Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.

<h4>Objective</h4>To evaluate diagnostic precision of two rapid diagnostic tests (RDT's) on patients with chronic Chagas disease.<h4>Methodology</h4>Prospective study with the following inclusion criteria: subjects older than 3 years, signed informed consent. Exclusion c...

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Autores principales:	Sandra Helena Suescún-Carrero, Lyda Pilar Salamanca-Cardozo, María-Jesus Pinazo, Lluis Armadans-Gil
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
Acceso en línea:	https://doaj.org/article/217fdc6149dc4770ba64f1a867a40c91
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spelling	oai:doaj.org-article:217fdc6149dc4770ba64f1a867a40c912021-11-25T06:33:09ZSensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.1935-27271935-273510.1371/journal.pntd.0009483https://doaj.org/article/217fdc6149dc4770ba64f1a867a40c912021-06-01T00:00:00Zhttps://doi.org/10.1371/journal.pntd.0009483https://doaj.org/toc/1935-2727https://doaj.org/toc/1935-2735<h4>Objective</h4>To evaluate diagnostic precision of two rapid diagnostic tests (RDT's) on patients with chronic Chagas disease.<h4>Methodology</h4>Prospective study with the following inclusion criteria: subjects older than 3 years, signed informed consent. Exclusion criterion: subjects could not have previously received treatment for infection with T. cruzi. The study population were participants in a screening process undertaken in rural and urban zones of the department Boyacá, Colombia. Two RDT's were performed to all participants: the Chagas Detect Plus InBios (CDP) and the Chagas Stat-Pak (CSP) and as a reference standard the ELISA Chagas III GrupoBios and the Chagas ELISA IgG+IgM I Vircell tests were used. In the case of discordant results between the two ELISA tests, an indirect immunofluorescence was done.<h4>Results</h4>Three hundred-five (305) subjects were included in the study (38 patients with leishmaniasis), of which 215 tested negative for T cruzi and 90 tested positive according to the reference standard. The sensitivity of the RDT's were 100% (CI 95% 95.9-100), and the specificity of the CDP was 99.1% (CI 95% 96.6-99.8) and for CSP was 100% (CI 95% 98.3-100). The agreement of CDP was 99.5% and for CSP was 100% with Kappa values of (k = 99.1; CI 95% 92.6-99.8%) and (k = 100; CI 95% 94.3-100), respectively. RDT's did not present cross-reactions with samples from patients who were positive for leishmaniasis.<h4>Conclusions</h4>The findings demonstrate excellent results from the RDT's in terms of validity, safety, and reproducibility. The results obtained provide evidence for the recommendation for using these tests in a Colombian epidemiological context principally in endemic areas in which laboratory installations necessary to perform conventional tests are not available, or they are scarce and to help in diagnosing chronic Chagas disease in order to provide access to treatment as soon as possible.Sandra Helena Suescún-CarreroLyda Pilar Salamanca-CardozoMaría-Jesus PinazoLluis Armadans-GilPublic Library of Science (PLoS)articleArctic medicine. Tropical medicineRC955-962Public aspects of medicineRA1-1270ENPLoS Neglected Tropical Diseases, Vol 15, Iss 6, p e0009483 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270
spellingShingle	Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Sandra Helena Suescún-Carrero Lyda Pilar Salamanca-Cardozo María-Jesus Pinazo Lluis Armadans-Gil Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.
description	<h4>Objective</h4>To evaluate diagnostic precision of two rapid diagnostic tests (RDT's) on patients with chronic Chagas disease.<h4>Methodology</h4>Prospective study with the following inclusion criteria: subjects older than 3 years, signed informed consent. Exclusion criterion: subjects could not have previously received treatment for infection with T. cruzi. The study population were participants in a screening process undertaken in rural and urban zones of the department Boyacá, Colombia. Two RDT's were performed to all participants: the Chagas Detect Plus InBios (CDP) and the Chagas Stat-Pak (CSP) and as a reference standard the ELISA Chagas III GrupoBios and the Chagas ELISA IgG+IgM I Vircell tests were used. In the case of discordant results between the two ELISA tests, an indirect immunofluorescence was done.<h4>Results</h4>Three hundred-five (305) subjects were included in the study (38 patients with leishmaniasis), of which 215 tested negative for T cruzi and 90 tested positive according to the reference standard. The sensitivity of the RDT's were 100% (CI 95% 95.9-100), and the specificity of the CDP was 99.1% (CI 95% 96.6-99.8) and for CSP was 100% (CI 95% 98.3-100). The agreement of CDP was 99.5% and for CSP was 100% with Kappa values of (k = 99.1; CI 95% 92.6-99.8%) and (k = 100; CI 95% 94.3-100), respectively. RDT's did not present cross-reactions with samples from patients who were positive for leishmaniasis.<h4>Conclusions</h4>The findings demonstrate excellent results from the RDT's in terms of validity, safety, and reproducibility. The results obtained provide evidence for the recommendation for using these tests in a Colombian epidemiological context principally in endemic areas in which laboratory installations necessary to perform conventional tests are not available, or they are scarce and to help in diagnosing chronic Chagas disease in order to provide access to treatment as soon as possible.
format	article
author	Sandra Helena Suescún-Carrero Lyda Pilar Salamanca-Cardozo María-Jesus Pinazo Lluis Armadans-Gil
author_facet	Sandra Helena Suescún-Carrero Lyda Pilar Salamanca-Cardozo María-Jesus Pinazo Lluis Armadans-Gil
author_sort	Sandra Helena Suescún-Carrero
title	Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.
title_short	Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.
title_full	Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.
title_fullStr	Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.
title_full_unstemmed	Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.
title_sort	sensitivity and specificity of two rapid tests for the diagnosis of infection by trypanosoma cruzi in a colombian population.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/217fdc6149dc4770ba64f1a867a40c91
work_keys_str_mv	AT sandrahelenasuescuncarrero sensitivityandspecificityoftworapidtestsforthediagnosisofinfectionbytrypanosomacruziinacolombianpopulation AT lydapilarsalamancacardozo sensitivityandspecificityoftworapidtestsforthediagnosisofinfectionbytrypanosomacruziinacolombianpopulation AT mariajesuspinazo sensitivityandspecificityoftworapidtestsforthediagnosisofinfectionbytrypanosomacruziinacolombianpopulation AT lluisarmadansgil sensitivityandspecificityoftworapidtestsforthediagnosisofinfectionbytrypanosomacruziinacolombianpopulation
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Sensitivity and Specificity of two rapid tests for the diagnosis of infection by Trypanosoma cruzi in a Colombian population.

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