LDL-Cholesterol plus 2nd generation

Catalog Number: 03038866322

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

LDL_C
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 2-Point End
Reaction time / Assay points 10 / 6-31
Wavelength (sub/main) 700/600 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)

CALIBRATION

Traceability: This method has been standardized against the beta quantification method as defined in the recommendations in the LDL Cholesterol Method Certification Protocol for Manufacturers.​13

Calibrators S1: H2OS2: C.f.a.s. Lipids
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

0.10-14.2 mmol/L (3.86-548 mg/dL)

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

LDL cholesterol values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared to 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.