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

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dc.creatorMariana Lourenço Freire
dc.creatorMaria Clara de Oliveira Gonçalves
dc.creatorAllana Carolina Marques da Silva
dc.creatorGlaucia Fernandes Cota
dc.creatorAna Rabello
dc.creatorTália Santana Machado de Assis
dc.date.accessioned2024-12-06T12:33:49Z
dc.date.accessioned2025-09-08T23:14:41Z
dc.date.available2024-12-06T12:33:49Z
dc.date.issued2023
dc.description.sponsorshipCNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
dc.format.mimetypepdf
dc.identifier.doihttps://doi.org/10.1590/0037-8682-0358-2022
dc.identifier.issn1678-9849
dc.identifier.urihttps://hdl.handle.net/1843/78494
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofRevista da Sociedade Brasileira de Medicina Tropical / Journal of the Brazilian Society of Tropical Medicine
dc.rightsAcesso Aberto
dc.subjectLeishmaniose Visceral
dc.subjectTestes de Diagnóstico Rápido
dc.subjectEstudo de Validação
dc.titleSerology for visceral leishmaniasis: how trusty is the accuracy reported by the manufacturers?
dc.typeArtigo de periódico
local.citation.epage10
local.citation.spage1
local.citation.volume56
local.description.resumoTimely 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.
local.publisher.countryBrasil
local.publisher.departmentMEDICINA - FACULDADE DE MEDICINA
local.publisher.initialsUFMG
local.url.externahttps://www.scielo.br/j/rsbmt/a/k4sbn8NnLJJmTzrLv4PwZQv/

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