Standardization of in-house anti-IgG and IgA ELISAs for the detection of COVID-19

PLoS One. 2023 Jun 9;18(6):e0287107. doi: 10.1371/journal.pone.0287107. eCollection 2023.

Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the causative agent of coronavirus disease 2019 (COVID-19). RT-PCR detection of viral RNA represents the gold standard method for diagnosis of COVID-19. However, multiple diagnostic tests are needed for acute disease diagnosis and assessing immunity during the COVID-19 outbreak. Here, we developed in-house anti-RBD IgG and IgA enzyme-linked immunosorbent assays (ELISAs) using a well-defined serum sample panel for screening and identification of human SARS-CoV-2 infection. We found that our in-house anti-SARS-CoV-2 IgG ELISA displayed a 93.5% sensitivity and 98.8% specificity whereas our in-house anti-SARS-CoV-2 IgA ELISA provided assay sensitivity and specificity at 89.5% and 99.4%, respectively. The agreement kappa values of our in-house anti-SARS-CoV-2 IgG and IgA ELISA assays were deemed to be excellent and fair, respectively, when compared to RT-PCR and excellent for both assays when compared to Euroimmun anti-SARS-CoV-2 IgG and IgA ELISAs. These data indicate that our in-house anti-SARS-CoV-2 IgG and IgA ELISAs are compatible performing assays for the detection of SARS-CoV-2 infection.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Antibodies, Viral
  • COVID-19 Testing
  • COVID-19* / diagnosis
  • Clinical Laboratory Techniques / methods
  • Enzyme-Linked Immunosorbent Assay / methods
  • Humans
  • Immunoglobulin A
  • Immunoglobulin G
  • Immunoglobulin M
  • Reference Standards
  • SARS-CoV-2
  • Sensitivity and Specificity

Substances

  • anti-IgG
  • Antibodies, Viral
  • Immunoglobulin G
  • Immunoglobulin A
  • Immunoglobulin M

Grants and funding

This work was supported by Armed Forces Health Surveillance Branch (AFHSB) and its Global Emerging Infectious Surveillance (GEIS) Section, United States, under grant number P0021_22_AF for the fiscal year 2022 to ARJ. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.