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A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil

Diagnosis of Trypanosoma cruzi (T. cruzi) infection in the chronic phase of Chagas disease (CD) is performed by serologic testing. Conventional tests are currently used with very good results but require time, laboratory infrastructure, and expertise. Rapid diagnostic tests (RDTs) are an alternative...

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Autores principales: Iturra, Jacqueline Araújo Domingos, Leony, Leonardo Maia, Medeiros, Fernanda Alvarenga Cardoso, de Souza Filho, Job Alves, Siriano, Liliane da Rocha, Tavares, Suelene Brito, Luquetti, Alejandro Ostermayer, Belo, Vinícius Silva, de Sousa, Andréa Silvestre, Santos, Fred Luciano Neves
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10017777/
https://www.ncbi.nlm.nih.gov/pubmed/36936214
http://dx.doi.org/10.3389/fmed.2023.1031455
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author Iturra, Jacqueline Araújo Domingos
Leony, Leonardo Maia
Medeiros, Fernanda Alvarenga Cardoso
de Souza Filho, Job Alves
Siriano, Liliane da Rocha
Tavares, Suelene Brito
Luquetti, Alejandro Ostermayer
Belo, Vinícius Silva
de Sousa, Andréa Silvestre
Santos, Fred Luciano Neves
author_facet Iturra, Jacqueline Araújo Domingos
Leony, Leonardo Maia
Medeiros, Fernanda Alvarenga Cardoso
de Souza Filho, Job Alves
Siriano, Liliane da Rocha
Tavares, Suelene Brito
Luquetti, Alejandro Ostermayer
Belo, Vinícius Silva
de Sousa, Andréa Silvestre
Santos, Fred Luciano Neves
author_sort Iturra, Jacqueline Araújo Domingos
collection PubMed
description Diagnosis of Trypanosoma cruzi (T. cruzi) infection in the chronic phase of Chagas disease (CD) is performed by serologic testing. Conventional tests are currently used with very good results but require time, laboratory infrastructure, and expertise. Rapid diagnostic tests (RDTs) are an alternative as the results are immediate and do not require specialized knowledge, making them suitable for epidemiologic studies and promising as a screening tool. Nevertheless, few studies conducted comparative evaluations of RDTs to validate the results and assess their performance. In this study, we analyzed four trades of rapid tests (OnSite Chagas Ab Combo Rapid Test-United States, SD Bioline Chagas AB-United States, WL Check Chagas-Argentina, and TR Chagas Bio-Manguinhos-Brazil) using a panel of 190 samples, including sera from 111 infected individuals, most of whom had low T. cruzi antibody levels. An additional 59 samples from uninfected individuals and 20 sera from individuals with other diseases, mainly visceral leishmaniasis, were included. All tests were performed by three independent laboratories in a blinded manner. Results showed differences in sensitivity from 92.8 to 100%, specificity from 78.5 to 92.4%, and accuracy from 90.5 to 95.3% among the four assays. The results presented here show that all four RDTs have high overall diagnostic ability. However, WL Check Chagas and TR Chagas Bio-Manguinhos were considered most suitable for use in screening studies due to their high sensitivity combined with good performance. Although these two RDTs have high sensitivity, a positive result should be confirmed with other tests to confirm or rule out reactivity/positivity, especially considering possible cross-reactivity with individuals with leishmaniasis or toxoplasmosis.
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spelling pubmed-100177772023-03-17 A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil Iturra, Jacqueline Araújo Domingos Leony, Leonardo Maia Medeiros, Fernanda Alvarenga Cardoso de Souza Filho, Job Alves Siriano, Liliane da Rocha Tavares, Suelene Brito Luquetti, Alejandro Ostermayer Belo, Vinícius Silva de Sousa, Andréa Silvestre Santos, Fred Luciano Neves Front Med (Lausanne) Medicine Diagnosis of Trypanosoma cruzi (T. cruzi) infection in the chronic phase of Chagas disease (CD) is performed by serologic testing. Conventional tests are currently used with very good results but require time, laboratory infrastructure, and expertise. Rapid diagnostic tests (RDTs) are an alternative as the results are immediate and do not require specialized knowledge, making them suitable for epidemiologic studies and promising as a screening tool. Nevertheless, few studies conducted comparative evaluations of RDTs to validate the results and assess their performance. In this study, we analyzed four trades of rapid tests (OnSite Chagas Ab Combo Rapid Test-United States, SD Bioline Chagas AB-United States, WL Check Chagas-Argentina, and TR Chagas Bio-Manguinhos-Brazil) using a panel of 190 samples, including sera from 111 infected individuals, most of whom had low T. cruzi antibody levels. An additional 59 samples from uninfected individuals and 20 sera from individuals with other diseases, mainly visceral leishmaniasis, were included. All tests were performed by three independent laboratories in a blinded manner. Results showed differences in sensitivity from 92.8 to 100%, specificity from 78.5 to 92.4%, and accuracy from 90.5 to 95.3% among the four assays. The results presented here show that all four RDTs have high overall diagnostic ability. However, WL Check Chagas and TR Chagas Bio-Manguinhos were considered most suitable for use in screening studies due to their high sensitivity combined with good performance. Although these two RDTs have high sensitivity, a positive result should be confirmed with other tests to confirm or rule out reactivity/positivity, especially considering possible cross-reactivity with individuals with leishmaniasis or toxoplasmosis. Frontiers Media S.A. 2023-03-02 /pmc/articles/PMC10017777/ /pubmed/36936214 http://dx.doi.org/10.3389/fmed.2023.1031455 Text en Copyright © 2023 Iturra, Leony, Medeiros, Souza Filho, Siriano, Tavares, Luquetti, Belo, Sousa and Santos. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Iturra, Jacqueline Araújo Domingos
Leony, Leonardo Maia
Medeiros, Fernanda Alvarenga Cardoso
de Souza Filho, Job Alves
Siriano, Liliane da Rocha
Tavares, Suelene Brito
Luquetti, Alejandro Ostermayer
Belo, Vinícius Silva
de Sousa, Andréa Silvestre
Santos, Fred Luciano Neves
A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil
title A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil
title_full A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil
title_fullStr A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil
title_full_unstemmed A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil
title_short A multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-Trypanosoma cruzi antibodies in Brazil
title_sort multicenter comparative study of the performance of four rapid immunochromatographic tests for the detection of anti-trypanosoma cruzi antibodies in brazil
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10017777/
https://www.ncbi.nlm.nih.gov/pubmed/36936214
http://dx.doi.org/10.3389/fmed.2023.1031455
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