Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation

Catalog Number: 04467388190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

 ALTLP
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On‑board in use and refrigerated on the analyzer: 12 weeks
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: 12 weeks

Specimen collection and preparation

APPLICATION FOR SERUM AND PLASMA

 cobas c 311 test definition
Assay type Rate A
Reaction time / Assay points 10 / 29‑57
Wavelength (sub/main) 700/340 nm
Reaction direction Decrease
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 59 µL 32 µL
R2 20 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 9 µL
 cobas c 501 test definition
Assay type Rate A
Reaction time / Assay points 10 / 44‑70
Wavelength (sub/main) 700/340 nm
Reaction direction Decrease
Units U/L (µkat/L)

CALIBRATION

 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

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

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:

INTERMEDIATE PRECISION

METHOD COMPARISON

ALT values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x).

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.