title: External quality assessment of HLA-B*5701 reporting: an international multicentre survey.
abstract: OBJECTIVE
  HLA-B*5701 strongly predicts abacavir hypersensitivity (HSR), but implementation of effective routine screening into clinical practice requires testing be practical and accurate. We tested the proficiency of HLA-B*5701 typing among laboratories using sequence-specific primer PCR.
  
  
  METHODS
  DNA panels (1 and 2) were distributed to seven laboratories (A to G) for blinded typing of the HLA-B*5701 allele. Panel 1 (n = 10 samples; n = 7 laboratories) included 3 positives and other closely related B17 subtypes (B*5702, B*5703, B*5704 and B*5801). Panel 2 (n = 96 samples; n = 4 laboratories) included 36 positives among a broad spectrum of other B alleles. Two laboratories (A and B) also submitted 96 routine samples, typed by the same methodology, to the reference centre for additional analysis by sequence-based typing.
  
  
  RESULTS
  All laboratories correctly typed panel 1 for HLA-B*5701 carriage. Laboratories A, B and C identified HLA-B*5701 alleles in panel 2 with 100% sensitivity and 100% specificity. Laboratory D reported one false negative, reportedly due to a sampling error. The results obtained for routine samples typed by laboratories A and B and those generated by the reference laboratory using sequencing were fully concordant.
  
  
  CONCLUSIONS
  Detection of HLA-B*5701 alleles among laboratories was 100% specific and 99.4% sensitive, indicating that participating HIV testing laboratories were currently offering effective primary screening to identify individuals at high risk of abacavir HSR. Accurate reporting of HLA-B*5701 status is critical for the safe administration of this drug and participation in quality assurance programmes by all sites who report HLA-B*5701 status should be promoted.
authors.affiliation: Centre for Clinical Immunology and Biomedical Statistics, Royal Perth Hospital and Murdoch University, Western Australia, Australia. E.Hammond@murdoch.edu.au
authors.forename: Emma
authors.initials: E
authors.lastname: Hammond
authors.forename: Coral-Ann
authors.initials: CA
authors.lastname: Almeida
authors.forename: Cyril
authors.initials: C
authors.lastname: Mamotte
authors.forename: David
authors.initials: D
authors.lastname: Nolan
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Phillips
authors.forename: Tineke Asma
authors.initials: TA
authors.lastname: Schollaardt
authors.forename: M John
authors.initials: MJ
authors.lastname: Gill
authors.forename: Jonathan B
authors.initials: JB
authors.lastname: Angel
authors.forename: Doris
authors.initials: D
authors.lastname: Neurath
authors.forename: Jianping
authors.initials: J
authors.lastname: Li
authors.forename: Tony
authors.initials: T
authors.lastname: Giulivi
authors.forename: Cathy
authors.initials: C
authors.lastname: McIntyre
authors.forename: Galina
authors.initials: G
authors.lastname: Koultchitski
authors.forename: Betty
authors.initials: B
authors.lastname: Wong
authors.forename: Marciano
authors.initials: M
authors.lastname: Reis
authors.forename: Anita
authors.initials: A
authors.lastname: Rachlis
authors.forename: David E
authors.initials: DE
authors.lastname: Cole
authors.forename: Choo Beng
authors.initials: CB
authors.lastname: Chew
authors.forename: Stefan
authors.initials: S
authors.lastname: Neifer
authors.forename: Richard
authors.initials: R
authors.lastname: Lalonde
authors.forename: Michel
authors.initials: M
authors.lastname: Roger
authors.forename: Annie
authors.initials: A
authors.lastname: Jeanneau
authors.forename: Simon
authors.initials: S
authors.lastname: Mallal
mesh_terms: D000483:Alleles; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D017931:DNA Primers; D015343:DNA Probes, HLA; D015224:Dideoxynucleosides / Q000009:adverse effects* / Q000627:therapeutic use; D004342:Drug Hypersensitivity / Q000235:genetics; D005820:Genetic Testing / Q000592:standards*; D015235:HLA-B Antigens / Q000235:genetics*; D006801:Humans; D016133:Polymerase Chain Reaction; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D017931:DNA Primers; D015343:DNA Probes, HLA; D015224:Dideoxynucleosides; D015235:HLA-B Antigens; D000099227:Abacavir; C484830:HLA-B*57:01 antigen