Catalog Number: 05795419190
3BILT: ACN 82973SBIL: ACN 8296 (STAT, reaction time: 4)
In vitro test for the quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
| 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 |
| 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
cobas c 701/702 test definition
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 | |
Measuring range
3BILT, ACN 82970.15‑32.2 mg/dL (2.5‑550 µmol/L)
Limit of Blank, Limit of Detection and Limit of Quantitation
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Repeatability was determined using human samples and controls in an internal protocol (n = 21, 1 run). Intermediate precision was 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:
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 corresponding reagent on a cobas c 701 analyzer (x).Sample size (n) = 61