Evaluation of the Abbott ARCHITECT Toxo IgM assay.
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.
Sickinger
Eva
E
Abbott GmbH & Co. KG, Wiesbaden-Delkenheim, Germany.
Braun
Hans-Bertram
HB
Praast
Gerald
G
Stieler
Myriam
M
Gundlach
Cordelia
C
Birkenbach
Claudia
C
Prostko
John
J
Palafox
Mary Ann
MA
Frias
Edwin
E
Hsu
Stephen
S
Matias
Matthew
M
Pucci
Dominick
D
Hausmann
Michael
M
Sagel
Ulrich
U
Smith
Darwin
D
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*
D007075:Immunoglobulin M; D011933:Reagent Kits, Diagnostic