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M9650445.TXT
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1996-03-09
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Document 0445
DOCN M9650445
TI Multicentre study for diagnostic evaluation of an assay for simultaneous
detection of antibodies to HIV-1, HIV-2 and HIV-1 subtype 0 (HIV-0).
DT 9605
AU Bachmann P; Beyer J; Brust S; Engelhardt W; Gurtler LG; Habermehl KO;
Karakassopoulos A; Michl U; Muhlbacher A; Stoffler-Meilicke M; et al;
Swiss Red Cross, Central Laboratory, Bern, Switzerland.
SO Infection. 1995 Sep-Oct;23(5):322-33. Unique Identifier : AIDSLINE
MED/96128601
AB The aim of the study was to evaluate a new ELISA for detection of HIV-1,
HIV-2 and HIV-1 subtype 0 (HIV-0) antibodies. The assay format is based
on the antigen sandwich principle. To enable specific detection of HIV-0
antibodies, in addition to HIV-1 and HIV-2 antigens HIV-0 antigen is
used for coating the solid phase and for the conjugate. The results show
that all 12 HIV-0 samples tested were detected with a high degree of
reactivity, as were all the 1,144 anti-HIV-1 and 424 anti-HIV-2 positive
samples. The capacity of the test to enable early detection of
seroconversions is equivalent to that of other sandwich ELISAs. The
specificity of the assay was determined to be 99.89/99.94%
(initial/after retest) using 58,366 samples, which is superior to the
other ELISAs used for comparison. Even with difficult samples (i.e.
samples of African origin, samples known to cause false-positive
reactivity in different ELISAs, or samples containing potential
interference factors) there were very few false-positive reactions.
Therefore, the new assay is well suited for screening blood donations as
well as for evaluating samples from patients of different geographic
origin.
DE Comparative Study Enzyme-Linked Immunosorbent Assay/*METHODS
Evaluation Studies Human HIV Antibodies/*BLOOD HIV
Seropositivity/*DIAGNOSIS HIV-1/*IMMUNOLOGY HIV-2/*IMMUNOLOGY
Predictive Value of Tests Reagent Kits, Diagnostic Sensitivity and
Specificity JOURNAL ARTICLE MULTICENTER STUDY
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).