title: Validation of a rapid test for HLA-B*58:01/57:01 allele screening to detect individuals at risk for drug-induced hypersensitivity.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  The present method is a rapid and robust assay that is appropriate for screening of HLA-B*58:01/*57:01 alleles.
authors.affiliation: ImmunoRheumatology Laboratory, Pathology North - Northern Sydney, St Leonards, Australia.|Sydney Medical School - Northern, University of Sydney, Sydney, Australia.|Department of Allergy & Clinical Immunology, Hanoi Medical University, Hanoi, Vietnam.
authors.forename: Dinh Van
authors.initials: DV
authors.lastname: Nguyen
authors.affiliation: ImmunoRheumatology Laboratory, Pathology North - Northern Sydney, St Leonards, Australia.
authors.forename: Christopher
authors.initials: C
authors.lastname: Vidal
authors.affiliation: ImmunoRheumatology Laboratory, Pathology North - Northern Sydney, St Leonards, Australia.
authors.forename: Jamma
authors.initials: J
authors.lastname: Li
authors.affiliation: ImmunoRheumatology Laboratory, Pathology North - Northern Sydney, St Leonards, Australia.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Fulton
authors.affiliation: ImmunoRheumatology Laboratory, Pathology North - Northern Sydney, St Leonards, Australia.|Sydney Medical School - Northern, University of Sydney, Sydney, Australia.
authors.forename: Suran L
authors.initials: SL
authors.lastname: Fernando
mesh_terms: D000483:Alleles; D004342:Drug Hypersensitivity / Q000235:genetics*; D005820:Genetic Testing; D015235:HLA-B Antigens / Q000235:genetics*; D006801:Humans; D012306:Risk; D012680:Sensitivity and Specificity
chemical_list: D015235:HLA-B Antigens; C484830:HLA-B*57:01 antigen; C500126:HLA-B*58:01 antigen
keywords: HLA-B*57:01; HLA-B*58:01; SCARs; abacavir; allopurinol; hypersensitivity reaction; pharmacogenomics test; real-time PCR