BioMedica Diagnostics products

ACTICHROME® Heparin (Anti-FXa) is an amidolytic chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma via the measurement of Factor Xa activity.The inhibitory effect of antithrombin III (ATIII) on Factor IIa (thrombin), Factor Xa, and other coagulation serine proteases in plasma is increased several thousand-fold by heparin. This inhibition accounts for the anticoagulant effect of heparin. Assaying plasma heparin levels by the measurement of their Anti-Factor Xa activity is a necessary tool for monitoring the efficacy of heparin treatment efficacy. Low molecular weight heparin (LMWH) preparations appear to catalyze the reaction between thrombin (FIIa) and AT-III less readily than the reaction between Factor Xa and AT-III. Unfractionated heparin (UFH) catalyzes both reactions equally. 

The DVVtest, offered by BioMedica Diagnostics, is an in vitro diagnostic tool used in the detection of Lupus Anticoagulant (LA). This test employs Factor X activator derived from Russell's Viper Venom to directly convert Factor X to Factor Xa in the presence of phospholipids and calcium. This action bypasses the contact and intrinsic pathways of the coagulation cascade, thus minimizing interference from deficiencies in factors VIII, IX, XI, and XII or their respective inhibitors. The presence of LA is indicated by prolonged phospholipid-dependent clotting time. The DVVtest formulation enhances both sensitivity and specificity, making it suitable for use in samples with normal activated partial thromboplastin time (APTT). It is CE Marked, FDA 510(K) cleared, and registered with Health Canada, underscoring its adherence to rigorous quality and safety standards.

DVVconfirm® is the high phospholipid containing coagulation reagent to be used in conjunction with DVVtest to confirm the presence of Lupus Anticoagulants (LA) in human plasma. The identification of Lupus Anticoagulants (LA) in plasma is a diagnostic hallmark of the Antiphospholipid Syndrome (APS), an autoimmune disorder clinically characterized by arterial and venous thrombosis, recurrent spontaneous fetal loss, thrombocytopenia and neurological disorders. Lupus Anticoagulants are immunoglobulins of the IgG, IgM and IgA isotypes that prolong one or more of the in vitro phospholipid-dependent coagulation tests: Activated partial thromboplastin time (aPTT), dilute prothrombin time (dPT), Textarin time or dRVVT.

BioMedica Diagnostics specializes in providing an array of coagulation diagnostic tests, with a focus on precision and compliance with international standards. The QuikCoag line includes a range of in vitro diagnostic (IVD) assays such as APTT-EA, PT-HS, Fibrinogen, Thrombin Time, and various calcium chloride and buffer reagents. These assays support the detection and evaluation of hemostatic and thrombotic disorders. For instance, the Thrombin Time assay is designed to identify malfunctions in the clotting process by measuring the time required for fibrin clot formation after thrombin reagent introduction. The assays are CE Marked, Health Canada Registered, and FDA 510(k) Cleared, ensuring their reliability and widespread acceptance. They are designed to accommodate laboratory needs across different geographic regions while maintaining consistency in testing, essential for accurate diagnostics and patient care.