Aspartate Aminotransferase acc. to IFCC with pyridoxal phosphate activation

Catalog Number: 05531446190

SYSTEM INFORMATION

INTENDED USE

In vitro test for the quantitative determination of aspartate aminotransferase (AST) with pyridoxal phosphate activation in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 ASTPM
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 2 weeks
On‑board on the Reagent Manager: 0 hours
Diluent NaCl 9 %
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 4 weeks
On‑board on the Reagent Manager: 24 hours

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

 cobas c 701/702 test definition
Assay type Rate A
Reaction time / Assay points 10 / 29‑38
Wavelength (sub/main) 700/340 nm
Reaction direction Decrease
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 60 µL 51  µL
R3 20 µL 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 9 µL
Decreased 9 µL 15 µL 135 µL
Increased 18 µL
 

Calibration

COBAS CTEST DEFINITION

CALIBRATION

Traceability: This method has been standardized against the original IFCC formulation using calibrated pipettes together with a manual photometer providing absolute values and the substrate‑specific absorptivity, ε.7

Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2‑point calibration- after reagent lot change- as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

2‑POINT CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

5‑700 U/L (0.08‑11.7 µkat/L)

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the 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 (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 20 days). The following results were obtained:

PRECISION WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL WITH REPEATABILITY (N = 21) AND INTERMEDIATE PRECISION (3 ALIQUOTS PER RUN, 1 RUN PER DAY, 20 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

METHOD COMPARISON

AST values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).