Features and Advantages:1. High Specificity: The use of Taqman-MGB probe method, effectively enhance the genotyping specificity
2. High Accuracy: Paraffin sealed sample, the whole process is carried out in a closed tube with beta -actin internal control system that effectively prevents product contamination and false negatives
3. High Sensitivity: accurate genotyping down to 1ng/μL in DNA samples
4. Simplicity and Fastness: the kit is simple and easy to operate, the detection cycle is short (1.5hours), and the result is reliable.
Background:Also known as Warfarin Sensitivity Testing, it is the most widely used oral anticoagulant nowadays. Its effect in preventing and treating thromboembolic diseases and the convenience and economy of oral administration are obvious. But Warfarin therapeutic window is very narrow, and medication for individual differences and racial differences to achieve the same effect at high and low doses can differ by 10 times or more. Various studies have shown that this is associated to the genetic polymorphisms of cytochrome P450 enzyme CYP2C9 and vitamin K epoxide reductase complex 1 (VKORC 1) in different individuals. S-Warfarin, the major active isomer of Warfarin is metabolized by CYP2C9 in vivo. Patients with CYP2C9 * 2 (430C> T) and CYP2C9 * 3 (1075A> C) require low stable dose compared to CYP2C9 * 1 wild type, and to achieve a stable dose takes long. At the same time, the INR (International Normalized Ratio) value is too high and the risk of severe bleeding time is significantly higher than that of wild-type patients.
VKORC 1 is a rate limiting enzyme that produces vitamin K dependent coagulation factor in vivo. Warfarin can competitively inhibit the action of this enzyme to achieve the anticoagulation effect. The gene polymorphism of VKORC 1 (-1639G > A) promoter is the most important factor influencing individual Coumadin anticoagulant dose. VGORC1 promoter activity increases in GG genotype individuals, resulting in an increased expression of VKORC 1 mRNA. Increased enzyme levels result in an increased production of vitamin K hydroquinone and coagulation factor generation, therefore require higher doses to achieve anticoagulant effect; While the promoter region -1639 mutation can cause VKORC1 mRNA expression to decrease, so that the production of enzyme in the liver is correspondingly reduced, thereby causing epoxidation of vitamin K reduced to hydroquinone by vitamin K. At this stage, only need small dose to reach the anticoagulant effect, excess will lead to serious side effects such as hemolysis.
In 2013 the "New England Journal of Medicine” published a clinical research guiding medication with Warfarin gene, led in 455 patients randomly divided into Genotype-guided group (gene treatment group) 227 patients and Control group (control group) 228 patients. Among them, the Genotype-guided group was treated according to the patient's genotype [CYP2C9 * 2 (430C> T), CYP2C9 * 3 (1075A> C) and VKORC 1 (-1639G> A). Control group is the conventional treatment group.
Time in Therapeutic Range (TTR):Figure A shows that the INR value of the gene therapy group was lower than that of the control group for three consecutive months. Figure B shows that in the 3 consecutive months, Time in Therapeutic Range (TTR), the percentage of target INR achieved during oral Warfarin, was significantly better in the gene therapy group than in the control group. Figure B shows that the percentage of target INR achieved during the three consecutive months’ Time in Therapeutic Range (TTR), orally administered Warfarin gene therapy was significantly better than in the control group. Figures A and B illustrate that gene therapy is significantly better than that of the conventional dosing regimen.
Product Introduction:Objective: To qualitatively detect the polymorphism of VKORC1 gene -1639 locus (G > A), CYP2C9 gene 430 locus (C > T) and 1075 locus (A > C) in EDTA anticoagulant vein whole blood samples, so as to guide Warfarin personalized medication
Storage and Stability:Store powder at 4°C liquid at -20°C. Store other components at 4°C. Stable for 6 months after receipt. For maximum recovery of product, centrifuge the original vial after thawing and prior to removing the cap.
