Factor V Leiden (FVL)

Detection of coagulation Factor V LEIDEN G1691A genetic polymorphism by Loop-mediated isothermal amplification.



24 reactions


96 reactions


Kit CE


The LAMP Human FV LEIDEN KIT (rs6025) is an in vitro diagnostic test intended for the qualitative detection of homozygous or heterozygous coagulation Factor V Leiden G1691A polymorphism (also known as G1601A) by Loop-mediated isothermal amplification (LAMP) in patients with suspected thrombophilia. This CE-IVD assay is dedicated to professional use in diagnostic laboratory. The device is not for self-testing.


Factor V Leiden thrombophilia is characterized by a poor anticoagulant response to activated protein C (APC) and an increased risk for venous thromboembolism (VTE). Deep venous thrombosis (DVT) is the most common VTE, with the legs being the most common site. Factor V Leiden thrombophilia is suspected in individuals with a history of venous thromboembolism (VTE) manifest as deep vein thrombosis (DVT) or pulmonary embolism, in women with a history of VTE during pregnancy or in association with oral contraceptive use, and in individuals with a personal or family history of recurrent thrombosis. The variant Factor V Leiden is inactivated by APC at a rate approximately ten times slower than normal factor V and persists longer in the circulation, resulting in increased thrombin generation and a mild hypercoagulable state, reflected by elevated levels of prothrombin fragment F1+2 and other activated coagulation markers. The diagnosis of factor V Leiden thrombophilia is made either using a coagulation screening test (APC resistance assay) or by DNA analysis of the F5 gene which encodes the factor V protein, the only gene associated with factor V Leiden thrombophilia. The term "factor V Leiden" refers to the specific G-to-A substitution at nucleotide 1691 in the gene for factor V that predicts a single amino-acid replacement (Arg506Gln) at one of three APC cleavage sites in the factor V molecule.


Reference :

- Desjonquères, A., Ménard, A., Detemmerman, L., Ternisien, C., Fouassier, M., Gillet, B., … Le Bris, Y. (2019). Confirmed validation of an innovative PCR-assay without DNA extraction for multiplex diagnosis of factor V Leiden and prothrombin gene variants. Thrombosis Research, 183, 143–145. Available from : Thrombosis Research


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