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

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