LAMP Human CYP2C19 Deficiency KIT

The LAMP Human CYP2C19 deficiency KIT is an in vitro diagnostic test intended for the qualitative detection of three less functional CYP2C19 alleles (*2, *3, *17) by Loop-mediated isothermal amplification (LAMP) on EDTA whole blood and extracted DNA.

This assay is dedicated to professional use in diagnostic laboratories. The device is not for self-testing.

Regulatory Status: CE-IVD

Format: 24 reactions

Target gene: CYP2C19

Drug relevance: Antiplatelet drug, clopidogrel, mavacamten

Variants detected: CYP2C19*2, CYP2C19*3, CYP2C19*17

Method: LAMP + meting curve analysis

Sample: EDTA whole blood - no DNA extraction required - or extracted DNA

Compatible instruments: LightCycler 480 I&II / Cobas z 480 (Roche); QuantStudio 1/3/5 & 6/7 Flex (Applied Biosystems); MIC qPCR (Bio Molecular Systems); LC-Genie III & Genie HT (Optigene)

Software / result interpretation: Automated genotype calling via GeneFox software; mandatory visual confirmation of the melting curve

Turn around time: < 1h

General information

Advantages

Fast

No DNA extraction

Compatible with a variety of qPCR machines

Automatic interpretation of the results

Related kits and platforms

CYP2C9

The LAMP Human CYP2C9 deficiency KIT is an in vitro diagnostic test intended for the qualitative detection of two less functional CYP2C9 alleles (*2, *3) by Loop-mediated isothermal amplification (LAMP) on EDTA whole blood and extracted DNA.

DPD defeciency

Dihydropyrimidine dehydrogenase (DPD) is an essential enzyme for the metabolism of fluorouracil and capecitabine, two common chemotherapy drugs.

GeneFox

Software that helps to interpret the results of LaCAR GPD and pharmacogenetics assays and generates standardised reports.

The LC-CYP2C19-LP kit uses loop mediated isothermal amplification, a robust amplification method using four to six primers per target, that can be directly used on EDTA whole blood samples, without DNA purification and on extracted DNA samples from whole blood samples.

The genotyping is performed by melting curve analysis after amplification, using a specific probe and quencher for each target polymorphisms.
Testing can be performed on a large set of real-time PCR instruments and LAMP instruments, described underneath.

Test principle

The CYP2C19 enzyme plays a role in the processing or metabolizing of at least 10% of commonly prescribed drugs, including clopidogrel, an antiplatelet drug. CYP2C19 enzyme converts clopidogrel (an inactive prodrug) to its active form, which is necessary for the drug to function in the body. CYP2C19 is also involved in the metabolism of antidepressant such as amitriptyline, moclobemide, citalopram and escitalopram. The gene encoding CYP2C19 is highly polymorphic and these genetic variations can influence individual responses to medications.