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1994-10-25
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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).