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

Abstract:

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.

journal_name

Antivir Ther

journal_title

Antiviral therapy

authors

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

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

1027-32

issue

7

eissn

1359-6535

issn

2040-2058

journal_volume

12

pub_type

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