Methodology

This assay utilizes the Cepheid Xpert® FII & FV qualitative in vitro diagnostic genotyping test, as described in the FDA approved assay package insert, for the detection of Factor V (F5) and Prothrombin (F2) alleles from sodium citrate or EDTA anticoagulated whole blood. This test is performed on the Cepheid GeneXpert® Dx System which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in whole blood using real-time Polymerase Chain Reaction (PCR) assays based on Scorpion® PCR technology. Note: F5 (NM_000130​.4):c.1601G>A, R534Q or Factor V Leiden is also referred to as c.1691G>A, p.R506Q in the literature.  F2 (NM_000506.3):c.*97G>A is also referred to as G20210A and g.20210G>A in the literature.