Thrombophilia and coagulation inhibitor IVDs

Intended purpose

The Xpert Factor II & Factor V Assay is a qualitative IVD genotyping test to detect FII and FV alleles from sodium citrate or EDTA anticoagulated whole blood. This test provides results for FII (G20210A) and FV Leiden (G1691A) mutations to aid in the diagnosis in individuals with suspected thrombophilia.