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Journal of Clinical Microbiology, January 2009, p. 164-167, Vol. 47, No. 1
0095-1137/09/$08.00+0     doi:10.1128/JCM.01435-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.

Evaluation of the Vitros ECiQ Immunodiagnostic System for Detection of Anti-Toxoplasma Immunoglobulin G and Immunoglobulin M Antibodies for Confirmatory Testing for Acute Toxoplasma gondii Infection in Pregnant Women{triangledown}

David C. Kasper,1,2* Andrea R. Prusa,1 Michael Hayde,1 Nicole Gerstl,1 Arnold Pollak,1 Kurt R. Herkner,1,2 and Rosmarie Reiter-Reisacher3

Department of Pediatrics and Adolescent Medicine,1 Research Core Unit (RCU) of Pediatric Biochemistry and Analytics, Medical University of Vienna,2 Assista Laborelectronics GmbH, Vienna, Austria3

Received 26 July 2008/ Returned for modification 17 September 2008/ Accepted 29 October 2008

Infection with Toxoplasma gondii is often asymptomatic and, when acquired during pregnancy, may lead to connatal toxoplasmosis in the offspring. The newly introduced Vitros anti-Toxoplasma immunoglobulin G (IgG) and IgM assays, designed for the Vitros ECiQ immunodiagnostic system, a fully automated system based on chemiluminescence, were evaluated as a screening method for the serological detection of acute and chronic Toxoplasma infections in the sera of 719 pregnant women. The combination of the Vitros IgG and IgM assays demonstrated a sensitivity and a specificity of 100% for the successful detection of all acute T. gondii infections by comparison with the Sabin-Feldman dye test as the reference test. The Vitros IgG assay parameter revealed a sensitivity of 95.0%, a specificity of 100.0%, a positive predictive value of 100.0%, a negative predictive value of 86.2%, and an overall agreement of 96.2% by comparison with the dye test. Comparison of the Vitros Toxoplasma IgM assay with the immunosorbent agglutination assay yielded values of 77.1%, 99.0%, 97.7%, 88.5%, and 91.1%, respectively. Subsequent receiver operating characteristic curve analysis for the accurate detection of Toxoplasma IgM in acute (n = 90) and chronic (n = 461) infections demonstrated high sensitivity (92.2%) and specificity (81.6%). The combination of a Toxoplasma-specific IgG assay with specific IgM antibody detection has improved the diagnosis of T. gondii infection by decreasing follow-up testing. Nonetheless, positive Toxoplasma IgM test results during pregnancy necessitate confirmatory testing by a reference laboratory to ensure fast and, above all, accurate test results.

* Corresponding author. Mailing address: Medical University of Vienna, Department of Pediatrics and Adolescent Medicine, Währinger Gürtel 18-20, A-1090 Vienna, Austria. Phone: 43 1 40400-2756. Fax: 43 1 40400-3200. E-mail: david.kasper{at}meduniwien.ac.at

{triangledown} Published ahead of print on 5 November 2008.

Journal of Clinical Microbiology, January 2009, p. 164-167, Vol. 47, No. 1
0095-1137/09/$08.00+0     doi:10.1128/JCM.01435-08
Copyright © 2009, American Society for Microbiology. All Rights Reserved.





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