Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) qualitative immunoglobulin g assays the value of numeric reporting

Stefanie K. Forest, Erika P. Orner, D. Yitzchak Goldstein, Ariel S. Wirchnianski, Robert H. Bortz, Ethan Laudermilch, Catalina Florez, Ryan J. Malonis, George I. Georgiev, Olivia Vergnolle, Yungtai Lo, Sean T. Campbell, Jason Barnhill, Evan M. Cadoff, Jonathan R. Lai, Kartik Chandran, Louis M. Weiss, Amy S. Fox, Michael B. Prystowsky, Lucia R. Wolgast

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Context.-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoglobulin G (IgG) testing is used for serosurveillance and will be important to evaluate vaccination status. Given the urgency to release coronavirus disease 2019 (COVID-19) serology tests, most manufacturers have developed qualitative tests. Objective.-To evaluate clinical performance of 6 different SARS-CoV-2 IgG assays and their quantitative results to better elucidate the clinical role of serology testing in COVID-19. Design.-Six SARS-CoV-2 IgG assays were tested using remnant specimens from 190 patients. Sensitivity and specificity were evaluated for each assay with the current manufacturer's cutoff and a lower cutoff. A numeric result analysis and discrepancy analysis were performed. Results.-Specificity was higher than 93% for all assays, and sensitivity was higher than 80% for all assays (≥7 days post-polymerase chain reaction testing). Inpatients with more severe disease had higher numeric values compared with health care workers with mild or moderate disease. Several discrepant serology results were those just below the manufacturers' cutoff. Conclusions.-Severe acute respiratory syndrome coronavirus 2 IgG antibody testing can aid in the diagnosis of COVID-19, especially with negative polymerase chain reaction. Quantitative COVID-19 IgG results are important to better understand the immunologic response and disease course of this novel virus and to assess immunity as part of future vaccination programs.

Original languageEnglish (US)
Pages (from-to)929-936
Number of pages8
JournalArchives of Pathology and Laboratory Medicine
Issue number8
StatePublished - Aug 2021

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology


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