AIM: International HIV treatment guidelines recommend HLA-B*57:01 typing before 
abacavir administration, in order to reduce the incidence of abacavir 
hypersensitivity reactions, the major cause of early therapy discontinuation. A 
fast, sensitive and specific test for HLA-B*57:01 detection has been developed 
in the present study.
MATERIALS & METHODS: Two sets of sequence-specific primers were designed, and 
amplification rapidly detected by real-time PCR.
RESULTS: A total of 108 samples were analyzed in a single-blind fashion, and 41 
samples were identified as positive. Complete agreement, with κ = 1 (standard 
error = 0.0962, p < 0.0001), was found, with a validated methodology used in the 
EPI109367 clinical trial funded by GlaxoSmithKline, and consisting of 
low-resolution sequence-specific oligonucleotide PCR, followed by 
high-resolution sequence-specific oligonucleotide PCR carried out on the 
HLA-B*57-positive samples.
CONCLUSION: We provided a detailed characterization of a novel HLA-B*57:01 
screening test, which can be easily implemented by those laboratories already 
involved in the detection of viral load and virus genotyping. Original submitted 
26 October 2010; Revision submitted 13 December 2010.