INFINITI Factor II-V Leiden Assay

  • The INFINITI Factor II-V Leiden Assay is CE Marked.
  • The INFINITI Factor II-V Leiden is indicated for use as an aid to diagnosis in the evaluation of patients with suspected Thrombophilia.
  • The INFINITI Factor II-V Leiden utilizes the Factor II-V Leiden Panel Intellipac, Factor II-V Leiden Panel Amp Mix and Factor II-V Leiden Panel BioFlimChip Microarray.
  • The INFINITI Factor II-V Leiden Assay is automated by the INFINITI Analyzer.
Analytes Detected: 
  • Factor II (Prothrombin): G20210A
  • Factor V Leiden: G1691A
  • Multiplexed determination of 2 genetic variants on one BioFilmChip Microarray
  • 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 0.2 - 2.0 ml of peripheral whole blood in EDTA (purple-top) tube
Clinical Relevance: 
  • The Factor II (Prothrombin) variant gene is the second most common genetic defect for inherited thrombosis.
  • The Factor V Leiden mutation is the most common variant associated with inherited thrombosis.
  • FV 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.
  • 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.
Clinical Utility: 
  • The increased risk of venous thrombosis in patients who are heterozygous for the prothrombin (G20210A) gene polymorphism is 3-fold.1
  • Homozygotes for this polymorphism have been described but are very uncommon.1
  • Patients with a previous, or current, thrombotic event that have the prothrombin (G20210A) gene polymorphism are potentially at increased risk for recurrence.1
  • Patients with the prothrombin (G20210A) mutation are at increased risk of thrombosis when exposed to other risk factors such as:
  • (1) smoking
  • (2) pregnancy
  • (3) Obesity
  • (4) Oral Contraceptives
  • (5) Immobility1
  • "The risk of thrombosis is substantially increased for patients with multiple genetic risk factors (i.e., the "double hithypothesis") including the prothrombin (G20210A) gene mutation, Factor V Leiden Leiden mutation, hyperhomocysteinemia, methylenetetrahydrofolate reductase (MTHFR) thermolabile polymorphism, protein C deficiency, protein S deficiency, and antiphospholipid antibody syndrome(s)."1
  • Definition and confirmation of the prothrombin (G20210A) gene polymorphism is necessary for genetic counseling of patients for themselves and family members.
  2. 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. 
  3. Salomon O. et al; Single and Combined Prothrombotic Factors in Patients With Idiopathic Venous Thromboembolism;
  4. Arteriosclerosis Thrombosis and Vascular Biology, 1999, 19: 511-518 © 1999 American Heart Association