Catalog Number: 05599261190
For cobas c 311/501 analyzers:
In vitro test for the quantitative determination of albumin in human serum and plasma on Roche/Hitachi cobas c systems.
| ALB BCP | |
| Shelf life at 15‑25 °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
| cobas c 311 test definition | |||
| Assay type | 2‑Point End | ||
| Reaction time / Assay points | 10 / 6‑26 | ||
| Wavelength (sub/main) | 700/600 nm | ||
| Reaction direction | Increase | ||
| Units | g/L (µmol/L, g/dL) | ||
| Reagent pipetting | Diluent (H2O) | ||
| R1 | 115 µL | – | |
| R2 | 70 µL | – | |
| Sample volumes | Sample | Sample dilution | |
| Sample | Diluent (NaCl) | ||
| Normal | 2 µL | – | – |
| Decreased | 4 µL | 15 µL | 135 µL |
| Increased | 2 µL | – | – |
| cobas c 501 test definition | |||
| Assay type | 2‑Point End | ||
| Reaction time / Assay points | 10 / 10‑28 | ||
| Wavelength (sub/main) | 700/600 nm | ||
| Reaction direction | Increase | ||
| Units | g/L (µmol/L, g/dL) | ||
| Reagent pipetting | Diluent (H2O) | ||
| R1 | 115 µL | – | |
| R2 | 70 µL | – | |
| Sample volumes | Sample | Sample dilution | |
| Sample | Diluent (NaCl) | ||
| Normal | 2 µL | – | – |
| Decreased | 4 µL | 15 µL | 135 µL |
| Increased | 2 µL | – | – |
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 change• as required following quality control procedures |
Measuring range
2‑100 g/L (30.4‑1520 µmol/L)
Lower detection limit of the test
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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:
Albumin 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 MODULAR P analyzer (x).