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
Features: 
  • 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.
References: 
  1. http://pathology.mc.duke.edu/coag/PTGlflyer2.html
  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 http://pathology.mc.duke.edu/coag/PTGlflyer2.html

Fact II-V CE IFU