title: Evaluation of the Roche Elecsys Toxo IgG and IgM electrochemiluminescence immunoassay for the detection of gestational Toxoplasma infection.
abstract: Unidentified gestational infection with Toxoplasma gondii may lead to fetal infection with severe complications later in childhood. Because diagnosis of maternal infection solely depends on serology, routine tests with high sensitivity and specificity are required. In this study, the new Roche Elecsys Toxo IgG and IgM immunoassay was compared with Sabin-Feldman dye test and immunosorbent agglutination assay-IgM as reference test. Serum samples were analyzed from 927 pregnant women, including 100 negative, 706 chronic, and 121 acute infections. The combination of both Elecsys IgG and IgM assays demonstrated high sensitivity and specificity of 97.1% and 100.0%, respectively, and a positive and negative predictive value of 100.0% and 81.3%, respectively. The Elecsys assay is a useful tool as a first-line screening method to detect gestational infections. However, if gestational infection is assumed, confirmatory testing by a reference laboratory might be necessary to discriminate between pre- and postconceptional infection to start antiparasitic treatment to avoid mother-to-fetus transmission and severe sequelae.
authors.affiliation: Department of Paediatrics and Adolescent Medicine, Medical University of Vienna, 1090 Vienna, Austria.
authors.forename: Andrea-Romana
authors.initials: AR
authors.lastname: Prusa
authors.forename: Michael
authors.initials: M
authors.lastname: Hayde
authors.forename: Lukas
authors.initials: L
authors.lastname: Unterasinger
authors.forename: Arnold
authors.initials: A
authors.lastname: Pollak
authors.forename: Kurt R
authors.initials: KR
authors.lastname: Herkner
authors.forename: David C
authors.initials: DC
authors.lastname: Kasper
mesh_terms: D000208:Acute Disease; D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood; D002908:Chronic Disease; D004563:Electrochemistry; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007074:Immunoglobulin G / Q000097:blood*; D007075:Immunoglobulin M / Q000097:blood*; D008163:Luminescent Measurements; D011237:Predictive Value of Tests; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000175:diagnosis* / Q000276:immunology; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014122:Toxoplasma / Q000276:immunology*; D014123:Toxoplasmosis / Q000175:diagnosis* / Q000276:immunology
chemical_list: D000913:Antibodies, Protozoan; D007074:Immunoglobulin G; D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic