Comprehensive evaluation of eight commercial SARS-CoV-2 IgG assays

Diagn Microbiol Infect Dis. 2021 Aug;100(4):115382. doi: 10.1016/j.diagmicrobio.2021.115382. Epub 2021 Mar 22.

Abstract

Sensitivity and specificity of serological assays are key parameters for the accurate estimation of SARS-CoV-2 sero-prevalence. The aim of this study was to compare 8 readily available IgG antibody tests using a panel of well-defined serum samples of prepandemic and pandemic origin. A cross-reaction panel included samples of patients with recent infection with either of the endemic Coronaviruses 229E, NL63, HKU1, or OC43. Additionally, samples with high antibody levels against influenza virus, adenovirus, and during acute EBV infection were included. Previous infection with endemic coronaviruses caused a significant amount of cross-reactivity in two of the assays. In contrast, the confidence intervals for the assays of Abbott, DiaSorin, Euroimmun and Roche encompassed the value of 98% for samples with a previous endemic HCoV infection. For all assays, sensitivities were between 91.3% and 98.8%. Assay performance was independent of the usage of either nucleocapsid or spike proteins.

Keywords: Covid-19; Cross-reactivity; SARS-CoV-2; Sensitivity; serology.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Viral / blood*
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 Serological Testing / methods*
  • COVID-19 Serological Testing / standards
  • Child
  • Female
  • Humans
  • Immunoglobulin G / blood*
  • Male
  • Middle Aged
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • Seroepidemiologic Studies
  • Viral Proteins
  • Young Adult

Substances

  • Antibodies, Viral
  • Immunoglobulin G
  • Viral Proteins