The SIMPLIRED whole red blood cell agglutination assay for the qualitative detection of cross-linked fibrin degradation products (XL-FDP), including D-dimer, is intended for use as a clinical aid in the diagnosis of Deep Vein Thrombosis (DVT), Disseminated Intravascular Coagulation (DIC), and Pulmonary Embolism (PE). The testing format allows medical professionals at virtually any testing location to utilize the procedure, including hospital laboratories, reference laboratories, physician office laboratories, clinics and emergency rooms.
    This two-minute test procedure features exceptional sensitivity (120 ng/mL cutoff), specificity, precision, and high negative predictive values (NPV). Performed by using a 10µL sample of whole blood, assay displays negligible interferences from fibrin degradation products X, Y, D, and E, as well as fibrinogen concentrations up to 1,000 mg/mL.
    Each test kit comes complete with sufficient reagent and consumables to perform 40 tests, along with positive and negative quality control materials.
American Diagnostica Inc
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