Tina-quant D-Dimer

Catalog Number: 03001245322

SYSTEM INFORMATION

Test D-DI, test ID 0-758

INTENDED USE

In vitro test for the quantitative immunological determination of fibrin degradation products (D-Dimer and X-oligomers)​1,​2 in human plasma on COBAS INTEGRA systems.

STORAGE AND STABILITY

Shelf life at 2-8 °C See expiration date on cobas c pack label
COBAS INTEGRA 400 plus system
On-board in use at 10-15 °C 12 weeks
COBAS INTEGRA 800 system
On-board in use at 8 °C 12 weeks

Specimen collection and preparation

COBAS INTEGRA 400 PLUS TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1/R2-S
Reaction direction Increase
Wavelength A/B 659 nm
Calc. first/last T0/38
Unit µg/mL

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 90 µL
R2 90 µL
Sample 5 µL 10 µL
Total volume 195 µL

Diluent (H2O)
R1 90 µL
R2 90 µL
Sample 5 µL 10 µL
Total volume 195 µL

COBAS INTEGRA 800 test definition

Calibration 

COBAS INTEGRA 800 TEST DEFINITION

Measuring mode Absorbance
Abs. calculation mode Endpoint
Reaction mode R1-R2-S
Reaction direction Increase
Wavelength A/B 659 nm
Calc. first/last T0/53
Unit µg/mL

Pipetting parameters

PIPETTING PARAMETERS

Diluent (H2O)
R1 90 µL
R2 90 µL
Sample 5 µL 10 µL
Total volume 195 µL

Calibration 

CALIBRATION

CALIBRATION DILUTION RATIO

CALIBRATION MODE

CALIBRATION REPLICATE

CALIBRATION INTERVAL

CONTROL AFTER CALIBRATION

LIMITS AND RANGES

Measuring range

MEASURING RANGE

0.1-9.0 µg FEU/mL

LOWER LIMITS OF MEASUREMENT

Lower detection limit of the test

SPECIFIC PERFORMANCE DATA

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

PRECISION

Reproducibility was determined using human samples and controls in an internal protocol (repeatability n = 21, intermediate precision n = 21). The following results were obtained:

REPRODUCIBILITY WAS DETERMINED USING HUMAN SAMPLES AND CONTROLS IN AN INTERNAL PROTOCOL (REPEATABILITY N = 21, INTERMEDIATE PRECISION N = 21). THE FOLLOWING RESULTS WERE OBTAINED:

INTERMEDIATE PRECISION

METHOD COMPARISON

D-Dimer values for human citrated plasma samples obtained on a COBAS INTEGRA 700 analyzer with the COBAS INTEGRA Tina-quant D-Dimer reagent (y) were compared to the same reagent on a Roche/Hitachi 717 analyzer (x).

BABLOK W, PASSING H, BENDER R, ET AL. A GENERAL REGRESSION PROCEDURE FOR METHOD TRANSFORMATION. APPLICATION OF LINEAR REGRESSION PROCEDURES FOR METHOD COMPARISON STUDIES IN CLINICAL CHEMISTRY, PART III. J CLIN CHEM CLIN BIOCHEM 1988 NOV;26(11):783-790.