Evaluation of the Abbott ARCHITECT Chagas prototype assay.

Serologic tests are established tools for the diagnosis of Chagas disease applied to support a safe blood supply in endemic countries. However, sensitivity and specificity of most commercially available enzyme-linked immunosorbent assays (ELISAs) are not regarded as adequate enough to rely on a single assay to determine the Trypanosoma cruzi infection status of a blood donor or a patient. The overall assay performance is driven by the general choice of antigens and the actual antigen cocktail provided in the test.

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.

Development of fully automated determination of marker-specific immunoglobulin G (IgG) avidity based on the avidity competition assay format: application for Abbott Architect cytomegalovirus and Toxo IgG Avidity assays.

Determination of the avidity of immunoglobulin G (IgG) directed against a specific marker has become an established diagnostic tool for identifying or excluding acute infections with pathogens. A novel assay format termed AVIcomp (avidity competition based on mass action) circumventing the conventional chaotropic format has been developed for determination of the avidity of marker-specific IgG in patient specimens. Its applications for cytomegalovirus (CMV) and Toxoplasma gondii are presented.