Creatine Kinase-MB

Catalog Number: 04525299190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro test for the quantitative determination of the catalytic activity of creatine kinase MB subunit(CK-MB) in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

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

APPLICATION FOR SERUM AND PLASMA

cobas c 311 test definition
Assay type Rate A
Reaction time / Assay points 10/37-56
Wavelength (sub/main) 546/340 nm
Reaction direction Increase
Units U/L (µkat/L)

CALIBRATION

Traceability: This method has been standardized against the original IFCC formulation​3 with addition of antibodies using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

Calibrators S1: H2OS2: C.f.a.s. CK-MB
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

3-500 U/L (0.05-8.35 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). 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, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Creatine kinase-MB 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).