Catalog Number: 03001245322
For cobas c 311/501 analyzers:
In vitro test for the quantitative immunological determination of fibrin degradation products (D‑Dimer and X‑oligomers) in human plasma on Roche/Hitachi cobas c systems.1,2In conjunction with a non‑high clinical probability assessment, a normal (< 0.5 µg FEU/mL) result excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity.
|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
|Calibrators||S1‑S6: D‑Dimer CalibratorRefer to the calibrator package insert for instructions on dilution of standards.|
|Calibration frequency||Full calibration• after reagent lot change• every 6 months when using a single reagent lot• as required following quality control procedures|
0.10‑9.00 µg FEU/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:
D‑Dimer values for human citrated 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 917 analyzer (x).