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

Frontiers in Medicine

Medicine

Leonardo Maia Leony¹  Fred Luciano Neves Santos²  Suelene Brito Tavares³  Alejandro Ostermayer Luquetti³  Liliane da Rocha Siriano³  Vinícius Silva Belo⁴  Andréa Silvestre de Sousa⁵  Fernanda Alvarenga Cardoso Medeiros⁶  Jacqueline Araújo Domingos Iturra⁶  Job Alves de Souza Filho⁶ 

[1] Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Bahia, Brazil;Advanced Public Health Laboratory, Gonçalo Moniz Institute, Oswaldo Cruz Foundation (FIOCRUZ-BA), Salvador, Bahia, Brazil;Integrated Translational Program in Chagas Disease from FIOCRUZ (Fio-Chagas), Oswaldo Cruz Foundation (FIOCRUZ-RJ), Rio de Janeiro, Brazil;Chagas Disease Study Center (NEDoC), University Hospital, Federal University of Goiás (UFG), Goiânia, Goiás, Brazil;Department of Health Sciences, Federal University of São João Del-Rei (UFSJ), Divinópolis, Minas Gerais, Brazil;Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation (FIOCRUZ-RJ), Rio de Janeiro, Brazil;Integrated Translational Program in Chagas Disease from FIOCRUZ (Fio-Chagas), Oswaldo Cruz Foundation (FIOCRUZ-RJ), Rio de Janeiro, Brazil;Parasitic Diseases Service, Ezequiel Dias Foundation (FUNED), Belo Horizonte, Minas Gerais, Brazil;

关键词: Chagas disease;    serology;    rapid diagnostic tests;    performance;    screening;   

DOI  :  10.3389/fmed.2023.1031455

 received in 2022-08-30, accepted in 2023-02-10,  发布年份 2023

来源: Frontiers

【 摘 要 】

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.

【 授权许可】

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Copyright © 2023 Iturra, Leony, Medeiros, Souza Filho, Siriano, Tavares, Luquetti, Belo, Sousa and Santos.