Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/40983
Title: COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil
Authors: Castro, Rodolfo
Luz, Paula M.
Wakimoto, Mayumi D.
Veloso, Valdilea G.
Grinsztejn, Beatriz
Perazzo, Hugo
Affilliation: Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sergio Arouca. Rio de Janeiro, RJ, Brasil / Universidade Federal do Estado do Rio de Janeiro. Instituto de Saúde Coletiva. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil.
Abstract: The accuracy of commercially available tests for COVID-19 in Brazil remains unclear. We aimed to perform a meta-analysis to describe the accuracy of available tests to detect COVID19 in Brazil.We searched atthe Brazilian Health Regulatory Agency (ANVISA) online platform to describe the pooled sensitivity (Se), specificity (Sp), diagnostic odds ratio (DOR) and summary receiver operating characteristic curves (SROC) for detection of IgM/IgG antibodies and for tests using naso/oropharyngeal swabs in the random-effects models. We identified 16 tests registered, mostly rapid-tests. Pooled diagnostic accuracy measures [95%CI] were: (i) for IgM antibodies Se = 82% [76–87]; Sp = 97% [96–98]; DOR = 168 [92–305] and SROC= 0.98 [0.96–0.99]; (ii) for IgG antibodies Se = 97% [90–99]; Sp = 98% [97–99]; DOR = 1994 [385–10334] and SROC= 0.99 [0.98–1.00]; and (iii) for detection of SARS-CoV-2 by antigen or molecular assays in naso/oropharyngeal swabs Se = 97% [85–99]; Sp = 99% [77–100]; DOR = 2649 [30–233056] and SROC= 0.99 [0.98–1.00]. These tests can be helpful for emergency testing during the COVID-19 pandemic in Brazil. However, it is important to highlight the high rate of false negative results from tests which detect SARS-CoV-2 IgM antibodies in the initial course of the disease and the scarce evidence-based validation results published in Brazil. Future studies addressing the diagnostic performance of tests for COVID-19 in the Brazilian population are urgently needed.
Keywords: SARS-CoV-2
Coronavirus
COVID-19
Diagnostic accuracy
DeCS: Coronavirus Infections
Issue Date: 2020
Publisher: Elsevier
Citation: CASTRO, Rodolfo et al. COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil. The Brazilian Journal of Infectious Diseases, v. 968, p. 1-8, 2020.
Description: The authors declare no conflict of interest.
DOI: 10.1016/j.bjid.2020.04.003
ISSN: 1413-8670
Copyright: open access
Appears in Collections:ENSP - Artigos de Periódicos
INI - Artigos de Periódicos

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