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 II alleles from sodium citrate or EDTA anticoagulated whole blood. This test is FDA approved for both Factor V and Factor II, however only the ordered test is analyzed and reported. 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: F2 (NM_000506.3):c.*97G>A is also referred to as G20210A and g.20210G>A in the literature.