HLA-B1502 PCR Assay
The Viennalab HLA-B1502 RealFast Assay determines the presence or absence of the HLA-B*15:02 allele in a human genomic DNA extract by real-time PCR. The allele is strongly associated with carbamazepine-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Carbamazepine is prescribed for epilepsy, bipolar disorder and neuropathic pain. The carrier frequency of HLA-B*15:02 is highest in South and Southeast Asian populations. The FDA and the CPIC guideline for carbamazepine recommend testing before treatment is started, so that an alternative drug can be chosen for carriers.
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This kit in detail
- Detects the HLA-B*15: 02 allele
- Screening before carbamazepine treatment, per FDA and CPIC
- Qualitative result: allele present or absent
- Real-time PCR with allele-specific probes
- Whole peripheral blood, dried blood spots, buccal swabs or saliva
- 32 or 100 reactions per kit, REF 7-633 and REF 7-630
The Viennalab HLA-B1502 RealFast Assay discriminates the presence or absence of the HLA-B*15:02 allele in a human genomic DNA extract, as a risk assessment before carbamazepine is prescribed.
Clinical background
Carbamazepine is used for epilepsy, bipolar disorder and neuropathic pain. In a small proportion of patients it causes a severe cutaneous adverse reaction: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilia and systemic symptoms (DRESS). HLA-B*15:02 is strongly associated with the SJS and TEN forms. The carrier frequency is highest in South and Southeast Asian populations, which is where the association was first described.
Application
The FDA label for carbamazepine and the CPIC guideline both recommend determining the HLA-B*15:02 status before the drug is started in patients with ancestry from an at-risk population, and choosing an alternative drug for carriers. A separate RealFast assay covers HLA-A*31:01, the allele associated with a wider spectrum of carbamazepine hypersensitivity.
Method
The assay uses real-time PCR with the RealFast 2x Genotyping Mix and the HLA-B1502 Assay Mix. A positive and a negative control are supplied. DNA isolated from whole peripheral blood, dried blood spots, buccal swabs or saliva can be used, and DNA extraction reagents are not supplied with the kit; ViennaLab recommends the Spin Micro DNA Extraction Kit (REF 2-020), ordered separately.
- RealFast 2x Genotyping Mix (white cap, 1000 / 320 µl)
- HLA-B1502 Assay Mix (purple cap, 550 µl)
- HLA-B1502 Positive Control (green cap, 75 µl)
- HLA-B1502 Negative Control (red cap, 75 µl)
REF 7-630 (100 reactions) and REF 7-633 (32 reactions). 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.
Product Notes
Instructions for Use
Frequently paired with this kit
Other assays and instruments lab teams add alongside the HLA-B1502 PCR Assay.
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