3021, 3321 – D-Dimer Latex

Intended Purpose

The D-Dimer Latex is a qualitative and semi-quantitative immunoassay for the determination of circulating derivatives of cross-linked fibrin degradation products (XL-FDP, D-Dimer) in human plasma. The D-Dimer Latex is intended as an aid in the diagnosis of embolic or thrombotic events in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Fibrinolysis, the catalytic breakdown of the fibrin in blood clots, is an important constituent of blood clotting disorder. The activation of thrombin, during blood clotting process, converts fibrinogen to fibrin, which polymerizes to form non-cross-linked soluble gel. Thrombin activated factor XIII converts the fibrin gel to cross-linked fibrin, leading to insoluble fibrin clot; this triggers the production of plasmin, the main clot-lysing enzyme. The fibrinolytic enzyme, plasmin, cleaves fibrinogen and fibrin into degradable products; only degradation product from cross-linked fibrin contain D-Dimer, hence this degradation product (XL-FDP) serve as a diagnostic marker of the blood clotting disorder, fibrinolysis.

Product Specifications

Title D-Dimer Latex
Product code 3021 or 3321
Indication Blood clotting disorders in embolic or thrombotic events
Description Latex agglutination test for the qualitative and semi-quantitative detection of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma
Format Agglutination slide with latex beads coated with monoclonal antibody against D-Dimer
Incubation time 3 min.
Sample volume 20 µL plasma
No. of determinations 50 (50 x 1) or 100 (100 x 1) Determinations

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  SDS [REF 3021, 3321][eng]   SDS [REF 3021, 3321][deu]

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.