Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promises to assist in assessing exposure to and confirming the diagnosis of coronavirus disease 2019 (COVID-19), and to provide a roadmap for reopening countries worldwide. Considering this, a proper understanding of serologic-based diagnostic testing characteristics is critical. The aim of this study was to perform a structured systematic review and meta-analysis to evaluate the diagnostic characteristics of serological-based COVID-19 testing. Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. Full-text observational studies that reported IgG or IgM diagnostic yield and used nucleic acid amplification tests (NAATs) of respiratory tract specimens, as a the reference standard in English language were included. A bivariate model was used to compute pooled sensitivity, specificity, positive/negative likelihood ratio (LR), diagnostic odds ratio (OR), and summary receiver operating characteristic curve (SROC) with corresponding 95% confidence intervals (CIs). Five studies (n=1,166 individual tests) met inclusion criteria. The pooled sensitivity, specificity, and diagnostic accuracy for IgG was 81% [(95% CI, 61-92);I 2 =95.28], 97% [(95% CI, 78-100);I 2 =97.80], and 93% (95% CI, 91-95), respectively. The sensitivity, specificity, and accuracy for IgM antibodies was 80% [(95% CI, 57-92);I 2 =94.63], 96% [(95% CI, 81-99);I 2 =92.96] and 95% (95% CI, 92-96). This meta-analysis demonstrates suboptimal sensitivity and specificity of serologic-based diagnostic testing for SARS-CoV-2 and suggests that antibody testing alone, in its current form, is unlikely to be an adequate solution to the difficulties posed by COVID-19 and in guiding future policy decisions regarding social distancing and reopening of the economy worldwide.
【저자키워드】 COVID-19, coronavirus, Diagnosis, serological, SARS-CoV- 2, 【초록키워드】 coronavirus disease, Meta-analysis, SARS-CoV-2, IgG, IgM, Antibody testing, social distancing, diagnostic, systematic review, observational study, sensitivity, specificity, COVID-19 testing, Characteristics, Accuracy, Sensitivity and specificity, serologic, nucleic acid amplification, characteristic, Critical, reference standard, Odds ratio, English language, acute respiratory syndrome, 95% CI, 95% confidence interval, IgM antibody, inclusion criteria, Cochrane Library, likelihood ratio, respiratory tract specimens, country, performed, was used, evaluate, reported, unlikely, assist, CIs, 【제목키워드】 review,