Diagnostic Characteristics of Serological-Based COVID-19 Testing: A Systematic Review and Meta-Analysis

Clinics (Sao Paulo). 2020;75:e2212. doi: 10.6061/clinics/2020/e2212. Epub 2020 Aug 10.

Abstract

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.

Publication types

  • Meta-Analysis
  • Systematic Review

MeSH terms

  • Antibodies, Viral / blood*
  • Betacoronavirus
  • Clinical Laboratory Techniques
  • Coronavirus Infections / diagnosis*
  • Humans
  • Immunoglobulin G / blood
  • Immunoglobulin M / blood
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Sensitivity and Specificity
  • Serologic Tests*

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin M

Supplementary concepts

  • COVID-19
  • COVID-19 diagnostic testing
  • severe acute respiratory syndrome coronavirus 2