Intended use: Automated latex enhanced immunoassay for the quantitative determination of D-Dimer in human citrated plasma on IL Coagulation Systems for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude venous thromboembolism (VTE) in outpatients suspected of deep venous thrombosis (DVT) and pulmonary embolism (PE).
Principle: Suspension of polystyrene latex particles of uniform size, coated with a monoclonal antibody highly specific for the D-Dimer domain included in fibrin soluble derivatives. When a plasma containing D-Dimer is mixed with the Latex Reagent and the Reaction Buffer, the coated latex particles agglutinate.
Vials and volumes:
- 4 x 3 mL Latex Reagent (lyo)
- 4 x 9 mL Reaction Buffer (liq)
- 2 x 1 mL D-Dimer Calibrator (lyo)
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