title: Evaluation of the Abbott ARCHITECT Toxo IgM assay.
abstract: Development of the ARCHITECT Toxo IgM assay has been done to assist the clinician in acute Toxoplasma gondii infection detection, especially in pregnant women. Its use, in conjunction with ARCHITECT Toxo IgG and Toxo Avidity assays, will provide an array of assays particularly useful in the monitoring of pregnant females to determine the risk of maternal transmission of the parasite. Specificity results from 2 testing sites, using populations of pregnant females, hospital patients, and blood donors, demonstrated that the assay has an overall resolved relative specificity of 99.89% (confidence interval, 99.68-99.98%). Relative specificity for pregnant female specimens was 99.95% (n = 2031). Excellent seroconversion sensitivity was observed for the ARCHITECT Toxo IgM assay, which was similar to the Abbott AxSYM Toxo IgM assay (Abbott Laboratories, Abbott Park, IL). In more than 90% of the panels tested, the 1st bleed detected in the serial bleeds was the same for both assays.
authors.affiliation: Abbott GmbH & Co. KG, Wiesbaden-Delkenheim, Germany.
authors.forename: Eva
authors.initials: E
authors.lastname: Sickinger
authors.forename: Hans-Bertram
authors.initials: HB
authors.lastname: Braun
authors.forename: Gerald
authors.initials: G
authors.lastname: Praast
authors.forename: Myriam
authors.initials: M
authors.lastname: Stieler
authors.forename: Cordelia
authors.initials: C
authors.lastname: Gundlach
authors.forename: Claudia
authors.initials: C
authors.lastname: Birkenbach
authors.forename: John
authors.initials: J
authors.lastname: Prostko
authors.forename: Mary Ann
authors.initials: MA
authors.lastname: Palafox
authors.forename: Edwin
authors.initials: E
authors.lastname: Frias
authors.forename: Stephen
authors.initials: S
authors.lastname: Hsu
authors.forename: Matthew
authors.initials: M
authors.lastname: Matias
authors.forename: Dominick
authors.initials: D
authors.lastname: Pucci
authors.forename: Michael
authors.initials: M
authors.lastname: Hausmann
authors.forename: Ulrich
authors.initials: U
authors.lastname: Sagel
authors.forename: Darwin
authors.initials: D
authors.lastname: Smith
mesh_terms: D000818:Animals; D005260:Female; D006801:Humans; D007118:Immunoassay / Q000379:methods; D007075:Immunoglobulin M / Q000097:blood*; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014122:Toxoplasma / Q000276:immunology*; D014123:Toxoplasmosis / Q000175:diagnosis*
chemical_list: D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic