DiaPharma Group, Inc.

Intended Use

Auto·Dimer® is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation products that contain D-dimer in human plasma on the instruments Hitachi 911, Hitachi 902, and Thrombolyzer Compact X/Compact XR/Combi/RackRotor.

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 the initial assessment of these conditions.

Principle

Biopool Auto·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. The unopened and unreconstituted reagents are stable until the expiration date stated on the box and vial labels when stored at 2-8 ºC.

1. Latex Reagent 1 x 13.5 ml latex particles coated with anti-D-dimer monoclonal antibody MA-8D3 suspended in HEPES buffer pH 8.5, containing stabilizers, detergent and sodium azide. Store at 2-8 °C and use within 4 weeks from opening. Instrument on-board storage:
   Hitachi 911/902 application: Stable for 4 weeks when stored onboard.
   Thrombolyzer application: Stable for 1 week when stored on-board.
2. Reaction Buffer 1 x 22 ml HEPES buffer, pH 7.0, containing stabilizers, detergent and sodium azide. Store at 2-8 °C and use within 4 weeks from opening. Instrument on-board storage:
   Hitachi 911/902 application: Stable for 4 weeks when stored onboard.
   Thrombolyzer application: Stable for 1 week when stored on-board.
3. Saline Solution 2 x 8 ml buffered saline, pH 7.3, containing sodium azide. Store at 2-8°C and use within 4 weeks from opening.
4. D-dimer Standard 0 micrograms/L 2 x 1 ml lyophilized human plasma immunodepleted of D-dimer. Stable for 10 hours at 20-25°C.
5. D-dimer Standard 3200 micrograms/L 2 x 1 ml lyophilized human plasma enriched with D-dimer. Stable for 10 hours at 20-25°C.
6. Preparation of Standard Curve sheet # 646-406.

Materials required but not provided

• Automatic analyser (Hitachi 911, Hitachi 902, or Thrombolyzer Compact X/Compact XR/Combi/RackRotor)
• Instrument applications for Hitachi 911/902 and Thrombolyzer
• D-dimer Low Control, Biopool (Cat. No. C1436) (1436)
• D-dimer High Control, Biopool (Cat. No. C1468) (1468)
• Pipettes for 125 microliter and 1000 microliter
• Pipette tips
• Test tubes

Cleared: FDA, Canadian Licensed.