DIMERTEST® Latex Kit，D-二聚体乳胶凝集

INTENDED USE
The DIMERTEST® Latex Assay is intended for the rapid qualitative or semi-quantitative evaluation of circulating derivatives of cross-linked fibrin degradation products (XL-FDP) in human plasma.

SUMMARY AND EXPLANATION OF THE TEST
During blood coagulation, fibrinogen is converted to fibrin by the activation of thrombin. The resulting fibrin monomers polymerize to form a soluble gel of non-cross-linked fibrin. This fibrin gel is then converted to cross-linked fibrin by thrombin activated Factor XIII to form an insoluble fibrin clot. Production of plasmin, the major clot-lysing enzyme, is triggered when a fibrin clot is formed.
Fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme plasmin to yield degradation products, but only degradation products from cross-linked fibrin contain D-dimer1-3. Therefore, cross-linked fibrin degradation products (XL-FDP) are a specific marker of fibrinolysis.

TEST PRINCIPLE
DIMERTEST® Latex is a rapid agglutination assay utilizing latex beads coupled with a highly specific D-dimer monoclonal antibody. XL-FDP present in a plasma sample bind to the coated latex beads, which results in visible agglutination occurring when the concentration of D-dimer is above the threshold of detection of the assay.