Validation of a rapid test for HLA-B*58:01/57:01 allele screening to detect individuals at risk for drug-induced hypersensitivity

Dinh Van Nguyen; Christopher Vidal; Jamma Li; Richard B Fulton; Suran L Fernando

doi:10.2217/pgs.15.185

Validation of a rapid test for HLA-B*58:01/57:01 allele screening to detect individuals at risk for drug-induced hypersensitivity

Pharmacogenomics. 2016 Apr;17(5):473-80. doi: 10.2217/pgs.15.185. Epub 2016 Mar 30.

Authors

Dinh Van Nguyen^{1

2

3}, Christopher Vidal¹, Jamma Li¹, Richard B Fulton¹, Suran L Fernando^{1

2}

Affiliations

¹ ImmunoRheumatology Laboratory, Pathology North - Northern Sydney, St Leonards, Australia.
² Sydney Medical School - Northern, University of Sydney, Sydney, Australia.
³ Department of Allergy & Clinical Immunology, Hanoi Medical University, Hanoi, Vietnam.

PMID: 27027663
DOI: 10.2217/pgs.15.185

Abstract

Aim: In prevention of allopurinol and abacavir hypersensitivity, screening HLA-B*58:01/57:01 has been highly recommended prior to commencing these therapies. Therefore, we aimed at developing and validating a rapid and robust screening method for HLA-B*58:01/57:01.

Materials & methods: Real-time polymerase chain reaction with TaqMan probes was employed to detect HLA-B*58:01/57:01.

Results: The newly developed assay has the sensitivity of 100% (95% CI: 79.4-100.0%), the specificity of 98.8% (95% CI: 93.6-99.9%), the positive predictive value of 94.1% (95% CI: 71.3-99.9%) and the negative predictive value of 100.0% (95% CI: 95.7-100.0%). The lowest limit of detection is 0.04 ng/µl of DNA.

Conclusion: The present method is a rapid and robust assay that is appropriate for screening of HLA-B*58:01/*57:01 alleles.

Keywords: HLA-B*57:01; HLA-B*58:01; SCARs; abacavir; allopurinol; hypersensitivity reaction; pharmacogenomics test; real-time PCR.

Publication types

Research Support, Non-U.S. Gov't
Validation Study

MeSH terms

Alleles
Drug Hypersensitivity / genetics*
Genetic Testing
HLA-B Antigens / genetics*
Humans
Risk
Sensitivity and Specificity

Substances

HLA-B Antigens
HLA-B*57:01 antigen
HLA-B*58:01 antigen