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.
- Factor II (Prothrombin) G20210A
- 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
- The Factor II (Prothrombin) variant gene is the second most common genetic defect for inherited thrombosis.
- 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
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