gb PHARM CYP2C19
Detection method:
allelic discrimination
This in vitro diagnostic kit is intended for detection of CYP2C19*2, CYP2C19*3 and CYP2C19*17 gene mutation. The detection principle is based on a real-time polymerase chain reaction (qPCR) using fluorescent labeled probes (allelic discrimination).
Clinical implications of the CE IVD kit
CYP2C19 is a clinically relevant enzyme involved in the biotransformation of a range of antidepressant, anticoagulant and antimycotic drugs. Side effects of clopidogrel treatment are associated with severe consequences. Clopidogrel is a very effective antiplatelet drug, the effect of which is based on an irreversible inhibition of platelet receptor P2RY12. It is a pro-drug that is activated by the cytochrome P450 complex, predominantly by the CYP2C19.
Slow metabolizers are the most common carriers of the allele *2 and *3 and ultra-fast metabolism is associated with the allele *17 in the Caucasian population. Slow metabolisers do not produce an active form of the drug and they are in risk of non functional treatment. The ultra-fast metabolisers are in danger of bleeding conditions due to reduced platelet activity.
Parameters of the real-time PCR diagnostic kit
- ready-to-use assay
- sample concentration 2-100 ng/µl
- positive and negative controls included
- FAM and HEX channels detection
- identical amplification profile as gb HEMO, gb GENETIC, gb PHARM kits
Validated for:
ABI 7500/7500 Fast (ABI)
CFX96/96Touch (Bio-Rad)
Light Cycler 480/Cobas z480 (Roche Diagnostics)
QuantStudio 5 (Applied Biosystems)
RG 3000 (Corbett Research)
RG 6000/Q (Corbett Research/Qiagen)