title: Validation of two commercial real-time PCR assays for rapid screening of the HLA-B*57:01 allele in the HIV clinical laboratory.
abstract: The pharmacogenetics approach to screen for the presence of the HLA-B*57:01 allele in HIV-1 infected patients is mandatory to prevent the potential development of hypersensitivity reaction to abacavir treatment. Given the limitations of current genotype methodologies, commercial real-time PCR assays were specifically developed for this purpose, but have not been sufficiently validated and are still not widely used. Here, in the context of the HIV laboratory, we assessed the ability of two commercial kits, the LightSNiP rs2395029 HPC5 assay (TIB Molbiol) and the DuplicαReal-TimeHLA-B*5701 Genotyping kit (Euroclone), to retrospectively detect HLA-B*57:01 positive and negative samples of Israeli HIV-1 infected patients. The LightSNiP rs2395029 HPC5 assay had false-positive results, whereas the DuplicαReal-TimeHLA-B*5701 Genotyping kit was highly accurate and could be readily implemented into clinical practice. It is hoped that this study will facilitate the assessment of additional commercial kits for HLA-B*57:01 detection and expand their use in the clinical laboratory. Such studies can likely help the use of abacavir treatment in HIV-1 infected patients.
authors.affiliation: Laboratory for Viruses and Molecular Biology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel; The Crusaid Kobler AIDS Center, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel. Electronic address: boaza@tlvmc.gov.il.
authors.forename: Boaz
authors.initials: B
authors.lastname: Avidor
authors.affiliation: Laboratory for Viruses and Molecular Biology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel; The Crusaid Kobler AIDS Center, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Shirley
authors.initials: S
authors.lastname: Girshengorn
authors.affiliation: Laboratory for Viruses and Molecular Biology, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel; The Crusaid Kobler AIDS Center, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
authors.forename: Liran
authors.initials: L
authors.lastname: Giladi
authors.affiliation: Tissue Typing Unit, Hadassah Medical Center, Jerusalem, Israel.
authors.forename: Shoshana
authors.initials: S
authors.lastname: Israel
authors.affiliation: Clinical Immunology and Tissue Typing Laboratory, Rambam Medical Center, Haifa, Israel.
authors.forename: Rina
authors.initials: R
authors.lastname: Katz
authors.affiliation: The Crusaid Kobler AIDS Center, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel; Infectious Disease Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
authors.forename: Dan
authors.initials: D
authors.lastname: Turner
mesh_terms: D000328:Adult; D000483:Alleles; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use; D019411:Clinical Laboratory Techniques / Q000379:methods*; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use; D005189:False Positive Reactions; D005838:Genotype; D015658:HIV Infections / Q000175:diagnosis / Q000188:drug therapy*; D015235:HLA-B Antigens / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D000099227:Abacavir
chemical_list: D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D015235:HLA-B Antigens; D011933:Reagent Kits, Diagnostic; D000099227:Abacavir; C103707:HLA-B57 antigen
keywords: Abacavir hypersensitivity; HIV laboratory; HIV-1; HLA-B*57:01 screening; Real-time PCR