| Autor | Silva, Severino Jefferson Ribeiro da | |
| Autor | Pena, Lindomar José | |
| Data de acesso | 2020-09-23T14:15:17Z | |
| Data de disponibilização | 2020-09-23T14:15:17Z | |
| Data do publicação | 2020 | |
| Citação | SILVA, Severino Jefferson Ribeiro da; PENA, Lindomar José. A word of caution in interpreting Covid-19 diagnostics tests. Journal of Medical Virology, p. 1-6, 19 Set. 2020. | |
| ISSN | 0146-6615 | |
| URI | https://www.arca.fiocruz.br/handle/icict/43566 | |
| Descrição | This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. | en_US |
| Descrição | Inclui carta do editor. | pt_BR |
| Idioma | eng | en_US |
| Editor | Wiley | |
| Direito Autoral | open access | |
| Palavras-chave | Bioestatística | pt_BR |
| Palavras-chave | Bioinformática | pt_BR |
| Palavras-chave | Epidemiologia | pt_BR |
| Palavras-chave | Pandemia | pt_BR |
| Palavras-chave | SARS coronavirus | pt_BR |
| Palavras-chave | Estatísticas de teste | pt_BR |
| Palavras-chave | COVID-19 | pt_BR |
| Palavras-chave | SARS-CoV-2 | pt_BR |
| Palavras-chave | Classificação de vírus | pt_BR |
| Título | A word of caution in interpreting Covid-19 diagnostics tests | en_US |
| Tipo do documento | Preprint | |
| DOI | 10.1002/jmv.26531 | |
| Resumo em Inglês | Since the emergence of SARS-CoV-2, many diagnostic tests including molecular and serological assays have been developed and approved by the Food and Drug Administration (FDA) for diagnosis of Covid-19. However, concerns about the sensitivity and specificity of many diagnostic assays, especially the rapid tests, have been raised. Diagnostic tests with unacceptable rates of false positive and false negative results interferes with therapeutic management of patients and can bring serious implications for public health authorities in the decision-making process regarding Covid-19 control. In this context, understanding key concepts in terms of development and validation of diagnostic assays is crucial for correct interpretation of test results. The parameters for validating diagnostic tests include analytical sensitivity, analytical specificity, clinical sensitivity, clinical specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value (PPV), negative predictive value (NPV), repeatability, reproducibility, and accuracy (Table 1). After initial development and optimization of a new Covid-19 test, the performance of the assay should be assessed using a set of well-defined clinical samples taking into account the required sample size. Ideally, data used for validation of Covid-19 test should be published in a peer-reviewed publication to allow independent evaluation. | en_US |
| Afiliação | Fundação Oswaldo Cruz. Instituto Aggeu Magalhães. Departamento de Virologia e Terapia Experimental. Recife, PE, Brasil. | |
| Afiliação | Fundação Oswaldo Cruz. Instituto Aggeu Magalhães. Departamento de Virologia e Terapia Experimental. Recife, PE, Brasil. | |
| Palavras-chave em inglês | Biostatistics | en_US |
| Palavras-chave em inglês | Bioinformatics | en_US |
| Palavras-chave em inglês | Epidemiology | en_US |
| Palavras-chave em inglês | Pandemics | en_US |
| Palavras-chave em inglês | SARS coronavirus | en_US |
| Palavras-chave em inglês | Test statistics | en_US |
| Palavras-chave em inglês | COVID-19 | en_US |
| Palavras-chave em inglês | SARS-CoV-2 | en_US |
| Palavras-chave em inglês | Virus classification | en_US |
| e-ISSN | 1096-9071 | |
| Documento revisado | Sim | |
| Status da publicação | Publicado | |
