Document 2719
 DOCN  M94A2719
 TI    A specificity evaluation of a HIV-1/HIV-2 immunoassay on a random access
       automated analyzer.
 DT    9412
 AU    Hall-Steele G; Nehmadi F; Reichert H; Kewin D; Phelps B; Abbott
       Laboratories, Abbott Park, IL.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):240 (abstract no. PB0389). Unique
       Identifier : AIDSLINE ICA10/94369856
 AB    OBJECTIVE: To evaluate an immunoassay for the detection of antibodies to
       HIV-1 and HIV-2 on a random, continuous access analyzer at a Southern
       United States hospital. METHOD: Human sera or plasma samples from
       hospital patients selected at random were incubated with microparticles
       coated with HIV-1 and HIV-2 proteins. Biotinylated HIV-1 and HIV-2
       proteins were then added to form antigen-antibody-antigen complexes.
       Bound antibody was measured by the addition of alkaline phosphatase
       anti-biotin conjugate and a fluorescent substrate. Sample handling,
       assay manipulation and results reporting were continuously performed by
       the random access immunoassay analyzer. RESULTS: Assay sensitivity was
       assessed in preliminary studies using 8 HIV-1 seroconversion panels and
       one HIV-2 sensitivity panel. This assay detected 45 of 61 seroconversion
       panel members as positive compared to 44 of 61 with another licensed
       assay. Both assayed detected an equivalent number of HIV-2 panel members
       as positive. When hospital patient samples were tested, 1 of 837 (0.12%)
       sera and 11 of 1158 (0.95%) plasma samples were initially reactive. The
       1 sera (0.12%) and 10 of the 11 plasma (0.86%) samples were reactive
       again when retested and were confirmed HIV-1 antibody positive by
       Western Blot analysis. The single plasma sample which was negative upon
       retest did not confirm positive for either HIV-1 or HIV-2. CONCLUSION:
       In this study, the sensitivity of this assay for HIV-1 and HIV-2
       antibodies is equivalent to another licensed HIV-1/HIV-2 assay. In
       addition, all repeat reactive samples were confirmed positive by HIV-1
       Western Blot analysis.
 DE    AIDS Serodiagnosis/*INSTRUMENTATION  Blotting, Western  Human  HIV
       Seronegativity/IMMUNOLOGY  HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY
       HIV-1/*IMMUNOLOGY  HIV-2/*IMMUNOLOGY  Immunoassay/*INSTRUMENTATION
       Predictive Value of Tests  MEETING ABSTRACT

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