       Document 0268
 DOCN  M9640268
 TI    Multicenter evaluation of a new commercial assay for detection of
       immunoglobulin M antibodies to Toxoplasma gondii. Multicenter Study
       Group.
 DT    9604
 AU    Luyasu V; Robert AR; Schaefer L; Macioszek J; Clinique Saint-Pierre,
       Ottignies-Louvain-La-Neuve, Belgium.
 SO    Eur J Clin Microbiol Infect Dis. 1995 Sep;14(9):787-93. Unique
       Identifier : AIDSLINE MED/96120947
 AB    A new commercial assay for detection of IgM-specific antibodies to
       Toxoplasma gondii (IMx Toxo IgM, Abbott, USA), based on microparticle
       enzyme immunoassay technology, was evaluated at 15 clinical sites in
       Europe and the USA. Performance characteristics were established by
       testing clinical specimens collected randomly from pregnant women, blood
       donors, individuals with suspected Toxoplasma gondii infection and
       individuals confirmed HIV positive. Reference testing was performed
       using Toxo-M EIA (Abbott). Specimens evaluated at European sites
       yielding discordant results between the new assay and the reference EIA
       were further tested with an immunosorbent agglutination assay; at sites
       in the USA, discordant results were resolved using Platelia Toxo IgM
       (Sanofi, France) and Vidas Toxo IgM (bioMerieux, France) assays. In
       addition, matched plasma and serum, heat-treated and non-heat-treated
       specimens, and fresh and frozen specimens were evaluated at the USA
       sites. At European sites the new commercial assay had a sensitivity of
       95.6% (196/205), a specificity of 99.8% (3,137/3,143) and an agreement
       of 99.6% (3,333/3,348) following resolution of discordant results;
       sensitivity in the USA was 97.4% (184/189), specificity was 99.8%
       (1,204/1,207) and agreement was 99.4% (1,388/1,396) following
       resolution. The new IMx Toxo IgM is a sensitive and specific assay for
       measurement of IgM antibodies to Toxoplasma gondii in human serum and
       plasma.
 DE    Animal  Antibodies, Protozoan/*BLOOD  Female  Human  IgM/*BLOOD
       Pregnancy  Sensitivity and Specificity  Support, Non-U.S. Gov't
       Toxoplasma/*IMMUNOLOGY  JOURNAL ARTICLE  MULTICENTER STUDY

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

