γ-Glutamyltransferase ver.2 Standardized against IFCC / Szasz

Catalog Number: 03002721122

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of γ‑glutamyltransferase (GGT) in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 GGT‑2
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 / 13‑42
Wavelength (sub/main) 700/415 nm
Reaction direction Increase
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 25 µL 75 µL
R2 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 3 µL 15 µL 150 µL
Increased 3 µL
 cobas c 501 test definition
Assay type Rate A
Reaction time / Assay points 10 / 19‑56
Wavelength (sub/main) 700/415 nm
Reaction direction Increase
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 25 µL 75 µL
R2 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 3 µL 15 µL 150 µL
Increased 3 µL
 cobas c 502 test definition
Assay type Rate A
Reaction time / Assay points 10 / 19‑56
Wavelength (sub/main) 700/415 nm
Reaction direction Increase
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 25 µL 75 µL
R2 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 3 µL
Decreased 3 µL 15 µL 150 µL
Increased 6 µL

Calibration

COBAS C TEST DEFINITION

COBAS C 502 TEST DEFINITION

CALIBRATION

Traceability: This method has been standardized against the original IFCC formulation (2002)5 and against the GGT method published by Persijn and van der Slik (1976)4, respectively.

 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

LIMITS AND RANGES

Measuring range

MEASURING RANGE

3‑1200 U/L (0.05‑20.0 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, 21 days).

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, 21 DAYS).

INTERMEDIATE PRECISION

METHOD COMPARISON

γ‑glutamyltransferase 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.