Lactate Dehydrogenase acc. to IFCC ver.2

Catalog Number: 03004732122

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

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: 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 / 20‑33
Wavelength (sub/main) 700/340 nm
Reaction direction Increase
Units U/L (µkat/L)
Reagent pipetting Diluent (H2O)
R1 100 µL
R2 20 µL
Sample volumes LDHI2 Sample Sample dilution
Sample Diluent (H2O)
Normal 2.8 µL
Decreased 1.1 µL
Increased 2.8 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 14 µL 20 µL 80 µL

 

CALIBRATION

Traceability: This method has been standardized against the original IFCC6 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

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.

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

LDH 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,