INFINITI System Assay for Factor II (IVD)

  • The INFINITI System Assay for Factor II is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).
  • The INFINITI System Assay for Factor II is indicated for use as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
  • The INFINITI System Assay for Factor II utilizes the Factor II Intellipac, Factor II Amp Mix and Factor II BioFlimChip Microarray.
  • The INFINITI System Assay for Factor II is automated by the INFINITI Analyzer.
Analytes Detected: 
  • Factor II (Prothrombin) G20210A
Features: 
  • Determination of 1 genetic variant for Factor II.
  • 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: 
  • Uses 0.2 - 2.0 mL of peripheral whole blood in EDTA (purple top) tube.
  • Requires 50 ng DNA / reaction
Clinical Relevance: 
  • 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 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.1

INFINITI System Assay for Factor II (IVD)