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Warfarin Dose Prediction Kit (PG 1639, 1075, 0430)

Relating to Drug: Warfarin

Features

  • Required only hours from blood sample to results. Designed for easy operation & analysis. U.S. EU and Global Patent Protection. Mix & Match design.
  • Accuracy has been confirmed after testing more than 400 samples.
  • CE quality certification and medical device license of Taiwan Health And Welfare Department;the registration of Singapore HSA products.

Products Registration Status

  • CE IVD
  • Taiwan IVD
  • Singapore IVD
  • US ASR

Test Method

Development of a rapid genotype assay for warfarin dosing assessment using Taqman probe and Real-Time PCR (real-time polymerase chain reaction technology). PG 1639、1075, and 0430

With PG1639, only one PCR reaction was required per assay to detect VKORC1 (-1639) genotype as GG, GA or AA.

The test is performed by comparing the sample position with the positions of the three isoforms. PG0430 detects CYP2C9*2 (c.430) sites as CC, CT or TT, and PG1075 detects CYP2C9*3 (c.1075) sites as AA, AC or CC.

Product Purpose

PG1639, PG1075, and PG0430 were identified for Warfarin dosing assessment genotypes.

VKORC1 and CYP2C9 partial locus variants have been found to be highly relevant to the maintenance dose of Warfarin .

Warfarin, which does too low to be effective, produces blood clots and ,conversely it causes unanticipated massive bleeding.

Individual genes allow anticoagulants to adjust to the most appropriate dose, so the FDA recommends genetic testing before use to enhance drug safety.

Does Prediction

  • CYP2C9 * 3 (c.1075):AA、AC、CC
  • CYP2C9 * 2 (c.430):CC、CT、TT
  • VKORC1 (-1639):GG、GA、AA
  • The FDA recommends therapy by estimating the therapeutic dose in patients new to warfarin be calculated using the following website www.warfarindosing.org which automatically calculate the correct results for individual differences in race, height, weight, age, genotype, INR, current medications, liver disease, smoking…etc.

Product Performance

Process

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