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Pharmacogenetics · Assays
Viennalab Distributed by Goffin Diagnostics

VKORC1 -1639G>A PCR Assay

The Viennalab VKORC1 -1639G>A RealFast Assay determines the three possible genotypes of the VKORC1 promoter variant -1639G>A in a human genomic DNA extract by real-time PCR: GG, GA and AA. This tag-SNP accounts for a large part of the variation between patients in the dose requirement for oral anticoagulants such as warfarin, phenprocoumon and acenocoumarol. VKORC1 is the target of the vitamin K antagonists prescribed for the prevention and treatment of thromboembolic disorders. These drugs have a narrow therapeutic range, and homozygous carriers of the A allele need a lower dose than carriers of the G allele.

Real-Time PCR CE-IVD Viennalab 1 Unit (100 Reactions), 1 Unit (32 Reactions)
Technique
Real-Time PCR
Brand
Viennalab
Packaging
1 Unit (100 Reactions), 1 Unit (32 Reactions)
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Product details

This kit in detail

  • Detects the VKORC1 promoter variant -1639G>A
  • Distinguishes the GG, GA and AA genotypes
  • Supports dosing of warfarin, phenprocoumon and acenocoumarol
  • Real-time PCR with variant-specific probes
  • Whole peripheral blood, dried blood spots, buccal swabs or saliva
  • 32 or 100 reactions per kit, REF 7-193 and REF 7-190

The Viennalab VKORC1 -1639G>A RealFast Assay determines the genotype of the VKORC1 promoter variant -1639G>A, the single strongest genetic predictor of the dose requirement for coumarin anticoagulants.

Clinical background

Vitamin K epoxide reductase, the product of VKORC1, is the target of the vitamin K antagonists used to prevent and treat thromboembolic disorders. These drugs have a narrow therapeutic range and a wide variation in dose response, which complicates the start of treatment: too high a dose causes bleeding, too low a dose leaves the patient at risk of thromboembolism. The -1639G>A variant lies in the promoter and lowers expression of the gene.

Interpretation

The assay distinguishes the GG genotype (normal dose requirement), GA (intermediate) and AA (low). Homozygous carriers of the A allele need a lower dose of warfarin, phenprocoumon or acenocoumarol than heterozygous carriers or carriers of two G alleles. Empirical dosing leads to repeated dose changes while the international normalized ratio (INR) fluctuates; dosing guided by the genotype shortens that phase.

Method

The assay uses real-time PCR with the RealFast 2x Genotyping Mix and the VKORC1 -1639G>A Assay Mix. A GG-control and an AA-control are supplied. DNA isolated from whole peripheral blood, dried blood spots, buccal swabs or saliva can be used, and DNA extraction reagents are not supplied with the kit; ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), ordered separately.

  • RealFast 2x Genotyping Mix (white cap, 1000 / 320 µl)
  • VKORC1 -1639G>A Assay Mix (purple cap, 550 µl)
  • VKORC1 -1639G>A GG-Control (green cap, 75 µl)
  • VKORC1 -1639G>A AA-Control (red cap, 75 µl)

REF 7-190 (100 reactions) and REF 7-193 (32 reactions). DNA extraction reagents are not supplied with the kit. ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), which is ordered separately.

Documentation

Datasheets and regulatory documentation

Everything your quality team needs for evaluation and procurement.

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