Cholesterol Gen.2

Catalog Number: 05168538190

SYSTEM INFORMATION

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
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 1‑Point
Reaction time / Assay points 10 / 38
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 4 µL

Calibration

CALIBRATION

 Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear

CALIBRATION MODE

CALIBRATION FREQUENCY

BLANK CALIBRATION

2‑POINT CALIBRATION

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

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:

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 701 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).