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Journal of Clinical Microbiology, December 2001, p. 4390-4395, Vol. 39, No. 12
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.12.4390-4395.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

Enzyme-Linked Immunosorbent Assay for Serological Diagnosis of Chagas' Disease Employing a Trypanosoma cruzi Recombinant Antigen That Consists of Four Different Peptides

A. W. Ferreira,1,2,* Z. R. Belem,1 E. A. Lemos,1 S. G. Reed,3 and A. Campos-Neto3

Biolab-Mérieux S/A-Sao Paulo1 and Tropical Medicine Institute Sao Paulo,2 Sao Paulo, Brazil, and Corixa Corporation and Infectious Disease Research Institute, Seattle, Washington3

Received 7 May 2001/Returned for modification 12 July 2001/Accepted 17 September 2001

Serological tests to detect Trypanosoma cruzi antibodies have been used for screening blood donors, for epidemic studies, and for diagnosis of probably infected persons. Among different tests, the enzyme-linked immunosorbent assay (ELISA) with total, semipurified, or synthetic antigens has been widely used, mainly due to its easy automation. Aiming to improve serological studies concerning Chagas' disease, we have developed and evaluated a new test, the TcF-ELISA, using an artificially engineered recombinant antigen, which contains tandem sequences of different T. cruzi-specific peptides. The sensibility of the TcF-ELISA was determined with 101 serum samples from chagasic patients well-defined by clinical and epidemiological criteria. The specificity was determined with 39 serum samples from leishmaniasis or kala-azar patients and 150 serum samples from nonchagasic blood donors from Sao Paulo, Brazil. The TcF-ELISA showed 100% sensitivity and 98.94% of specificity. Compared with conventional ELISA (with semipurified T. cruzi epimastigote antigens), the TcF-ELISA showed advantages; for example, it distinguishes better between reagent and nonreagent serum and provides better precision and a lower occurrence of leishmaniasis cross-reactions. Our studies demonstrate high reproducibility between two different lots of the TcF ELISA and its applicability for the serological diagnosis of Chagas' disease.

* Corresponding author. Mailing address: Tropical Medicine Institute, Av. Dr. Eneas de Carvalho Aguiar, 470, CEP 05403-140, São Paulo, Brazil. Phone: 55 11 30850416. Fax: 55 11 30623622. E-mail: clawsmbf{at}usp.br.

Journal of Clinical Microbiology, December 2001, p. 4390-4395, Vol. 39, No. 12
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.12.4390-4395.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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