CYP2D6 Stripassay
The Viennalab PGX-CYP2D6 XL StripAssay determines the CYP2D6 genotype from EDTA blood DNA. CYP2D6 is involved in the metabolism of approximately 25 per cent of drugs used in the clinic, including tamoxifen, opiates, antidepressants and antipsychotics. The assay covers 19 polymorphic loci, corresponding to the alleles *1, *2, *3, *8, *9, *10, *11, *12, *14, *15, *17, *29, *35, *39, *40, *41, *58 and *114. Gene deletions and duplications are not covered by the strip; for copy number the assay is combined with the CYP2D6 CNV RealFast Assay. Together the two give the full metaboliser status.
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This kit in detail
- 19 polymorphic loci, corresponding to the alleles *1, *2, *3, *8, *9, *10, *11, *12, *14, *15, *17, *29, *35, *39, *40, *41, *58 and *114
- Determines poor, intermediate and ultrarapid metaboliser status
- CYP2D6 metabolises approximately 25 per cent of clinically used drugs
- Deletions and duplications require the CYP2D6 CNV RealFast Assay
- PCR and reverse hybridisation on a test strip, with colour reaction
- EDTA blood DNA, 20 tests per kit
The Viennalab PGX-CYP2D6 XL StripAssay determines the CYP2D6 genotype in order to guide the choice and the dose of drugs metabolised by this enzyme.
Clinical background
CYP2D6 is involved in the metabolism of approximately 25 per cent of drugs used in the clinic, including tamoxifen, opiates, antidepressants and antipsychotics. Loss-of-function, reduced-function and increased-function alleles together account for a large part of the variation in drug response between patients.
Alleles covered
The assay covers 19 polymorphic loci in the CYP2D6 gene, corresponding to the alleles *1, *2, *3, *8, *9, *10, *11, *12, *14, *15, *17, *29, *35, *39, *40, *41, *58 and *114. Deletion and duplication of the whole gene are not detected on the strip; for copy number the assay is combined with the CYP2D6 CNV RealFast Assay, which identifies deletions and duplications. The two assays together give the complete metaboliser status.
Metaboliser status
Approximately 6 per cent of Europeans are poor metabolisers, 7 per cent intermediate metabolisers and 3 per cent ultrarapid metabolisers. Clinical guidelines for the drugs concerned are listed in PharmGKB.
Method
The assay uses PCR amplification followed by reverse hybridisation to probes immobilised on a test strip. Biotin-labelled products bind to the strip, streptavidin conjugated to horseradish peroxidase is added, and a chromogenic substrate produces a visible colour reaction. DNA from EDTA blood is used. DNA extraction reagents are not supplied with the kit; ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), ordered separately. One kit covers 20 tests.
- Amplification Mix A (yellow cap, 500 µl)
- Amplification Mix B (green cap, 500 µl)
- Taq Dilution Buffer (transparent cap, 500 µl)
- HS-Taq DNA Polymerase (5 U/µl, red cap, 125 U)
- 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 4-770. DNA extraction reagents are not supplied with the kit. ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), which is 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 CYP2D6 Stripassay.
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