DISCONTINUED -- REPLACEMENT: Biopool Auto-Dimer (K1431)
For in vitro diagnostic use
Intended Use
Biopool MiniQuant D-dimer is a 3-minute immunoturbidimetric assay used for the quantitative determination of the fibrin degradation products that contain D-dimer in human citrated plasma. The MiniQuant D-dimer reagents are intended to be used only on the Biopool® MiniQuant-1 instrument.
Summary
D-dimer containing moieties are formed by plasmin degradation of factor XIIIa cross-linked fibrin. Elevated levels of D-dimer are found in clinical conditions such as deep vein thrombosis (DVT), pulmonary embolism (PE) and disseminated intravascular coagulation (DIC). Laboratory measurements of fibrin degradation products, including D-dimer, have significance in screening for these conditions.
Principle
Biopool® MiniQuant® D-dimer is a turbidimetric assay that utilizes antibody coated latex particles. In the presence of D-dimer, the particles aggregate and turbidity increases. The increase in scattered light is proportional to the amount of D-dimer in the sample. The latex particles are coated with a monoclonal antibody that reacts with fibrin D-dimer or fragment D of fibrin. The antibody has no cross reactivity with fibrinogen.This allows for the determination of D-dimer in human plasma.
Reagents -- Composition, Packaging, Storage and Stability
The reagents are lot-specific. Lots are not interchangeable. All unopened and unreconstituted reagents are stable until the expiration date stated on the box and vial labels when stored at 2-8ºC.
- Latex Reagent 2 x 2.5 ml of 0.30% latex reagent in HEPES buffer pH 8.5, with 0.2 g/L sodium azide, protein stabilizers and detergents. When opened, stable for 4 weeks at 2-8ºC. To reduce prolonged storage at elevated temperatures, an aliquot of the latex suitable for daily work should be transferred to a smaller vial, e.g. a 2 ml screw capped polypropylene "cryo-type" vial. Place this vial in the incubator position and allow the latex to equilibrate at the working temperature of the instrument (37ºC) for 15 minutes before use. Return to 2-8ºC at end of working day. When handled in this way, the latex may be stored for 8 hours a day at 37ºC during 10 working days without appreciable loss of reactivity.
- Reaction Buffer 2 x 2.5 ml of HEPES buffer pH 7.0, containing 0.2 g/L sodium azide and detergents. When opened, stable for 4 weeks at 2-8ºC.
- Saline Solution 2 x 8 ml of buffered saline pH 7.3, containing 0.2 g/L sodium azide. Used for reconstitution of lyophilized reagents and sample dilutions. When opened, stable for 4 weeks at 2-8ºC.
- D-dimer Standard 0 ?g/L 2 vials of lyophilized plasma immunodepleted for D-dimer, used as 0 µg/L standard. Stable for 10 hours at 20-25ºC.
- D-dimer Standard 3200 ?g/L 2 vials of lyophilized human plasma enriched with D-dimer at a level of approximately 3200 µg/L. See Standard and Control Preparation flyer section 1 for lot specific assayed values. Stable for 10 hours at 20-25ºC.
- D-dimer Low Control 2 vials of lyophilized human plasma enriched with D-dimer at a level of approximately 300 µg/L. See Standard and Control Preparation flyer section 2 for lot specific assayed values. Stable for 10 hours at 20-25ºC or 1 week at 2-8ºC. A single freeze-thaw cycle involving 4 weeks of storage at -20ºC does not affect the assay response.
- D-dimer High Control 2 vials of lyophilized human plasma enriched with D-dimer at a level of approximately 2000 µg/L. See Standard and Control Preparation flyer section 2 for lot specific assayed values. Stable for 10 hours at 20-25ºC or 1 week at 2-8ºC. A single freeze-thaw cycle involving 4 weeks of storage at -20ºC does not affect the assay response.
- Standard and Control Preparation flyer (# 646-190)
Materials required but not provided
- Biopool® MiniQuant®-1 instrument (Cat. No. I1466) (1466)
- MiniQuant® Cuvettes (Cat. No. C1469) (1469)
- Pipettes for 25, 50, 100 and 1000 µl
- Pipette tips
- Test tubes
Assay Range: linear from 75-3,200 µg/L
Cleared: FDA, Canadian Licensed