Lactate Dehydrogenase acc. to IFCC ver.2

Catalog Number: 05169330190

SYSTEM INFORMATION

LDHI2: ACN 8080

INTENDED USE

In vitro test for the quantitative determination of lactate dehydrogenase in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

LDHI2, LDIP2
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: 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 / 29-38
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R3 20 µL
Sample volumes LDHI2 Sample Sample dilution
Sample Diluent (H2O)
Normal 2.8 µL
Decreased 1.5 µL
Increased 5.6 µL
Sample volumes LDIP2 Sample Sample dilution
Sample Diluent (NaCl)
Normal 14 µL 20 µL 80 µL
Decreased 5.6 µL 20 µL 80 µL
Increased 20 µL 20 µL 80 µL

Calibration

CALIBRATION

Traceability: This method has been standardized against the original IFCC​6 formulation using calibrated pipettes together with a manual photometer providing absolute values and the substrate-specific absorptivity, ε.

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

10-1000 U/L (0.17-16.7 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, 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

INTERMEDIATE PRECISION

METHOD COMPARISON

LDHI2

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.