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lüll Novel sensitive, specific and rapid pharmacogenomic test for the prediction of abacavir hypersensitivity reaction: HLA-B*57:01 detection by real-time PCR Dello Russo C; Lisi L; Lofaro A; Di Giambenedetto S; Federico B; Madeddu G; Salerno M; Mura MS; Pirazzoli A; de Luca A; Cauda R; Navarra PPharmacogenomics 2011[Apr]; 12 (4): 567-76AIM: 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 kappa = 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.|Anti-HIV Agents/*adverse effects/therapeutic use[MESH]|Base Sequence[MESH]|Dideoxynucleosides/*adverse effects/therapeutic use[MESH]|Drug Hypersensitivity/blood/*diagnosis/*genetics[MESH]|HIV Infections/drug therapy[MESH]|HLA-B Antigens/blood/*genetics[MESH]|Humans[MESH]|Molecular Sequence Data[MESH]|Pharmacogenetics[MESH]|Polymerase Chain Reaction/*methods[MESH] |