Factor V Leiden

INFINITI System Assay for Factor V Leiden (IVD)

  • The INFINITI System Assay for Factor V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).
  • The INFINITI System Assay for Factor V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
  • The INFINITI System Assay for Factor V utilizes the Factor V Intellipac, Factor V Amp Mix and Factor V BioFlimChip Microarray.
  • The INFINITI System Assay for Factor V is automated by the INFINITI Analyzer.

Analytes Detected: 

  • Factor V Leiden G1691A


  • Determination of genetic variant for Factor V Leiden.
  • Rapid turnaround time enhances workflow efficiency.
  • Load & Go automated on the INFINITI/INFINITI PLUS Analyzer.
  • Replicate determinations on a single BioFilmChip Microarray ensures quality results.

Sample Type and Volume: 

  • Uses 0.2 – 2.0 mL of peripheral whole blood in EDTA (purple top) tube.
  • Requires 50 ng DNA / reaction

Clinical Relevance: 

  • The Factor V Leiden mutation is the most common variant associated with inherited thrombosis.1
  • This mutation has a high prevalence in the general population (4 – 6% of US Population), and accounts for 85-95% of activated protein C resistant cases.1
  • Enhanced risk of venous thrombosis, with the presence the Factor V Leiden variant, with odds ratios (ORs) of 3 to 8 in heterzygotes and 30 to 140 OR in homozygotes.2

Clinical Utility: 

  • The risk of thrombosis is substantially increased for patients with multiple genetic risk factors (i.e. The “double hit hypothesis”) including factor V Leiden mutation, hyperhomocysteinemia, protein C deficiency, protein S deficiency and antiphospholipid antibody syndrome(s).3


  1. Grody W, Griffin J, Taylor A, Korf B, Heit, J. (2001) American College of Medical Genetics Consensus Statement on Factor V Leiden Leiden Mutation Testing, Genetics in Medicine, 3:2, 139-147.2. 
  2. Salomon O. et al; Single and Combined Prothrombotic Factors in Patients With Idiopathic Venous Thromboembolism;
  3. Arteriosclerosis Thrombosis and Vascular Biology, 1999, 19: 511-518 © 1999 American Heart Association http://pathology.mc.duke.edu/coag/PTGlflyer2.html

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