Immunoassay with recombinant Trypanosoma cruzi antigens potentially useful for screening donated blood and diagnosing Chagas disease.

A new enzyme immunoassay (EIA), the Dia Kit Bio-Chagas assay (Gador S.A.), is potentially useful for detecting antibodies to Trypanosoma cruzi in the diagnosis of infected individuals and the screening of blood in blood banks. The EIA is carried out on test strips of plastic backing covered with a nitrocellulose membrane to which a mixture of recombinant T. cruzi antigens 1, 2, shed acute-phase antigen, 13, and 30 has been applied as a horizontal line. A horizontal line of human IgG is included to monitor the test procedure. The test strips exhibited homogeneity in the adsorption of the mixture of recombinant antigens (CV = 6.0%) and the human IgG (CV = 8.6%). The EIA results obtained with sera positive by xenodiagnosis showed 100% agreement between both types of tests; tested against sera with positive and negative matched results of indirect hemagglutination, immunofluorescence, and ELISA, the EIA results agreed for 99.1% (347 of 350) and 99.6% (299 of 300) of the samples, respectively.