Document 2688
 DOCN  M94A2688
 TI    WHO comparative evaluation of 21 commercial simple/rapid HIV antibody
       assays.
 DT    9412
 AU    Vercauteren G; Beelaert G; Van Kerckhoven I; van der Groen G; Tamashiro
       H; Institute of Tropical Medicine, Department Infection & Immunity,;
       Antwerpen, Belgium.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):247 (abstract no. PB0419). Unique
       Identifier : AIDSLINE ICA10/94369887
 AB    OBJECTIVE: To evaluate the performance and the major operational aspects
       of 21 simple/rapid (S/R) HIV antibody assays. METHODS: Sera: Assays were
       evaluated on a panel of 537 sera (349 of African, 140 of European and 48
       of South American origins). This panel consisted of 38% HIV-1 and 15.8%
       HIV-2 positive samples. Assays: The assays were performed according to
       the instructions of the manufacturers. The results were interpreted
       independently by three technicians, two out of three readings determined
       the test outcomes. The assay kits were provided free of charge to WHO by
       the manufacturers. The tests were compared to Western blot (WB) HIV-1
       (Dupont) and WB HIV-2 (New Lav blot II, Pasteur) using the WHO WB
       criteria. WB HIV-1 and WB HIV-2 double reactive sera were further
       analyzed by Pepti-Lav 1-2 (Pasteur). RESULTS: The sensitivity of the S/R
       assays (except for Recobead LA Assay (59.8%) and Healthtest HIV-1 Assay
       (58.7%) varied from 94.5% to 100%, the specificity ranged between 75.1%
       (SUDS Murex HIV-1 2b) to 100%. When it takes less than 15 minutes to
       perform a single sample, 12 simple assays can be considered as rapid. A
       S/R assay with visual reading should be easy to read and to interpret,
       this feature is expressed in the interreader variability. The
       interreader variability was < 3% for 6 assays, 3-10% for 7 assays and >
       10% for 8 assays. Other important operational factors of these assays
       will be presented in detail. DISCUSSION AND CONCLUSIONS: The sensitivity
       and specificity of S/R HIV assays evaluated here are not significantly
       different from enzyme immunoassays as described elsewhere. S/R assays
       are suitable for small laboratories and clinics, and in general their
       high prices prohibit their use in many developing countries. WHO has
       attempted to reduce their prices (Global Aids News 1992;1:13). The
       detailed information on the operational characteristics generated from
       this project is available from WHO reports.
 DE    AIDS Serodiagnosis/*METHODS  Comparative Study  Human  HIV
       Antibodies/*BLOOD  HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY
       HIV-1/*IMMUNOLOGY  HIV-2/*IMMUNOLOGY  Quality Control  Sensitivity and
       Specificity  World Health Organization  MEETING ABSTRACT

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).