INFINITI System Assay for Factor II-V Leiden (IVD)

  • The INFINITI System Assay for Factor II-V is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).
  • The INFINITI System Assay for Factor II-V is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
  • The INFINITI System Assay for Factor II-V utilizes the Factor II Intellipac, Factor II-V Amp Mix and Factor II-V BioFlimChip Microarray.
  • The INFINITI System Assay for Factor II-V is automated by the INFINITI Analyzer.
Analytes Detected: 
  • Factor II (Prothrombin) G20210A
  • Factor V Leiden G1691A
Features: 
  • Multiplexed determination of 2 genetic variants.
  • Rapid turnaround time enhances workflow efficiency.
  • Load & Go automated on the INFINIT/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
  • The Factor V Leiden mutation is supported by a high prevalence in the general population (4-6% of US population), and accounts for 85-95% of activated protein C resistant cases. 1
  • Presence of the Factor V Leiden variant enhances the risk of venous thrombosis, with odds ratios (ORs) of 3 to 8 in heterozygotes and 30 to 140 in homozygotes.2
  • The Factor II (prothrombin) variant gene is the second most common genetic defect for inherited thrombosis.
Clinical Utility: 
  • "The increased risk of venous thrombosis in patients who are heterzygous for the prothrombin (G20210A) gene polymorphism is 3-fold."3
  • "Homozygotes for this polymorphism have been described but are very uncommon."3
  • Patients with a previous, or current, thrombotic event that have the prothrombin (G20210A) gene polymorphism are potentially at increased risk for recurrence.2
  • “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 hit hypothesis") 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 and family members.1
References: 
  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. Salomon, O., et.al., Single and Combined Prothrombotic Factors in Patients With Idiopathic Venous Thromboembolism, Arterioscler Thromb Vasc Biol. 1999;19:511-518.
  3. http://pathology.mc.duke.edu/coag/PTGlflyer2.html

INFINITI System Assay for Factor II-V Leiden (IVD)