HDL-Cholesterol Gen.4

Catalog Number: 07528566190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

In vitro diagnostic test for the quantitative determination of the HDL‑cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

HDLC4
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 2‑Point End
Reaction time / Assay points 10/6‑33
Wavelength (sub/main) 700/600 nm
Reaction direction Increase
Units mmol/L (mg/dL)
Reagent pipetting Diluent (H2O)
R1 120 µL
R2 40 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2.4 µL
Decreased 12.5 µL 15 µL 135 µL
Increased 2.4 µL

 

CALIBRATION

 

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

2‑POINT CALIBRATION

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

QUALITY CONTROL MATERIALS ARE INTENDED FOR USE ONLY AS MONITORS OF ACCURACY AND PRECISION.

Repeatability and intermediate precision were determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements (4 aliquots per run, 1 run per day, 21 days). The following results were obtained:

LIMITS AND RANGES

Measuring range

MEASURING RANGE

3.09‑150 mg/dL (0.08‑3.88 mmol/L)

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection and Limit of Quantitation

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

Repeatability and intermediate precision were determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP5 requirements (4 aliquots per run, 1 run per day, 21 days). The following results were obtained:

REPEATABILITY AND INTERMEDIATE PRECISION WERE DETERMINED USING HUMAN SAMPLES AND CONTROLS IN ACCORDANCE WITH THE CLSI (CLINICAL AND LABORATORY STANDARDS INSTITUTE) EP5 REQUIREMENTS (4 ALIQUOTS PER RUN, 1 RUN PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

HDL‑cholesterol values for human serum samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the HDL Ultra Cholesterol 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,