External quality assessment of HLA-B*5701 reporting: an international multicentre survey.

Hammond E, Almeida CA, Mamotte C, Nolan D, Phillips E, Schollaardt TA, Gill MJ, Angel JB, Neurath D, Li J, Giulivi T, McIntyre C, Koultchitski G, Wong B, Reis M, Rachlis A, Cole DE, Chew CB, Neifer S, Lalonde R, Roger M, Jeanneau A, Mallal S
Antivir Ther. 2007 12 (7): 1027-32

PMID: 18018760

OBJECTIVES - 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.

DESIGN AND 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.

MeSH Terms (13)

Alleles Anti-HIV Agents Dideoxynucleosides DNA Primers DNA Probes, HLA Drug Hypersensitivity Genetic Testing HLA-B Antigens Humans Polymerase Chain Reaction Quality Control Reproducibility of Results Sensitivity and Specificity

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