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.