Lab Med Online.  2014 Oct;4(4):198-202. 10.3343/lmo.2014.4.4.198.

Evaluation of the Verigene Warfarin Metabolism Nucleic Acid Test Kit for the Rapid Detection of CYP2C9 and VKORC1 Polymorphisms

Affiliations
  • 1Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. chez@catholic.ac.kr
  • 2Catholic Laboratory Development and Evaluation Center, College of Medicine, The Catholic University of Korea, Seoul, Korea.
  • 3Department of Internal Medicine, Division of Cardiology, Seoul St. Mary's Hospital, Seoul, Korea.

Abstract

BACKGROUND
Warfarin is a widely used oral agent for anticoagulation therapy. Warfarin has a narrow therapeutic index and a wide variation in the interindividual therapeutic dosage. Recently, genotypes of CYP2C9 and VKORC1 have been found to account for 30-40% of the warfarin dosing variability, and a variety of commercial genotyping assays are being introduced. In this study, we evaluated the Verigene Warfarin Metabolism Nucleic Acid test (Verigene Warfarin assay; Nanosphere, USA) for its accuracy and clinical utility in genotyping CYP2C9*2, CYP2C9*3, and VKORC1 1173C>T.
METHODS
We compared the Verigene Warfarin assay with direct sequencing for accuracy in determining the genotypes of CYP2C9*2, CYP2C9*3, and VKORC1 1173C>T using 50 patient samples and 3 commercial DNA samples with known genotypes. The method was also evaluated for turn-around time, hands-on time, and feasibility.
RESULTS
The Verigene Warfarin assay demonstrated 100% accuracy for identifying CYP2C9*2, CYP2C9*3, and VKORC1 1173C>T. The turn-around time and hands-on time were 3 hr and 2 min, respectively. The no-call error rate at first attempt was estimated to be 2%.
CONCLUSIONS
The Verigene Warfarin assay provides rapid and accurate genotype results. Considering there are only a few steps requiring manual intervention, it would be feasible to implement this assay even in clinical laboratories that lack considerable expertise in molecular diagnostics.

Keyword

Warfarin; CYP2C9; VKORC1
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