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Multicenter evaluation of a new commercial assay for detection of immunoglobulin M antibodies toToxoplasma gondii

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Abstract

A new commercial assay for detection of IgM-specific antibodies toToxoplasma 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 suspectedToxoplasma 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 toToxoplasma gondii in human serum and plasma.

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Authors and Affiliations

  1. Clinique Saint-Pierre & Université Catholique de Louvain, Avenue Reine Fabiola 9, B-1340, Ottignies-Louvain-La-Neuve, Belgium

    V. Luyasu & A. R. Robert

  2. Abbott Diagnostics Division, Abbott Park, Illinois, USA

    L. Schaefer & J. Macioszek

Authors
  1. V. Luyasu
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  2. A. R. Robert
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  3. L. Schaefer
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  4. J. Macioszek
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Consortia

Multicenter Study Group

Additional information

M.C. Chretien, Abbott Diagnostics Division, Rungis, France; A. Vockel, Abbott GmbH, Delkenheim, Germany; M.H. Bessieres, Centre Hospitalier Universitaire Rangueil, Toulouse, France; B. Cimon, Centre Hospitalier Régional d'Angers, Angers, France; J. Dyke, Sparrow Hospital, Lansing, Michigan, USA; B. England and M. Canavaggio, Abbott Diagnostics Division, Abbott Park, Illinois, USA; R. Gipson, St. Joseph Hospital & Health Care Center, Tacoma, Washington, USA; A. Goullier, Centre Hospitalier Régional Universitaire, Grenoble, France; K. Janitschke, Robert Koch Institut, Berlin, Germany; O. Morin, Institut de Biologie, Nantes, France; F. Parri, Ospedale Careggi, Firenze, Italy; L. Perrin, Hôpital Cantonnal Universitaire, Geneva, Switzerland; I. Reiter-Owona and H.M. Seitz, Institut für Medizinische Parasitologie, Bonn, Germany; W. Smilovici, Centre de Transfusion, Toulouse, France; P. Thulliez, Institut de Puériculture, Paris, France; J. Zufferey, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.

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Luyasu, V., Robert, A.R., Schaefer, L. et al. Multicenter evaluation of a new commercial assay for detection of immunoglobulin M antibodies toToxoplasma gondii . Eur. J. Clin. Microbiol. Infect. Dis. 14, 787–793 (1995). https://doi.org/10.1007/BF01690994

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