Cholesterol Gen.2

Catalog Number: 03039773190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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

STORAGE AND STABILITY

CHOL2
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
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 1‑Point
Reaction time / Assay points 10 / 57
Wavelength (sub/main) 700/505 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)
Reagent pipetting Diluent (H2O)
R1 47 µL 93 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 2 µL 15 µL 135 µL
Increased 2 µL
 cobas c 501 test definition
Assay type 1‑Point
Reaction time / Assay points 10 / 70
Wavelength (sub/main) 700/505 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)
Reagent pipetting Diluent (H2O)
R1 47 µL 93 µL
Sample volumes Sample Sample dilution
Sample Diluent (NaCl)
Normal 2 µL
Decreased 2 µL 15 µL 135 µL
Increased 2 µL
cobas c 502 test definition
Assay type 1‑Point
Reaction time / Assay points 10 / 70
Wavelength (sub/main) 700/505 nm
Reaction direction Increase
Units mmol/L (mg/dL, g/L)
Reagent pipetting Diluent (H2O)
R1 47 µL 93 µL

CALIBRATION

Traceability: This method has been standardized according to Abell/Kendall12 and also by isotope dilution/mass spectrometry.16

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

2‑POINT CALIBRATION• AFTER REAGENT LOT CHANGE• AS REQUIRED FOLLOWING QUALITY CONTROL PROCEDURES

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.1‑20.7 mmol/L (3.86‑800 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:

METHOD COMPARISON

Cholesterol 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, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.