HLA-B*58:01 PCR Kit
Lyophilized real-time PCR assay for qualitative detection of the HLA-B*58:01 allele, a pharmacogenetic marker associated with an increased risk of severe cutaneous adverse reactions to allopurinol.
Ambient shipping and storage 
Single reaction wells format
High accuracy and sensitivity 
Automation-ready Product Description
The Hola HLA-B*58:01 Lyo PCR Kit is a lyophilized real-time SSP-PCR assay under development for qualitative detection of the human HLA-B*58:01 allele from DNA extracted from peripheral blood specimens.
HLA-B*58:01 is an important pharmacogenetic marker associated with an increased risk of severe cutaneous adverse reactions to allopurinol. Allopurinol is widely used as a urate-lowering therapy in patients with gout and hyperuricemia.
Detection of the HLA-B*58:01 allele may support pharmacogenetic research and the evaluation of genetic susceptibility to allopurinol hypersensitivity. The presence of the allele indicates an increased genetic risk but does not predict with certainty that a reaction will occur.
The kit is being developed in a single-reaction lyophilized PCR strip format for selected open qPCR instruments and the Hola MDX01 and Hola MDX08 Systems, enabling laboratories to choose between a manual PCR workflow and an automated Hola MDX workflow.
Technical Specifications
- Product status: In development
- Target: Human HLA-B*58:01 allele
- Application area: Pharmacogenetics and allopurinol hypersensitivity research
- Technology: Real-time SSP-PCR-based design
- Sample type: Blood / DNA extracted from blood
- Reaction format: Single-reaction well format in PCR strip
- Compatible instruments: Bio-Rad CFX96 / CFX Opus, Hola MDX01, Hola MDX08
- Storage and transport: +2 °C to +40 °C
- Intended use: Research use only
Each Kit Contains
- Lyophilized MasterMix in pre-aliquoted strip wells
- Lyophilized Positive Control
- Negative Control
Frequently Asked Questions
What is the HLA-B*58:01 PCR Kit used for?
The kit is being developed for qualitative detection of the human HLA-B*58:01 allele in pharmacogenetic and allopurinol hypersensitivity research workflows.
Why is the HLA-B*58:01 allele relevant?
HLA-B*58:01 is associated with an increased risk of severe cutaneous adverse reactions in patients exposed to allopurinol, a medication commonly used as urate-lowering therapy in patients with gout and hyperuricemia.
Does a positive HLA-B*58:01 result mean that a reaction will occur?
No. The presence of HLA-B*58:01 indicates increased genetic susceptibility but does not mean that an adverse reaction will occur with certainty. Similarly, the absence of the allele does not completely eliminate the risk of allopurinol hypersensitivity.
Which sample type is required?
The intended sample type is blood. The PCR workflow is designed for analysis of DNA extracted from blood samples.
Which instruments are compatible?
The kit is being developed for compatibility with Bio-Rad CFX96 / CFX Opus, Hola MDX01, and Hola MDX08 systems.
What format will the kit use?
The kit is being developed in a single-reaction lyophilized PCR strip format with pre-aliquoted MasterMix.
