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.
- 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
- 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.
- 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.
- 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;
- Arteriosclerosis Thrombosis and Vascular Biology, 1999, 19: 511-518 © 1999 American Heart Association http://pathology.mc.duke.edu/coag/PTGlflyer2.html