Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis

Area of Science:

• Immunology and Infectious Diseases
• Diagnostic Test Evaluation
• Epidemiology

Background:

• The COVID-19 pandemic necessitated reliable diagnostic tools beyond Nucleic Acid Tests (NAT).
• Serological antibody tests offer a complementary approach for identifying SARS-CoV-2 infection.
• Variability in individual study results highlights the need for comparative analysis of antibody tests.

Purpose of the Study:

• To systematically review and meta-analyze the diagnostic performance of various COVID-19 antibody tests.
• To compare the sensitivity and specificity of different immunoassay platforms and antigen targets.
• To guide the selection of appropriate serological tests for clinical and epidemiological purposes.

Main Methods:

• Systematic review and bivariate meta-analysis of studies from PubMed, medRxiv, and bioRxiv.
• Evaluation of Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA), and Lateral Flow Immunoassays (LFIA).
• Analysis of IgM, IgG, and combined IgG/IgM antibody tests, considering S and N antigen targets.

Main Results:

• Thirty-eight studies including 7848 individuals were analyzed.
• S antigen-based tests demonstrated higher sensitivity than N antigen-based tests.
• IgG tests outperformed IgM tests, with improved sensitivity observed later post-symptom onset.
• Combined IgG/IgM tests showed superior sensitivity compared to single antibody tests.
• High specificity (>99%) was achieved by ELISA and LFIA.
• ELISA and CLIA exhibited the highest sensitivity (90%-94%), followed by LFIA and FIA (80%-89%).

Conclusions:

• ELISA tests are recommended as a reliable option during the current pandemic phase.
• LFIA tests are suitable for large-scale seroprevalence studies, but their lower sensitivity must be considered.
• The choice of antibody test should be informed by its performance characteristics and intended application.