@article{104135,
  keywords = {Polymerase Chain Reaction (PCR), Human leukocyte antigens, Drug Hypersensitivity, Dapsone, leprosy},
  author = {Rana DR and Koju K and Shakya J and Manandhar S and Singh A and Shah M and Hagge DA and Joshi J},
  title = {A cost-effective conventional endpoint PCR assay for HLA-B*13:01 genotyping to guide personalized dapsone therapy in leprosy in low-resource settings},
  abstract = {<p>Dapsone is a drug used to treat leprosy. Dapsone causes a highly morbid and potentially fatal severe drug hypersensitivity reaction (DHS) in 1–3% of leprosy cases. The allele <strong>HLA-B*13:01</strong> is a known genetic risk factor for DHS. However, resource-intensive genotyping methods preclude its testing in resource-limited settings. This study aimed to develop an endpoint PCR assay to detect the presence of <strong>HLA-B*13:01</strong>.</p>

<h3 id="d1e394">Research design and methods</h3>

<p>DNA was extracted from blood samples of leprosy patients at Anandaban Hospital, Nepal (2022–24). A duplex endpoint PCR was optimized and validated against a previously validated commercial qPCR method and NGS (next‑generation sequencing).</p>

<h3 id="d1e397">Results</h3>

<p>In 113 samples, duplex PCR showed 100% (95% CI: 79.4–100%) sensitivity and 100% specificity (95% CI: 96.2–100%) compared to the validated qPCR method. The same accuracy was confirmed in 58 NGS-typed samples (concordance 98.3%, 95% CI: 90.7–99.9%). The assay reliably differentiated <em>HLA-B</em>*13:01 from closely related allele. Analytical sensitivity reached a lower detection limit of 100 genome equivalents (0.67 ng DNA/reaction).</p>

<h3 id="d1e404">Conclusion</h3>

<p>The developed duplex endpoint PCR offers a simple and affordable method for detecting <em>HLA-B</em>*13:01, suitable in low-resource settings. Its use may significantly reduce the risk of DHS by guiding safer drug choices prior to MDT initiation.</p>
},
  year = {2026},
  journal = {Personalized Medicine},
  volume = {23},
  pages = {329 - 338},
  month = {08/2026},
  publisher = {Informa UK Limited},
  issn = {1741-0541, 1744-828X},
  doi = {10.1080/17410541.2026.2724106},
  language = {ENG},
}