The ability of the Abbott IMx automated analyzer to detect immunoglobulin G (IgG) and IgM antibodies to rubella virus and to Toxoplasma gondii was compared with the abilities of RUBAZYME, RUBAZYME-M, ABBOTT TOXO-G enzyme immunoassay, and ABBOTT TOXO-M enzyme immunoassay, respectively. Specimens that produced discordant results were evaluated by RUBACELL Il, Behring Enzygnost-Rubella enzyme-linked immunosorbent assay, Behring Enzygnost Toxoplasmosis/IgG, and bioMerieux Toxo-ISAGA (immunosorbent agglutination assay), respectively. After resolution of discordant results, IMx Rubella IgG,
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 (bioMérieux, 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.
The Abbott CMV-M enzyme immunoassay (EIA) for the qualitative determination of immunoglobulin M (IgM) antibody to cytomegalovirus in human serum was compared with the indirect fluorescent-antibody (IFA) test on 338 human serum specimens. Discordant specimens were evaluated by IFA following isolation of IgM fractions. Discordant specimens remaining after IFA testing were evaluated by an IgM-specific EIA (CYTOMEGELISA M; M.A. Bioproducts). After resolution of discordant specimens, the CMV-M EIA was 94.7% sensitive and 99.1% specific.
TESTPACK ROTAVIRUS, a simple 10-min enzyme immunoassay, was compared with electron microscopy and Pathfinder enzyme immunoassay on feces from 172 patients of various ages with gastroenteritis. The percent sensitivities and specificities before blocking with antiserum were as follows: TESTPACK, 100% sensitivity and 99% specificity; Pathfinder, 95% sensitivity and 98% specificity. After blocking, the sensitivity and specificity, respectively, were 100% and 100% for TESTPACK and 95% and 99% for Pathfinder. TESTPACK ROTAVIRUS was more sensitive, but not significantly, than Pathfinder (P > 0.1) and the direct electron microscopy technique (P > 0.1).
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