Diagnostic efficacy of anti-SARS-CoV-2 IgG/IgM test for Covid-19: A meta-analysis.

The serological testing of anti-SARS-CoV-2 IgG and/or IgM is widely used in the diagnosis of COVID-19. However, its diagnostic efficacy remains unclear. In this study, we searched diagnostic studies from Web of Science, PubMed, Embase, CNKI, Wanfang databases to calculate the pooled diagnostic accuracy measures using bivariate random-effects model meta-analysis. As a result, 22 from a total of 1613 articles, including 2,282 patients with SARS-CoV-2 and 1,485 healthy persons or patients without SARS-CoV-2, were selected for a meta-analysis. Pooled sensitivity, specificity, and area under curve (AUC) of summary receiver operator curve (SROC) were: (i) 0.85 (95% CI.: 0.79- 0.90), 0.99 (95% CI.: 0.98- 1.00), and 0.99 (95% CI.: 0.97- 0.99) for anti-SARS-CoV-2 IgG; (ii) 0.74 (95% CI.: 0.65- 0.81), 0.99 (95% CI.: 0.97- 1.00), and 0.95 (95% CI.: 0.93- 0.97) for IgM. A subgroup analysis among detection methods indicated the sensitivity of IgG and IgM using ELISA were slightly lower than those using gold immunochromatography assay (GICA) and chemiluminescence immunoassay (CLIA) (p > .05) These results showed that the detection of anti-SARS-CoV-2 IgG and IgM had high diagnostic efficiency to assist the diagnosis of SARS-CoV-2 infection. And, GICA might be used as the preferred method for its accuracy and simplicity. This article is protected by copyright. All rights reserved.