Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil

Detalhes bibliográficos
Autor(a) principal: Medeiros, Fernanda Alvarenga Cardoso
Data de Publicação: 2021
Outros Autores: Souza Filho, Job Alves de, Barbosa, José Ronaldo, Donato, Lucas Edel, Figueiredo, Fabiano Borges, Werneck, Guilherme Loureiro, Paz, Gustavo Fontes, Thompson, Mayerson, Marcelino, Andreza Pain
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/51347
Resumo: Fundação Ezequiel Dias. Belo Horizonte, MG, Brasil.
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spelling Medeiros, Fernanda Alvarenga CardosoSouza Filho, Job Alves deBarbosa, José RonaldoDonato, Lucas EdelFigueiredo, Fabiano BorgesWerneck, Guilherme LoureiroPaz, Gustavo FontesThompson, MayersonMarcelino, Andreza Pain2022-02-21T18:56:05Z2022-02-21T18:56:05Z2021MEDEIROS, Fernanda Alvarenga Cardoso et al. Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil. Cad Saude Publica. v. 37, n. 3, :e00041320, 2021. doi: 10.1590/0102-311X00041320.0102-311Xhttps://www.arca.fiocruz.br/handle/icict/5134710.1590/0102-311X00041320.engEscola Nacional De Saúde Pública, Fundação Oswaldo CruzPhase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in BrazilEstudo de validação da fase II do teste ELISA rK39 para o diagnóstico da leishmaniose visceral canina no BrasilEstudio de validación de la fase II del test ELISA rK39 para el diagnóstico de la leishmaniasis visceral canina en Brasilinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Ezequiel Dias. Belo Horizonte, MG, Brasil.Fundação Ezequiel Dias. Belo Horizonte, MG, Brasil.Fundação Ezequiel Dias. Belo Horizonte, MG, Brasil.Ministério da Saúde. Brasília, DF, Brasil.Fundação Oswaldo Cruz. Instituto Carlos Chagas. Curitiba, SC, Brasil.Universidade do Estado do Rio de Janeiro. Instituto de Medicina Social. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Belo Horizonte, MG, Brasil.Universidade Federal de Minas Gerais. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.Dogs are the main reservoirs in the domestic transmission cycle of visceral leishmaniasis, and the diagnosis is essential for the effectiveness of the control measures recommended by the Brazilian Ministry of Health. We assessed the diagnostic performance of the ELISA-Vetlisa/BIOCLIN prototype with sérum samples from 200 dogs, in triplicate, including symptomatic, oligosymptomatic, asymptomatic, and healthy dogs, originated by two distinct panels (A and B) characterized by parasitological tests as the reference standard. In this study, the prototype kit showed a 99% sensitivity (95%CI: 94.5-100.0) and a 100% specificity (95%CI: 96.4-100.0). The sensitivity of the prototype kit did not vary significantly with the clinical status of the dogs. Considering the final result classification (positive or negative), agreement between the results of repeated tests was almost perfect (kappa = 0.99; 95%CI: 0.98-1.00). ELISA-Vetlisa/BIOCLIN is a promising option for the serological diagnosis of canine visceral leishmaniasis in Brazil.Enzyme-LinkedImmunosorbent AssayVisceral LeishmaniasisDogsDiagnosisinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83082https://www.arca.fiocruz.br/bitstream/icict/51347/1/license.txt9193a7c197bc67acd023525e72a03240MD51ORIGINALPhase II validation study of the rK39 ELISA.pdfPhase II validation study of the rK39 ELISA.pdfapplication/pdf8112524https://www.arca.fiocruz.br/bitstream/icict/51347/2/Phase%20II%20validation%20study%20of%20the%20rK39%20ELISA.pdf5a90d10b64f7cf36013b736f0878d24bMD52icict/513472022-02-21 15:56:05.599oai:www.arca.fiocruz.br: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Repositório 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dc.title.pt_BR.fl_str_mv Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
dc.title.alternative.pt_BR.fl_str_mv Estudo de validação da fase II do teste ELISA rK39 para o diagnóstico da leishmaniose visceral canina no Brasil
Estudio de validación de la fase II del test ELISA rK39 para el diagnóstico de la leishmaniasis visceral canina en Brasil
title Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
spellingShingle Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
Medeiros, Fernanda Alvarenga Cardoso
Enzyme-Linked
Immunosorbent Assay
Visceral Leishmaniasis
Dogs
Diagnosis
title_short Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
title_full Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
title_fullStr Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
title_full_unstemmed Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
title_sort Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
author Medeiros, Fernanda Alvarenga Cardoso
author_facet Medeiros, Fernanda Alvarenga Cardoso
Souza Filho, Job Alves de
Barbosa, José Ronaldo
Donato, Lucas Edel
Figueiredo, Fabiano Borges
Werneck, Guilherme Loureiro
Paz, Gustavo Fontes
Thompson, Mayerson
Marcelino, Andreza Pain
author_role author
author2 Souza Filho, Job Alves de
Barbosa, José Ronaldo
Donato, Lucas Edel
Figueiredo, Fabiano Borges
Werneck, Guilherme Loureiro
Paz, Gustavo Fontes
Thompson, Mayerson
Marcelino, Andreza Pain
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Medeiros, Fernanda Alvarenga Cardoso
Souza Filho, Job Alves de
Barbosa, José Ronaldo
Donato, Lucas Edel
Figueiredo, Fabiano Borges
Werneck, Guilherme Loureiro
Paz, Gustavo Fontes
Thompson, Mayerson
Marcelino, Andreza Pain
dc.subject.en.pt_BR.fl_str_mv Enzyme-Linked
Immunosorbent Assay
Visceral Leishmaniasis
Dogs
Diagnosis
topic Enzyme-Linked
Immunosorbent Assay
Visceral Leishmaniasis
Dogs
Diagnosis
description Fundação Ezequiel Dias. Belo Horizonte, MG, Brasil.
publishDate 2021
dc.date.issued.fl_str_mv 2021
dc.date.accessioned.fl_str_mv 2022-02-21T18:56:05Z
dc.date.available.fl_str_mv 2022-02-21T18:56:05Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv MEDEIROS, Fernanda Alvarenga Cardoso et al. Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil. Cad Saude Publica. v. 37, n. 3, :e00041320, 2021. doi: 10.1590/0102-311X00041320.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/51347
dc.identifier.issn.pt_BR.fl_str_mv 0102-311X
dc.identifier.doi.none.fl_str_mv 10.1590/0102-311X00041320.
identifier_str_mv MEDEIROS, Fernanda Alvarenga Cardoso et al. Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil. Cad Saude Publica. v. 37, n. 3, :e00041320, 2021. doi: 10.1590/0102-311X00041320.
0102-311X
10.1590/0102-311X00041320.
url https://www.arca.fiocruz.br/handle/icict/51347
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Escola Nacional De Saúde Pública, Fundação Oswaldo Cruz
publisher.none.fl_str_mv Escola Nacional De Saúde Pública, Fundação Oswaldo Cruz
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
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collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/51347/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/51347/2/Phase%20II%20validation%20study%20of%20the%20rK39%20ELISA.pdf
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