Catalog Number: 03038866322
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems.
|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|
|cobas c 311 test definition|
|Assay type||2-Point End|
|Reaction time / Assay points||10 / 6-31|
|Wavelength (sub/main)||700/600 nm|
|Units||mmol/L (mg/dL, g/L)|
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 frequency||2-point calibration• after reagent lot change• as required following quality control procedures|
0.10-14.2 mmol/L (3.86-548 mg/dL)
Lower detection limit of the test
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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:
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).