HDL-Cholesterol plus 3rd generation

Catalog Number: 05168805190

SYSTEM INFORMATION

HDLC3: ACN 8435

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

HDLC3
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
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 2-Point End
Reaction time / Assay points 10/18-38
Wavelength (sub/main) 700/600 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)
Reagent pipetting Diluent (H2O)
R1 150 µL
R3 50 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2.5 µL
Decreased 12.5 µL 15 µL 135 µL
Increased 5.0 µL

CALIBRATION

Traceability: This method has been standardized against the designated CDC reference method (designated comparison method).​19 The standardization meets the requirements of the “HDL Cholesterol Method Evaluation Protocol for Manufacturers” of the US National Reference System for Cholesterol, CRMLN (Cholesterol Reference Method Laboratory Network), November 1994.​21

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

QUALITY CONTROL MATERIALS ARE INTENDED FOR USE ONLY AS MONITORS OF ACCURACY AND PRECISION. THE LABORATORY STANDARDIZATION PANEL (LSP) OF THE NATIONAL CHOLESTEROL EDUCATION PROGRAM IN THE UNITED STATES RECOMMENDS TWO LEVELS OF CONTROLS, ONE IN THE NORMAL RANGE (0.9-1.7 MMOL/L OR 35-65 MG/DL) AND ONE NEAR THE CONCENTRATION FOR DECISION MAKING (< 0.9 MMOL/L OR < 35 MG/DL).

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:

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.08-3.12 mmol/L (3-120 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

HDL-cholesterol values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 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,