Catalog Number: 05480167190
RF‑II: ACN 8017
In vitro test for the quantitative determination of Rheumatoid Factors (RF‑II) in human serum and plasma on Roche/Hitachi cobas c systems. Measurements may be used as an aid in the diagnosis of rheumatoid arthritis.
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:
RF‑II | |
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 |
cobas c 701/702 test definition | |||
Assay type | 2‑Point End | ||
Reaction time / Assay points | 10 / 21‑29 | ||
Wavelength (sub/main) | 800/570 nm | ||
Reaction direction | Increase | ||
Unit | IU/mL | ||
Reagent pipetting | Diluent (H2O) | ||
R1 | 90 µL | – | |
R3 | 30 µL | – | |
Sample volumes | Sample | Sample dilution | |
Sample | Diluent (NaCl) | ||
Normal | 3 µL | – | – |
Decreased | 6 µL | 15 µL | 135 µL |
Increased | 6 µL | – | – |
Calibration interval may be extended based on acceptable verification of calibration by the laboratory.
Calibrators | S1: H2OS2‑6: Preciset RF |
Calibration mode | RCM |
Calibration frequency | Full calibration• after 180 days during shelf life• after reagent lot change• as required following quality control procedures |
Measuring range
10‑130 IU/mL
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:
RF 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).