Factor II-V Leiden

NFINITI 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


  • 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
  • ‚ÄúPatients 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


  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

To obtain the IFU for this application, please Click Here.

For more product information please Contact Us.