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Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia

BACKGROUND: Chagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. The development of simplified diagnostic algorithms would enable progress in access to diagnos...

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Autores principales: Marchiol, Andrea, Florez Sanchez, Astrid Carolina, Caicedo, Andrés, Segura, Maryi, Bautista, Jessica, Ayala Sotelo, Martha Stella, Herazo, Rafael, Forsyth, Colin, Bohorquez, Laura C.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10473487/
https://www.ncbi.nlm.nih.gov/pubmed/37607214
http://dx.doi.org/10.1371/journal.pntd.0011547
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author Marchiol, Andrea
Florez Sanchez, Astrid Carolina
Caicedo, Andrés
Segura, Maryi
Bautista, Jessica
Ayala Sotelo, Martha Stella
Herazo, Rafael
Forsyth, Colin
Bohorquez, Laura C.
author_facet Marchiol, Andrea
Florez Sanchez, Astrid Carolina
Caicedo, Andrés
Segura, Maryi
Bautista, Jessica
Ayala Sotelo, Martha Stella
Herazo, Rafael
Forsyth, Colin
Bohorquez, Laura C.
author_sort Marchiol, Andrea
collection PubMed
description BACKGROUND: Chagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. The development of simplified diagnostic algorithms would enable progress in access to diagnosis; however, the current diagnostic algorithm relies on at least two laboratory-based tests that require qualified personnel, processing equipment, and infrastructure, which are still generally lacking at the primary care level. Rapid diagnostic tests (RDTs) for Chagas disease could simplify diagnosis, but their performance in the epidemiological context of Colombia is not well known. METHODOLOGY: A retrospective analytical observational study of RDTs was performed to estimate the operational characteristics of 11 commercially available RDTs designed for in vitro detection of anti-T. cruzi IgG antibodies. The study was performed under controlled laboratory conditions using human serum samples. PRINCIPAL FINDINGS: Eleven RDTs were assessed, ten using 585 serum samples and one using 551 serum samples. Employing the current national diagnostic algorithm as a reference standard for serological diagnosis of chronic infection, the sensitivity of the assessed RDTs ranged from 75.5% to 99.0% (95% CI 70.5–100), while specificity ranged from 70.9% to 100% (95% CI 65.3–100). Most tests (7/11, 63.6%) had sensitivity above 90%, and almost all (10/11, 90.9%) had specificity above 90%. Five RDTs had both sensitivity and specificity above 90%. CONCLUSIONS/SIGNIFICANCE: The evaluation of these 11 commercially available RDTs under controlled laboratory conditions is a first step in the assessment of the diagnostic performance of RDTs in Colombia. As a next step, field studies will be conducted on available RDTs with sensitivity and specificity greater than 90% in this study, to evaluate performance in real world conditions, with the final goal to allow simplified diagnostic algorithms.
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spelling pubmed-104734872023-09-02 Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia Marchiol, Andrea Florez Sanchez, Astrid Carolina Caicedo, Andrés Segura, Maryi Bautista, Jessica Ayala Sotelo, Martha Stella Herazo, Rafael Forsyth, Colin Bohorquez, Laura C. PLoS Negl Trop Dis Research Article BACKGROUND: Chagas disease is a public health challenge in Colombia, where only an estimated 1.2% of people at risk have accessed diagnosis, while less than 0.5% of affected people have obtained treatment. The development of simplified diagnostic algorithms would enable progress in access to diagnosis; however, the current diagnostic algorithm relies on at least two laboratory-based tests that require qualified personnel, processing equipment, and infrastructure, which are still generally lacking at the primary care level. Rapid diagnostic tests (RDTs) for Chagas disease could simplify diagnosis, but their performance in the epidemiological context of Colombia is not well known. METHODOLOGY: A retrospective analytical observational study of RDTs was performed to estimate the operational characteristics of 11 commercially available RDTs designed for in vitro detection of anti-T. cruzi IgG antibodies. The study was performed under controlled laboratory conditions using human serum samples. PRINCIPAL FINDINGS: Eleven RDTs were assessed, ten using 585 serum samples and one using 551 serum samples. Employing the current national diagnostic algorithm as a reference standard for serological diagnosis of chronic infection, the sensitivity of the assessed RDTs ranged from 75.5% to 99.0% (95% CI 70.5–100), while specificity ranged from 70.9% to 100% (95% CI 65.3–100). Most tests (7/11, 63.6%) had sensitivity above 90%, and almost all (10/11, 90.9%) had specificity above 90%. Five RDTs had both sensitivity and specificity above 90%. CONCLUSIONS/SIGNIFICANCE: The evaluation of these 11 commercially available RDTs under controlled laboratory conditions is a first step in the assessment of the diagnostic performance of RDTs in Colombia. As a next step, field studies will be conducted on available RDTs with sensitivity and specificity greater than 90% in this study, to evaluate performance in real world conditions, with the final goal to allow simplified diagnostic algorithms. Public Library of Science 2023-08-22 /pmc/articles/PMC10473487/ /pubmed/37607214 http://dx.doi.org/10.1371/journal.pntd.0011547 Text en © 2023 Marchiol et al https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Marchiol, Andrea
Florez Sanchez, Astrid Carolina
Caicedo, Andrés
Segura, Maryi
Bautista, Jessica
Ayala Sotelo, Martha Stella
Herazo, Rafael
Forsyth, Colin
Bohorquez, Laura C.
Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia
title Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia
title_full Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia
title_fullStr Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia
title_full_unstemmed Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia
title_short Laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of Chagas disease in Colombia
title_sort laboratory evaluation of eleven rapid diagnostic tests for serological diagnosis of chagas disease in colombia
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10473487/
https://www.ncbi.nlm.nih.gov/pubmed/37607214
http://dx.doi.org/10.1371/journal.pntd.0011547
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