INFINITI® Warfarin Assay (IVD)

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Product Design
  • The INFINITI® Warfarin Assay is available 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 Amplification Mix and the Warfarin Assay BioFilmChip® Microarray.

  • The INFINITI Warfarin Assay is automated by the INFINITI Analyzer.
Benefits


Versatility
Multiplexed determination of 3 genetic variants on one BioFilmChip Microarray
  
Efficiency
Rapid turnaround time allows for same day results
Agility
Load and Go automation with the INFINITI Analyzer
Integrity
Replicate determinations on a single BioFilmChip Microarray ensure quality results


Genetic Variants
2C9 Variants:
*2, *3
Clinical Relevance
 *2, *3 are the commonly identified 2C9 variants shown to decrease enzymatic activity.
VKORC1 Variants:
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.
 
Genetic Variance
0.2 – 2.0 ml of peripheral whole blood in EDTA (purple-top) tube
50 ng DNA / reaction
Product Information
  
Product No.
Product Name
Description
Pack Size
03 114
03 214
03 314
INFINITI Warfarin Assay BioFilmChip
INFINITI Warfarin Assay Intellipac
INFINITI Warfarin Assay Amp Mix 		12 BioFilmChips/magazine
24 tests/Intellipac
250 ul/vial 		4 magazines/pack
2 Intellipac/pack
4 vials/pack

Please contact AutoGenomics to obtain product information.

Clicnical Relevance
  • 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.

  • There is greater than a ten-fold interpatient variability in the response to Warfarin.

Warfarin Adverse Effects
  • Warfarin exposes patients to increased risk of hemorrhage.

  • Annual incidence of associated major-bleeding complications has ranged from 1.0% to 5.0%.

  • 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.


References
1. Fanikos, John, et. al. Major bleeding complications in a specialized anticoagulation service. American Journal of Cardiology. 2005; 96: 595-98.
Copyright 2010 AutoGenomics, Inc.