Solution reagent kit Genvinset® FIIFV

for mutation detectionfor factor V mutationgenomic DNA

Kit for detecting the G20210A mutation of the prothrombin (FII) gene and the G1691A mutation of the Factor V (FV) gene by Real-Time PCR using TaqMan® probes technology Information about the product Thrombophilia consists in the predisposition to form blood clots, caused by an underlying hypercoagulation state attributable to inherited or acquired disorders of blood coagulation or fibrinolysis The G20210A mutation in the prothrombin gene (FII) has been associated with an increased risk of thrombosis. Although the molecular mechanism underlying the G20210A mutation is yet unclear, it seems to cause overexpression of the prothrombin gene, thus increasing the risk of thrombosis. Furthermore, it is well documented that another missense mutation, the G1691A mutation in the gene that encodes for the coagulation Factor V (known as FV Leiden or FVL) is also associated with an increased risk of thrombophilia and venous thrombosis. INTENDED USE Genvinset® FII-FV multiplex is a semi-automated kit for the in vitro qualitative detection of the thrombophilia risk associated G20210A mutation (NCBI dbSNP rs1799963; NM_000506.5:c.*97G>A) in the prothrombin (FII) gene (OMIM: 176930) and G1691A mutation (NCBI dbSNP rs6025; NM_000130.5:c.1601G>A) in the factor V (FV) gene (OMIM: 612309) associated with thrombophilia risk in genomic DNA extracted from whole blood using Real-Time PCR technology with specific TaqMan® probes. Patients who can benefit from this determination are those referred by a specialist. The results of this test should not be the only ones on which the therapeutic decision is based