title: Development of a World Health Organisation International Reference Panel for Anti-HIV.
abstract: In response to a recommendation made by the "World Health Organisation (WHO) Working Group on Reference Preparations for Testing HBsAg, Anti-HCV and Anti-HIV Diagnostic Kits", a reference panel for anti-HIV consisting of plasma samples representing the major groups and subtypes of HIV has been prepared. The panel consists of solvent-detergent treated anti-HIV-positive human plasma samples that have been diluted 1 in 40 in anti-HIV-negative human serum and freeze-dried and the anti-HIV-positive plasma samples were derived from individuals infected with HIV-1 group M subtypes A, B, C and CRF01_AE, HIV-1 group O and HIV-2. Fifteen laboratories from around the world took part in a collaborative study to evaluate the reference panel for anti-HIV and were requested to test the panel in as wide a range of assays as possible. Where appropriate, serial dilutions were performed and samples tested around their end-points to facilitate the comparison of analytical sensitivity between assays. For qualitative assays such as Western blots and rapid assays, the panel was tested undiluted. Results show that the HIV-negative serum sample was negative in all assays (except for a small number of Western blot assays) and that all HIV-positive samples were detected in all assays, with the exception of an anti-HIV-2 EIA that did not detect most HIV-1 samples and a small number of assays that failed to detect the group O sample. Considerable variability was seen in the end-point titres obtained with the various assays. A report on the study was submitted to the WHO Expert Committee on Biological Standardisation (ECBS) and the panel established as the 1st International Reference Panel for Anti-HIV (code 02/210); a unitage was not assigned to the panel members.
authors.affiliation: Division of Retrovirology, National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Herts EN6 3QG, UK. Erin.Wigglesworth@nibsc.hpa.org.uk
authors.forename: Erin
authors.initials: E
authors.lastname: Wigglesworth
authors.forename: Alan
authors.initials: A
authors.lastname: Heath
authors.forename: Harvey
authors.initials: H
authors.lastname: Holmes
mesh_terms: D015488:HIV Antigens / Q000032:analysis* / Q000276:immunology; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000145:classification / Q000276:immunology / Q000302:isolation & purification*; D015498:HIV-2 / Q000145:classification / Q000276:immunology / Q000302:isolation & purification*; D006801:Humans; D007106:Immune Sera / Q000276:immunology*; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D012680:Sensitivity and Specificity; D012703:Serotyping; D014944:World Health Organization
chemical_list: D015488:HIV Antigens; D007106:Immune Sera; D011933:Reagent Kits, Diagnostic