HLA-B5701 PCR Assay
The Viennalab HLA-B5701 RealFast Assay determines the presence or absence of the HLA-B*57:01 allele in a human genomic DNA extract by real-time PCR. The allele is strongly associated with hypersensitivity to abacavir, and carriers must not be treated with the drug. Abacavir is used in combination therapy for HIV-1 infection. A hypersensitivity reaction appears in the first weeks of treatment, with rash, fever, gastrointestinal and respiratory symptoms; re-exposure after an initial reaction can be life-threatening. Testing before the first dose identifies the patients for whom another antiretroviral drug has to be chosen.
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This kit in detail
- Detects the HLA-B*57: 01 allele
- Screening before abacavir treatment
- No cross-reaction with HLA-B*57: 02 or HLA-B*57:03
- Real-time PCR with allele-specific probes
- Whole peripheral blood, dried blood spots, buccal swabs or saliva
- 32 or 100 reactions per kit, REF 7-613 and REF 7-610
The Viennalab HLA-B5701 RealFast Assay discriminates the presence or absence of the HLA-B*57:01 allele in a human genomic DNA extract, as a risk assessment before abacavir is prescribed.
Clinical background
Abacavir is a nucleoside reverse transcriptase inhibitor used in combination therapy for HIV-1 infection. In roughly 5% to 8% of treated patients of European ancestry it causes a hypersensitivity reaction, usually within the first six weeks, with rash, fever, gastrointestinal complaints and respiratory symptoms. The reaction is closely linked to HLA-B*57:01. If it is not recognised, re-exposure to the drug can be life-threatening, so carriers are excluded from abacavir therapy.
Application
Testing for HLA-B*57:01 before the first dose is recommended in the treatment guidelines for HIV-1 and identifies the patients for whom another antiretroviral drug has to be chosen. The assay is designed not to cross-react with the related alleles HLA-B*57:02 and HLA-B*57:03, so a positive result is specific for HLA-B*57:01.
Method
The assay uses real-time PCR with the RealFast 2x Genotyping Mix and the HLA-B5701 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-B5701 Assay Mix (purple cap, 550 µl)
- HLA-B5701 Positive Control (green cap, 75 µl)
- HLA-B5701 Negative Control (red cap, 75 µl)
REF 7-610 (100 reactions) and REF 7-613 (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-B5701 PCR Assay.
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