Meta-analysis of diagnostic performance of serology tests for COVID-19: impact of assay design and post-symptom-onset intervals

Emerg Microbes Infect. 2020 Dec;9(1):2200-2211. doi: 10.1080/22221751.2020.1826362.

Abstract

Serology detection is recognized for its sensitivity in convalescent patients with COVID-19, in comparison with nucleic acid amplification tests (NAATs). This article aimed to evaluate the diagnostic accuracy of serologic methods for COVID-19 based on assay design and post-symptom-onset intervals. Two authors independently searched PubMed, Cochrane library, Ovid, EBSCO for case-control, longitudinal and cohort studies that determined the diagnostic accuracy of serology tests in comparison with NAATs in COVID-19 cases and used QUADAS-2 for quality assessment. Pooled accuracy was analysed using INLA method. A total of 27 studies were included in this meta-analysis, with 4 cohort, 16 case-control and 7 longitudinal studies and 4565 participants. Serology tests had the lowest sensitivity at 0-7 days after symptom onset and the highest at >14 days. TAB had a better sensitivity than IgG or IgM only. Using combined nucleocapsid (N) and spike(S) protein had a better sensitivity compared to N or S protein only. Lateral flow immunoassay (LFIA) had a lower sensitivity than enzyme-linked immunoassay (ELISA) and chemiluminescent immunoassay (CLIA). Serology tests will play an important role in the clinical diagnosis for later stage COVID-19 patients. ELISA tests, detecting TAB or targeting combined N and S proteins had a higher diagnostic sensitivity compared to other methods.

Keywords: COVID-19; SARS-CoV-2; immunoassays; metanalysis; serology.

Publication types

  • Meta-Analysis

MeSH terms

  • Antibodies, Viral / blood
  • Antibodies, Viral / immunology
  • Antigens, Viral / immunology
  • Betacoronavirus* / immunology
  • COVID-19
  • COVID-19 Testing
  • Clinical Laboratory Techniques / methods*
  • Clinical Laboratory Techniques / standards
  • Coronavirus Infections / diagnosis*
  • Coronavirus Infections / immunology
  • Coronavirus Infections / virology*
  • Humans
  • Immunoassay / methods
  • Immunoassay / standards
  • Immunoglobulin G / blood
  • Immunoglobulin G / immunology
  • Immunoglobulin M / blood
  • Immunoglobulin M / immunology
  • Pandemics
  • Pneumonia, Viral / diagnosis*
  • Pneumonia, Viral / immunology
  • Pneumonia, Viral / virology*
  • Publication Bias
  • SARS-CoV-2
  • Sensitivity and Specificity
  • Serologic Tests / methods*
  • Serologic Tests / standards
  • Symptom Assessment

Substances

  • Antibodies, Viral
  • Antigens, Viral
  • Immunoglobulin G
  • Immunoglobulin M