CYP2C19 StripAssay
The Viennalab CYP2C19 StripAssay determines the CYP2C19 genotype from whole blood or saliva. CYP2C19 metabolises a range of drugs, and variants in the gene reduce or increase the activity of the cytochrome P450 isoenzyme CYP2C19. Genotyping identifies poor metabolisers, for whom dose adjustment prevents adverse events, and rapid metabolisers, for whom a standard dose can result in therapy failure. The assay covers the clinically relevant alleles: the loss-of-function alleles *2 to *8 and the gain-of-function allele *17.
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This kit in detail
- Loss-of-function alleles *2 to *8 and gain-of-function allele *17
- Poor metabolisers: reduced conversion, dose adjustment indicated
- Rapid metabolisers: risk of therapy failure at a standard dose
- Reverse hybridisation on a test strip
- Whole blood, with lysis solution and resin included
- 20 tests per kit
The Viennalab CYP2C19 StripAssay determines the CYP2C19 genotype in order to guide drug dosing. The cytochrome P450 isoenzyme CYP2C19 metabolises a range of drugs, and genetic variants raise or lower its activity. The result supports dose adjustment and reduces the risk of toxicity, adverse drug reactions and impaired efficacy.
Metaboliser phenotypes
In poor metabolisers, drugs metabolised by CYP2C19 are converted more slowly, so the dose has to be adjusted to prevent adverse events. In rapid metabolisers, a standard dose may not reach the target concentration, which can lead to therapy failure.
Alleles covered
The assay covers the clinically relevant alleles: the loss-of-function alleles *2 to *8 and the gain-of-function allele *17. Clinical guidelines for the corresponding drugs are listed in PharmGKB.
Method
The assay uses PCR amplification followed by reverse hybridisation to probes immobilised on a test strip, with a colour reaction for detection. The kit contains the lysis solution and GENXTRACT resin for releasing DNA from whole blood; further DNA extraction reagents are not supplied with the kit; ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), ordered separately.
Variants covered
The strip covers c.681G>A (*2), c.636G>A (*3), c.1A>G (*4), c.1297C>T (*5), c.395G>A (*6), c.819+2T>A (*7), c.358T>C (*8) and c.-806C>T (*17).
- Lysis Solution (50 ml)
- GENXTRACT Resin (5 ml)
- Amplification Mix (yellow cap, 500 µl)
- Taq Dilution Buffer (transparent cap, 500 µl)
- DNAT (blue cap, 1.5 ml)
- Typing Trays (3)
- Teststrips (20)
- Hybridization Buffer (white cap, 25 ml)
- Wash Solution A (white cap, 80 ml)
- Conjugate Solution (25 ml)
- Wash Solution B (80 ml)
- Color Developer (25 ml)
- Instructions For Use (1)
- Collector Sheet (1)
Kit for 20 tests, REF 4-750. DNA extraction reagents are not supplied with the kit. ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020) or the GENxTRACT Blood DNA Extraction System (REF 2-014), which are ordered separately.
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Instructions for Use
Frequently paired with this kit
Other assays and instruments lab teams add alongside the CYP2C19 StripAssay.
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