Tina-quant D-Dimer

Catalog Number: 03001245322

SYSTEM INFORMATION

For cobas c 311/501 analyzers:

INTENDED USE

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.

STORAGE AND STABILITY

 D‑DI
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

CALIBRATION

 

 Calibrators S1‑S6: D‑Dimer CalibratorRefer to the calibrator package insert for instructions on dilution of standards.
Calibration mode RCM2
Calibration frequency Full calibration• after reagent lot change• every 6 months when using a single reagent lot• as required following quality control procedures

CALIBRATION MODE

CALIBRATION FREQUENCY

CALIBRATION INTERVAL MAY BE EXTENDED BASED ON ACCEPTABLE VERIFICATION OF CALIBRATION BY THE LABORATORY.

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.10‑9.00 µg FEU/mL

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

PRECISION

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:

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:

METHOD COMPARISON

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).