 µL

COBAS INTEGRA 800 test definition

COBAS INTEGRA 800 TEST DEFINITION

 Measuring mode Absorbance
Abs. calculation mode Kinsearch
Reaction mode R1-S-SR
Reaction direction Decrease
Wavelength A/B 340/378 nm
Calc. first/last 54/97
Unit U/L

 Pipetting parameters

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Calibrator Calibrator f.a.s.Use deionized water as zero calibrator.
Calibration mode Linear regression
Calibration replicate Duplicate recommended
Calibration interval Each lot and as required following quality control procedures

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

2‑700 U/L (0.03‑11.7 µkat/L)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test:2 U/L (0.03 µkat/L)

SPECIFIC PERFORMANCE DATA

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Precision was determined using human samples and controls in an internal protocol with repeatability and intermediate precision (2 aliquots per run, 2 runs per day, 20 days). The following results were obtained.

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY AND INTERMEDIATE PRECISION (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED.

CV INTERMEDIATE PRECISION

METHOD COMPARISON

AST values for human serum and plasma samples obtained on a COBAS INTEGRA 700 analyzer using the COBAS INTEGRA Aspartate Aminotransferase reagent ASTL (y) were compared with those determined using commercially available reagents for AST on a COBAS INTEGRA analyzer (x) and on an alternative clinical chemistry system (x). Samples were measured in duplicate. Sample size (n) represents all replicates.

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.