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);I2=95.28], 97% [(95% CI, 78-100);I2=97.80], and 93% (95% CI, 91-95), respectively. The
sensitivity,
specificity, and accuracy for
IgM antibodies was 80% [(95% CI, 57-92);I2=94.63], 96% [(95% CI, 81-99);I2=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.