INFINITI Warfarin Assay (IVD)
- The INFINITI Warfarin Assay is FDA 510(k) cleared as an in vitro diagnostic assay (IVD).
- The INFINITI Warfarin Assay is indicated for use to identify individuals at risk for sensitivity to Warfarin.
- The INFINITI Warfarin Assay utilizes the Warfarin Assay Intellipac, Warfarin Assay Amp Mix and Warfarin Assay BioFlimChip Microarray.
- The INFINITI Warfarin Assay is automated by the INFINITI Analyzer.
- CYP450 2C9: *2, *3
- Clinical Relevance: *2, *3 are the commonly identified 2C9 variants shown to decrease enzymatic activity.
- VKORC1: 3673 (-1639G>A)
- Clinical Relevance: 3673 = (-1639G>A) is the commonly identified VKORC1 variant and could be predictive of an individual’s response to Warfarin.
- Multiplexed determination of 3 genetic variants.
- 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
- Warfarin is the most widely prescribed oral anticoagulant that acts by inhibiting vitamin K-dependent coagulation factors.
- Warfarin is used to treat various disorders, including venous thrombosis, atrial fibrillation, pulmonary embolism, acute myocardial infarction and following heart valve replacement.
- In the US, more than 3,000,000 new prescriptions are being written every year, and the total number of warfarin prescriptions has increased by 45 percent between 1999 and 2004.1
- There is greater than a ten-fold interpatient variability in the response to Warfarin.1
- Warfarin exposes patients to increased risk of hemorrhage.
- Annual incidence of associated major-bleeding complications has ranged from 1.0% to 5.0%.1
- Annual incidence of fatal hemorrhages has been reported as 0.5% to 1.1%. 1
- Major bleeding occurred during the first 90 days of treatment in 50% of patients.1
- Adverse effects of warfarin treatment account for 15 percent of all severe adverse effects.1
- Fanikos, John, et. al. Major bleeding complications in a specialized anticoagulation service. American Journal of Cardiology. 2005; 96: 595-98.
To obtain the IFU for this application, please Click Here.
For more product information please Contact Us.