Comparison of the clinical performance and usefulness of five SARS-CoV-2 antibody tests

PLoS One. 2021 Feb 8;16(2):e0246536. doi: 10.1371/journal.pone.0246536. eCollection 2021.

Abstract

We examined the usefulness of five COVID-19 antibody detection tests using 114 serum samples at various time points from 34 Japanese COVID-19 patients. We examined Elecsys Anti-SARS-CoV-2 from Roche, and four immunochromatography tests from Hangzhou Laihe Biotech, Artron Laboratories, Chil, and Nadal. In the first week after onset, Elecsys had 40% positivity in Group S (severe cases) but was negative in Group M (mild-moderate cases). The immunochromatography kits showed 40-60% and 0-8% positivity in Groups S and M, respectively. In the second week, Elecsys showed 75% and 50% positivity, and the immunochromatography tests showed 5-80% and 50-75% positivity in Groups S and M, respectively. After the third week, Elecsys showed 100% positivity in both groups. The immunochromatography kits showed 100% positivity in Group S. In Group M, positivity decreased to 50% for Chil and 75-89% for Artron and Lyher. Elecsys and immunochromatography kits had 91-100% specificity. Elecsys had comparable chronological change of cut-off index values in the two groups from the second week to the sixth week. The current SARS-CoV-2 antibody detection tests do not provide meaningful interpretation of severity and infection status. Its use might be limited to short-term epidemiological studies.

Publication types

  • Comparative Study

MeSH terms

  • Adult
  • Aged
  • Antibodies, Viral / immunology*
  • COVID-19 / diagnosis*
  • COVID-19 / immunology*
  • COVID-19 / virology
  • COVID-19 Serological Testing / methods*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Reagent Kits, Diagnostic
  • SARS-CoV-2 / physiology
  • Sensitivity and Specificity

Substances

  • Antibodies, Viral
  • Reagent Kits, Diagnostic

Grants and funding

Reagents and assays for Elecsys Anti-SARS-CoV-2 were provided by Roche Diagnostics. LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test, Artron COVID-19 IgM/IgG Antibody Test, CHIL COVID-19 IgG/IgM Rapid Test, and NADAL COVID-19 IgG/IgM test were provided by Hangzhou Laihe Biotech, Artron Laboratories, Chil, and nal von minden, respectively. All providers did not play any roles in the design of the study, analysis and interpretation of the data.