Evaluation of four laboratory-based SARS-CoV-2 IgG antibody immunoassays

Diagn Microbiol Infect Dis. 2021 May;100(1):115313. doi: 10.1016/j.diagmicrobio.2021.115313. Epub 2021 Jan 19.

Abstract

Objectives: To evaluate the diagnostic performances of four SARS-CoV-2 IgG antibody immunoassays.

Methods: Following immunoassays were studied: Abbott's SARS-CoV-2 IgG assay, Diasorin's Liaison SARS-CoV-2 S2/S2 IgG assay, Euroimmun's Anti-SARS-CoV-2 IgG ELISA, and Roche's Elecsys Anti-SARS-CoV-2 assay. Specificity was retrospectively evaluated with 38 samples from 2019. Sensitivity samples (n = 147) were taken from SARS-CoV-2 real-time PCR-positive patients who developed COVID-19 symptoms ten days earlier.

Results: Mean specificity was 96.6%. Mean sensitivity was 62.7% from ten days after onset of symptoms, 84.4% from 15 days after onset of symptoms, and 87.5% from 20 days after onset of symptoms.

Conclusions: Specificity was high, while Abbott and Roche were 100% specific. Sensitivity increased over time, with Abbott and Roche having the highest sensitivity at all time points with ≥90% from 20 days after symptoms' onset. These findings may assist in selecting SARS-CoV-2 IgG antibody immunoassays for additional diagnostics, epidemiological research, and vaccine development.

Keywords: COVID-19; IgG; Immunoassay; SARS-CoV-2; Sensitivity; Specificity.

Publication types

  • Evaluation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Antibodies, Viral / blood*
  • COVID-19 Serological Testing / methods*
  • Child
  • Child, Preschool
  • Epstein-Barr Virus Infections / blood
  • Epstein-Barr Virus Infections / virology
  • Female
  • Humans
  • Immunoassay / methods*
  • Immunoglobulin G / blood
  • Infant
  • Male
  • Middle Aged
  • Retrospective Studies
  • SARS-CoV-2 / immunology
  • Sensitivity and Specificity
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G