Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?

Detalhes bibliográficos
Autor(a) principal: Freire, Mariana Lourenço
Data de Publicação: 2023
Outros Autores: Gonçalves, Maria Clara de Oliveira, Silva, Allana Carolina Marques da, Cota, Gláucia Fernandes, Rabello, Ana Lucia Teles, Assis, Tália Santana Machado de
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/57376
Resumo: Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil.
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spelling Freire, Mariana LourençoGonçalves, Maria Clara de OliveiraSilva, Allana Carolina Marques daCota, Gláucia FernandesRabello, Ana Lucia TelesAssis, Tália Santana Machado de2023-03-14T19:18:15Z2023-03-14T19:18:15Z2023FREIRE, Mariana Lourenço et al. Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers? Revista da Sociedade Brasileira de Medicina Tropical, v. 56, p. 1-10, 2023.0037-8682https://www.arca.fiocruz.br/handle/icict/5737610.1590/0037-8682-0358-2022engSociedade Brasileira de Medicina TropicalVisceral leishmaniasisDiagnostic testsPerformanceAccuracyValidationSerology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil.Centro Federal de Educação Tecnológica de Minas Gerais. Contagem, MG, Brasil.Centro Federal de Educação Tecnológica de Minas Gerais. Contagem, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil.Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil / Centro Federal de Educação Tecnológica de Minas Gerais. Contagem, MG, Brasil.Timely and accurate diagnosis is one of the strategies for managing visceral leishmaniasis (VL). Given the specificities of this infection, which affects different vulnerable populations, the local assessment of the accuracy of the available diagnostic test is a requirement for the good use of resources. In Brazil, performance data are required for test registration with the National Regulatory Agency (ANVISA), but there are no minimum requirements established for performance evaluation. Here, we compared the accuracy reported in the manufacturer’s instructions of commercially available VL-diagnostic tests in Brazil, and the accuracies reported in the scientific literature which were obtained after test commercialization. The tests were identified via the electronic database of ANVISA, and their accuracy was obtained from the manufacturer’s instructions. A literature search for test accuracy was performed using two databases. A total of 28 VL diagnostic tests were identified through the ANVISA database. However, only 13 presented performance data in the manufacturer’s instructions, with five immunoenzymatic tests, three indirect immunofluorescence tests, one chemiluminescence test, and four rapid tests. For most tests, the manufacturers did not provide the relevant information, such as sample size, reference standards, and study site. The literature review identified accuracy data for only 61.5% of diagnostic tests registered in Brazil. These observations confirmed that there are significant flaws in the process of registering health technologies and highlighted one of the reasons for the insufficient control of policies, namely, the use of potentially inaccurate and inappropriate diagnostic tools for a given scenario.info:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/57376/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALSerology for visceral leishmaniasis.pdfSerology for visceral leishmaniasis.pdfapplication/pdf424555https://www.arca.fiocruz.br/bitstream/icict/57376/2/Serology%20for%20visceral%20leishmaniasis.pdf45f35d67d88771c23c8f386bc4c38485MD52icict/573762023-11-08 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dc.title.en_US.fl_str_mv Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
title Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
spellingShingle Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
Freire, Mariana Lourenço
Visceral leishmaniasis
Diagnostic tests
Performance
Accuracy
Validation
title_short Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
title_full Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
title_fullStr Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
title_full_unstemmed Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
title_sort Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers?
author Freire, Mariana Lourenço
author_facet Freire, Mariana Lourenço
Gonçalves, Maria Clara de Oliveira
Silva, Allana Carolina Marques da
Cota, Gláucia Fernandes
Rabello, Ana Lucia Teles
Assis, Tália Santana Machado de
author_role author
author2 Gonçalves, Maria Clara de Oliveira
Silva, Allana Carolina Marques da
Cota, Gláucia Fernandes
Rabello, Ana Lucia Teles
Assis, Tália Santana Machado de
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Freire, Mariana Lourenço
Gonçalves, Maria Clara de Oliveira
Silva, Allana Carolina Marques da
Cota, Gláucia Fernandes
Rabello, Ana Lucia Teles
Assis, Tália Santana Machado de
dc.subject.other.en_US.fl_str_mv Visceral leishmaniasis
Diagnostic tests
topic Visceral leishmaniasis
Diagnostic tests
Performance
Accuracy
Validation
dc.subject.en.en_US.fl_str_mv Performance
Accuracy
Validation
description Fundação Oswaldo Cruz. Instituto René Rachou. Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias. Belo Horizonte, MG, Brasil.
publishDate 2023
dc.date.accessioned.fl_str_mv 2023-03-14T19:18:15Z
dc.date.available.fl_str_mv 2023-03-14T19:18:15Z
dc.date.issued.fl_str_mv 2023
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 FREIRE, Mariana Lourenço et al. Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers? Revista da Sociedade Brasileira de Medicina Tropical, v. 56, p. 1-10, 2023.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/57376
dc.identifier.issn.en_US.fl_str_mv 0037-8682
dc.identifier.doi.none.fl_str_mv 10.1590/0037-8682-0358-2022
identifier_str_mv FREIRE, Mariana Lourenço et al. Serology for visceral leishmaniasis: How trusty is the accuracy reported by the manufacturers? Revista da Sociedade Brasileira de Medicina Tropical, v. 56, p. 1-10, 2023.
0037-8682
10.1590/0037-8682-0358-2022
url https://www.arca.fiocruz.br/handle/icict/57376
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 Sociedade Brasileira de Medicina Tropical
publisher.none.fl_str_mv Sociedade Brasileira de Medicina Tropical
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/57376/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/57376/2/Serology%20for%20visceral%20leishmaniasis.pdf
bitstream.checksum.fl_str_mv 5a560609d32a3863062d77ff32785d58
45f35d67d88771c23c8f386bc4c38485
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
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