EliTechGroup Molecular Diagnostics, Puteaux, France, has received CE marking for its Coagulation Elite MGB kit, a multiplex assay for the detection of genetic variants associated with higher risk of deep vein thrombosis. The kit is intended to detect and differentiate the most common genetic risk variants responsible for thrombosis and embolisms: coagulation Factor V variant G1691A (Leiden); coagulation Factor II variant G20210A; and MTHFR variant C677T. The detection of these single nucleotide polymorphisms is especially required in individuals with personal or familial history of recurrent thrombosis. The kit is a monoreagent, ready-to-use, real-time polymerase chain reaction assay, and is the first genetic testing assay to receive CE marking validated on the system. It showed 100% specificity for each variant, and 98.5%, 100%, and 100% sensitivity, respectively, for Factor V, Factor II, and MTHFR. For more information, visit EliTechGroup.
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