Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG

J Clin Virol. 2020 Jul;128:104394. doi: 10.1016/j.jcv.2020.104394. Epub 2020 Apr 29.

Abstract

Background: Facing the ongoing pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), there is an urgent need for serological assays identifying individuals with past coronavirus disease 2019 (COVID-19).

Study design: Our study is the first to compare four new commercially available assays using 75 sera from patients tested positive or negative by SARS-CoV-2 PCR: the anti SARS-CoV-2 ELISA (IgG) (Euroimmun, Germany), the EDI New Coronavirus COVID-19 IgG ELISA, (Epitope diagnostics (EDI), USA), the recomWell SARS-CoV-2 IgG ELISA (Mikrogen, Germany), and the SARS-CoV-2 Virachip IgG (Viramed, Germany).

Results: We found a sensitivity of 86.4 %, 100 %, 86.4 %, and 77.3 % and a specificity of 96,2 %, 88,7 %, 100 %, and 100 % for the Euroimmun assay, the EDI assay, the Mikrogen assay, and the Viramed assay, respectively.

Conclusions: Commercially available SARS-CoV-2 IgG assays have a sufficient specificity and sensitivity for identifying individuals with past SARS-CoV-2 infection.

Keywords: COVID-19; ELISA; SARS-CoV-2.

Publication types

  • Comparative Study

MeSH terms

  • Antibodies, Viral / blood*
  • Betacoronavirus / immunology*
  • Clinical Laboratory Techniques / methods*
  • Coronavirus Infections / diagnosis*
  • Coronavirus Infections / virology
  • Enzyme-Linked Immunosorbent Assay / methods
  • Germany
  • Humans
  • Immunoglobulin G / blood*
  • Pandemics*
  • Pneumonia, Viral / diagnosis*
  • Pneumonia, Viral / virology
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Reagent Kits, Diagnostic

Supplementary concepts

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