Bilirubin Total Gen.3

Catalog Number: 05795397190

SYSTEM INFORMATION

For cobas c 311/501 analyzers:3BILT: ACN 2973SBIL: ACN 296 (STAT, reaction time: 4)

INTENDED USE

In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

STORAGE AND STABILITY

 BILT3
Shelf life at 2‑8 °C: See expiration date on cobas c pack label.
On-board in use and refrigerated on the analyzer: 6 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

CALIBRATION

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

 Calibrators S1: H2OS2: C.f.a.s.
Calibration mode Linear
Calibration frequency 2‑point calibration
-- after reagent lot changeas 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.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.15‑35.1 mg/dL (2.5‑600 µmol/L)

LOWER LIMITS OF MEASUREMENT

Limit of Blank, Limit of Detection and Limit of Quantitation

SPECIFIC PERFORMANCE DATA

Representative performance data on the cobas c 501 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 (2 aliquots per run, 2 runs 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 (2 ALIQUOTS PER RUN, 2 RUNS PER DAY, 21 DAYS). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

Total bilirubin values for human serum samples of adults obtained on a cobas c 501 analyzer (y) using the Roche Bilirubin Total Gen.3 reagent were compared with those determined using the Roche Bilirubin Total Special reagent on the same analyzer (x).Sample size (n) = 131

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.