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Research Article

Comparison of Four Chimeric Antigens and Commercial Serological Assays for the Diagnosis of Trypanosoma cruzi Infection

Natália Erdens Maron Freitas Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;

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Denis Augusto Argolo Campos Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;

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Randrin Queiroz Viana Ferreira Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;

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Felipe Silva Santos de Jesus Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;

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Ângelo Antônio Oliveira Silva Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;

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Cristiane Oliveira da Mota Gonçalo Moniz Public Health Central Laboratory (LACEN-BA), Salvador, Brazil;

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Fabricio Klerynton Marchini Molecular Biology Institute of Paraná, Curitiba, Brazil;
Laboratory for Applied Science and Technology in Health, Carlos Chagas Institute, Oswaldo Cruz Foundation (FIOCRUZ-PR), Curitiba, Brazil;

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Paola Alejandra Fiorani Celedon Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Molecular Biology of Trypanosomatids Laboratory, Carlos Chagas Institute, Oswaldo Cruz Foundation (Fiocruz-PR), Curitiba, Brazil;

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Nilson Ivo Tonin Zanchin Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Structural Biology and Protein Engineering Laboratory, Carlos Chagas Institute, Oswaldo Cruz Foundation (Fiocruz-PR), Curitiba, Brazil;
Integrated Translational Program in Chagas Disease from FIOCRUZ (Fio-Chagas), Oswaldo Cruz Foundation (FIOCRUZ-RJ), Rio de Janeiro, Brazil

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Fred Luciano Neves Santos Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil;
Integrated Translational Program in Chagas Disease from FIOCRUZ (Fio-Chagas), Oswaldo Cruz Foundation (FIOCRUZ-RJ), Rio de Janeiro, Brazil

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DOI:
https://doi.org/10.4269/ajtmh.24-0379
Volume/Issue:
Ahead of Print
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Chagas disease (CD), a neglected tropical disease caused by Trypanosoma cruzi, is a significant public health issue particularly in Latin America, affecting millions worldwide. Diagnosis is a challenge owing to the genetic diversity of T. cruzi and the complexities involved in selecting antigens for the detection of anti–T. cruzi antibodies. This study evaluated four chimeric recombinant antigens (IBMP-8.1, IBMP-8.2, IBMP-8.3, and IBMP-8.4) designed to enhance diagnostic accuracy by addressing assay variability. We compared the diagnostic performance of these chimeric antigens using indirect ELISA as a diagnostic platform, with three commercial serological assays in Brazil, analyzing 100 serum samples from individuals with confirmed CD and 86 from non-infected controls. The results revealed that all assays and antigens demonstrated an area under the receiver operating characteristic curve of 100%, signifying their exceptional ability to distinguish between CD-positive and CD-negative samples. Notably, the chimeric antigens achieved 100% sensitivity, specificity, accuracy, and kappa index, equaling or surpassing the commercial assays. This research highlights the efficacy of IBMP chimeric antigens as reliable diagnostic tools for CD, suggesting their potential integration into commercial diagnostic platforms to enhance the accuracy and reliability of CD detection.

Author Notes

Financial support: This research was supported by the Coordination for the Improvement of Higher Education Personnel in Brazil (CAPES; Finance Code 001) and The Bahia Research Foundation (FAPESB). N. I. T. Zanchin and F. L. N. Santos are research grantees of the National Council for Scientific and Technological Development-Brazil (CNPq; grant numbers 304894/2023-0 and 306448/2023-8, respectively). The funders had no influence on the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Disclosures: The study was approved by the Institutional Review Board (IRB) for Human Research at the Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ), Salvador, Bahia, Brazil, under protocol number 67809417.0.0000.0040. All study procedures were conducted in strict accordance with the Declaration of Helsinki and its later amendments, as well as pertinent Brazilian ethical guidelines, specifically Resolutions No. 466/1996 and No. 510/2016. To safeguard patient confidentiality, the IRB mandated that all samples be anonymized to obscure patient identities, eliminating the necessity for verbal or written consent. Prior to the researchers’ access to the human sera samples, all patient data were completely anonymized.

Current contact information: Natália Erdens Maron Freitas, Denis Augusto Argolo Campos, Randrin Queiroz Viana Ferreira, Felipe Silva Santos de Jesus, and Ângelo Antônio Oliveira Silva, Gonçalo Moniz Institute (Fiocruz-BA), Advanced Public Health Laboratory, Salvador, Brazil, and Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil, E-mails: natalia.erdens@fiocruz.br, denis.campos@fiocruz.br, randrin.ferreira@fiocruz.br, felipe.jesus@fiocruz.br, and angelo.oliveira@fiocruz.br. Cristiane Oliveira da Mota, Gonçalo Moniz Public Health Central Laboratory (LACEN-BA), Salvador, Brazil, E-mail: parasitologia.lacenba@gmail.com. Fabricio Klerynton Marchini, Molecular Biology Institute of Paraná, Curitiba, Brazil, and Laboratory for Applied Science and Technology in Health, Carlos Chagas Institute, Oswaldo Cruz Foundation (FIOCRUZ-PR), Curitiba, Brazil, E-mail: fabricio.marchini@fiocruz.br. Paola Alejandra Fiorani Celedon, Carlos Chagas Institute (Fiocruz-PR), Laboratory of Molecular and Systems Biology of Trypanosomatids, Curitiba, Brazil, and Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil, E-mail: paola.fiorani@fiocruz.br. Nilson Ivo Tonin Zanchin, Carlos Chagas Institute (Fiocruz-PR), Structural Biology and Protein Engineering Laboratory, Curitiba, Brazil, Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil, and Integrated Translational Program in Chagas disease from FIOCRUZ (Fio-Chagas), Oswaldo Cruz Foundation (FIOCRUZ-RJ), Rio de Janeiro, Brazil, E-mail: nilson.zanchin@fiocruz.br. Fred Luciano Neves Santos, Gonçalo Moniz Institute (Fiocruz-BA), Advanced Public Health Laboratory, Salvador, Bahia, Brazil, and Oswaldo Cruz Foundation (Fiocruz-RJ), Interdisciplinary Research Group in Biotechnology and Epidemiology of Infectious Diseases (GRUPIBE), Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Brazil, and Integrated Translational Program in Chagas Disease from Fiocruz (Fio-Chagas), Rio de Janeiro, Rio de Janeiro, Brazil, E-mail: fred.santos@fiocruz.br.

Address correspondence to Fred Luciano Neves Santos, Gonçalo Moniz Institute, Oswaldo Cruz Foundation, Waldemar Falcão St., 121, Candeal, Salvador, Bahia 40296-710, Brazil. E-mail: fred.santos@fiocruz.br
Copyright:
© The author(s) 2024
Received:
07 Jun 2024
|
Accepted:
08 Jul 2024
|
Published Online:
29 Oct 2024
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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