Creatine Kinase

Catalog Number: 05168546190

SYSTEM INFORMATION

CK: ACN 8057

INTENDED USE

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

STORAGE AND STABILITY

CK
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
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 / 27-38
Wavelength (sub/main) 546/340 nm
Reaction direction Increase
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R3 20 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2.8 µL
Decreased 2.8 µL 15 µL 150 µL
Increased 5.6 µL

Calibration

CALIBRATION

Traceability: This method has been standardized against the IFCC Method for Creatine Kinase.​8

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

7-2000 U/L (0.117-33.4 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

RESULTS FOR INTERMEDIATE PRECISION WERE OBTAINED ON THE ROCHE/HITACHI 917 ANALYZER.

METHOD COMPARISON

Creatine kinase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the same 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.