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

Detalhes bibliográficos
Autor(a) principal: Fernanda Alvarenga Cardoso Medeiros
Data de Publicação: 2021
Outros Autores: Job Alves de Souza Filho, José Ronaldo Barbosa, Lucas Edel Donato, Fabiano Borges Figueiredo, Guilherme Loureiro Werneck, Gustavo Fontes Paz, Mayerson Thompson, Andreza Pain Marcelino
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Cadernos de Saúde Pública
Texto Completo: https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804
Resumo: 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 serum 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.
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spelling Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in BrazilEnzyme-Linked Immunosorbent AssayVisceral LeishmaniasisDogsDiagnosisDogs 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 serum 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.Los perros son los principales reservorios en el ciclo de transmisión doméstica de la leishmaniasis visceral, por ello el diagnóstico es esencial para la efectividad de las medidas de control recomendadas por el Ministerio de Salud de Brasil. Evaluamos el desempeño diagnóstico de ELISA-Vetlisa/BIOCLIN prototipo con muestras de sérum de 200 perros, en triplicado, incluyendo sintomático, oligosintomático, asintomático y perros sanos, originadas por dos paneles distintos (A y B), caracterizados por test parasitológicos como referencia estándar. En este estudio, el kit prototipo mostró un 99% de sensibilidad (IC95%: 94,5-100,0) y un 100% de especificidad (IC95%: 96,4-100,0). La sensibilidad del kit prototipo no varió significativamente con el estatus clínico de los perros. Considerando la clasificación final del resultado (positiva o negativa), el acuerdo entre los resultados de los tests repetidos fue casi perfecto (kappa = 0,99; IC95%: 0,98-1,00). ELISA-Vetlisa/BIOCLIN tiene potencial para ser usado para el diagnóstico serológico de la leishmaniasis visceral canina en Brasil.Os cães são os principais reservatórios do ciclo de transmissão domiciliar da leishmaniose visceral, e o diagnóstico é essencial para a efetividade das medidas de controle recomendadas pelo Ministério da Saúde. Os autores avaliam o desempenho diagnóstico do protótipo da ELISA-Vetlisa/BIOCLIN em amostras sorológicas de 200 cães, em triplicata, incluindo cães sintomáticos, oligossintomáticos e saudáveis, com dois painéis distintos (A e B) caracterizados por testes parasitológicos enquanto referência. No estudo, o kit-protótipo mostrou sensibilidade de 99% (IC95%: 94,5-100,0) e especificidade de 100% (IC95%: 96,4-100,0). A sensibilidade do kit-protótipo não variou de maneira significativa de acordo com o estado clínico dos cães. Considerando a classificação final dos resultados (positivo ou negativo), a concordância entre os resultados dos testes em triplicata foi quase perfeita (kappa = 0,99; IC95%: 0,98-1,00). O protótipo ELISA-Vetlisa/BIOCLIN tem o potencial de ser utilizada para o diagnóstico sorológico da leishmaniose visceral canina no Brasil.Reports in Public HealthCadernos de Saúde Pública2021-04-07info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlapplication/pdfhttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804Reports in Public Health; Vol. 37 No. 3 (2021): MarchCadernos de Saúde Pública; v. 37 n. 3 (2021): Março1678-44640102-311Xreponame:Cadernos de Saúde Públicainstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZenghttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804/17452https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804/17453Fernanda Alvarenga Cardoso MedeirosJob Alves de Souza FilhoJosé Ronaldo BarbosaLucas Edel DonatoFabiano Borges FigueiredoGuilherme Loureiro WerneckGustavo Fontes PazMayerson ThompsonAndreza Pain Marcelinoinfo:eu-repo/semantics/openAccess2024-03-06T15:30:12Zoai:ojs.teste-cadernos.ensp.fiocruz.br:article/7804Revistahttps://cadernos.ensp.fiocruz.br/ojs/index.php/csphttps://cadernos.ensp.fiocruz.br/ojs/index.php/csp/oaicadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br1678-44640102-311Xopendoar:2024-03-06T13:08:58.202300Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)true
dc.title.none.fl_str_mv Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil
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
Fernanda Alvarenga Cardoso Medeiros
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 Fernanda Alvarenga Cardoso Medeiros
author_facet Fernanda Alvarenga Cardoso Medeiros
Job Alves de Souza Filho
José Ronaldo Barbosa
Lucas Edel Donato
Fabiano Borges Figueiredo
Guilherme Loureiro Werneck
Gustavo Fontes Paz
Mayerson Thompson
Andreza Pain Marcelino
author_role author
author2 Job Alves de Souza Filho
José Ronaldo Barbosa
Lucas Edel Donato
Fabiano Borges Figueiredo
Guilherme Loureiro Werneck
Gustavo Fontes Paz
Mayerson Thompson
Andreza Pain Marcelino
author2_role author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Fernanda Alvarenga Cardoso Medeiros
Job Alves de Souza Filho
José Ronaldo Barbosa
Lucas Edel Donato
Fabiano Borges Figueiredo
Guilherme Loureiro Werneck
Gustavo Fontes Paz
Mayerson Thompson
Andreza Pain Marcelino
dc.subject.por.fl_str_mv Enzyme-Linked Immunosorbent Assay
Visceral Leishmaniasis
Dogs
Diagnosis
topic Enzyme-Linked Immunosorbent Assay
Visceral Leishmaniasis
Dogs
Diagnosis
description 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 serum 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.
publishDate 2021
dc.date.none.fl_str_mv 2021-04-07
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804
url https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804/17452
https://cadernos.ensp.fiocruz.br/ojs/index.php/csp/article/view/7804/17453
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
application/pdf
dc.publisher.none.fl_str_mv Reports in Public Health
Cadernos de Saúde Pública
publisher.none.fl_str_mv Reports in Public Health
Cadernos de Saúde Pública
dc.source.none.fl_str_mv Reports in Public Health; Vol. 37 No. 3 (2021): March
Cadernos de Saúde Pública; v. 37 n. 3 (2021): Março
1678-4464
0102-311X
reponame:Cadernos de Saúde Pública
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos de Saúde Pública
collection Cadernos de Saúde Pública
repository.name.fl_str_mv Cadernos de Saúde Pública - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos@ensp.fiocruz.br||cadernos@ensp.fiocruz.br
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