INFINITI Factor V Leiden Assay

  • The INFINITI Factor V Leiden Assay is CE Marked.
  • The INFINITI Factor V Leiden is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
  • The INFINITI Factor V Leiden is used to determine genetic variants in Factor V Leiden Leiden.
  • The INFINITI Factor V Leiden utilizes the Factor V Leiden Intellipac, Factor V Leiden Amp Mix and Factor V Leiden BioFlimChip Microarray.
  • The INFINITI Factor V Leiden Assay 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: 
  • Requires 50 ng DNA / reaction.
  • Requires  0.2 - 2.0 ml of peripheral whole blood in EDTA (purple-top) tube
Clinical Relevance: 
  • The Factor V Leiden mutation is the most common variant associated with inherited thrombosis.
  • 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). 
  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

INFINITI Factor V Leiden Assay CE