Detection method: allelic discrimination

The CE IVD kit is used for determination of genotype of four polymorphisms according to guidelines CPIC and DPWG: *2A (c1905+1G>A), *13 (c1679T>G), HapB3 (c1236G>A) and c2846A>T in human genomic DNA. The principle of detection is based on real-time PCR with fluorescently labelled probes (allelic discrimination).

Clinical implications of the CE IVD kit

Fluoropyrimidines (5-fluorouracil and its prodrugs capecitabine and tegafur) are the basic drugs used in chemotherapy of gastrointestinal cancer. Their use is limited by development of many toxic effects including life-threatening myelosuppression. Dihydropyrimidine dehydrogenase (DPD) catalyzes the initial step of pyrimidines catabolism.

It inactivates fluoropyrimidine chemotherapeutics and its activity influences the frequency of toxicity. It is not recommended to administer the fluoropyrimidines to the patients with DPD deficiency. When studying polymorfisms of the gene for DPD (DPYD), the relationship between presence of particular mutations and decreased activity of DPD has been demonstrated.

According to recommendations of pharmacogenetics consortia CPIC (from 2017) and DPWG (from 20190), the testing of presence of four polymorphisms in DPYD gene: *2A (c1905+1G>A), *13 (c1679T>G), HapB3 (c1236G>A) and c2846A>T is recommended before administration of the above substances. For other polymorphisms have not been gathered enough evidence on their effect on DPD enzyme activity.

Parameters of the real-time PCR diagnostic kit

  • ready-to-use assay
  • input sample concentration 1-100 ng/µl
  • positive controls for each of the genotypes and a negative control included
  • FAM and HEX channels detection
  • identical amplification profile as gb HEMO, gb GENETIC, gb PHARM kits
Cat. No. Product No. of reactions Price
3255-025 gb PHARM DPYD 25
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CE IVD kit contains reagents to provide 25 PCR reactions (20 μl volume of each reaction).

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    General Terms and Conditions

    Validated for:

    CFX Opus 96 (Bio-Rad)

    CFX96/96Touch (Bio-Rad)

    Light Cycler 480/Cobas z480 (Roche Diagnostics)

    QuantStudio 5 (Applied Biosystems)

    RG 3000 (Corbett Research)

    Select further cyclers

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