HLA-A3101 PCR Assay
The Viennalab HLA-A3101 RealFast Assay determines the presence or absence of the HLA-A*31:01 allele in a human genomic DNA extract by real-time PCR. The allele is associated with carbamazepine-induced hypersensitivity, including drug reaction with eosinophilia and systemic symptoms (DRESS) as well as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Carbamazepine is prescribed for epilepsy, bipolar disorder and neuropathic pain. HLA-A*31:01 is found across a wide range of populations, including European and Japanese, and covers a broader spectrum of hypersensitivity reactions than HLA-B*15:02. Testing before treatment is started identifies the patients for whom an alternative drug can be chosen.
Quote-based, no public pricing. Add to your quote and our specialists put together a proposal with the right documentation, typically within 24 hours.
This kit in detail
- Detects the HLA-A*31: 01 allele
- Screening before carbamazepine treatment
- 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 7-643 and REF 7-640
The Viennalab HLA-A3101 RealFast Assay discriminates the presence or absence of the HLA-A*31:01 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: drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). HLA-A*31:01 is associated with a broader spectrum of these reactions than HLA-B*15:02, and the association has been described in European and Japanese populations as well as in others.
Application
The CPIC guideline for carbamazepine includes HLA-A*31:01 alongside HLA-B*15:02, and advises against starting the drug in carriers who have not been treated with it before. A separate RealFast assay covers HLA-B*15:02, the allele associated with SJS and TEN in South and Southeast Asian populations.
Method
The assay uses real-time PCR with the RealFast 2x Genotyping Mix and the HLA-A3101 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-A3101 Assay Mix (purple cap, 550 µl)
- HLA-A3101 Positive Control (green cap, 75 µl)
- HLA-A3101 Negative Control (red cap, 75 µl)
REF 7-640 (100 reactions) and REF 7-643 (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-A3101 PCR Assay.
Add this kit to your quote
Tell us the platforms and throughput you’re planning for and our specialists will put together a clear proposal with the right documentation, no public pricing, just a considered answer.
