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1994-10-25
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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).