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      COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil

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          Abstract

          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 COVID-19 in Brazil. We searched at the 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.

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          Author and article information

          Journal
          bjid
          Brazilian Journal of Infectious Diseases
          Braz J Infect Dis
          Brazilian Society of Infectious Diseases (Salvador, BA, Brazil )
          1413-8670
          1678-4391
          April 2020
          : 24
          : 2
          : 180-187
          Affiliations
          Rio de Janeiro orgnameFundação Oswaldo Cruz orgdiv1Instituto Nacional de Infectologia Evandro Chagas Brazil
          Rio de Janeiro orgnameFundação Oswaldo Cruz orgdiv1Escola Nacional de Saúde Pública Sergio Arouca Brazil
          Rio de Janeiro Rio de Janeiro orgnameUniversidade Federal do Estado do Rio de Janeiro orgdiv1Instituto de Saúde Coletiva Brazil
          Article
          S1413-86702020000200180 S1413-8670(20)02400200180
          10.1016/j.bjid.2020.04.003
          7165277

          This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

          Page count
          Figures: 0, Tables: 0, Equations: 0, References: 10, Pages: 8
          Product
          Product Information: website
          Categories
          Brief Communication

          Coronavirus, SARS-CoV-2, Diagnostic accuracy

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