AUTHOR=Sherman Amy C. , Smith Teresa , Zhu Yerun , Taibl Kaitlin , Howard-Anderson Jessica , Landay Taylor , Pisanic Nora , Kleinhenz Jennifer , Simon Trevor W. , Espinoza Daniel , Edupuganti Neena , Hammond Skyler , Rouphael Nadine , Shen Huifeng , Fairley Jessica K. , Edupuganti Srilatha , Cardona-Ospina Jaime A. , Rodriguez-Morales Alfonso J. , Premkumar Lakshmanane , Wrammert Jens , Tarleton Rick , Fridkin Scott , Heaney Christopher D. , Scherer Erin M. , Collins Matthew H. 

TITLE=Application of SARS-CoV-2 Serology to Address Public Health Priorities

JOURNAL=Frontiers in Public Health

VOLUME=9

YEAR=2021

URL=https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2021.744535

DOI=10.3389/fpubh.2021.744535

ISSN=2296-2565

ABSTRACT=<p><bold>Background:</bold> Antibodies against SARS-CoV-2 can be detected by various testing platforms, but a detailed understanding of assay performance is critical.</p><p><bold>Methods:</bold> We developed and validated a simple enzyme-linked immunosorbent assay (ELISA) to detect IgG binding to the receptor-binding domain (RBD) of SARS-CoV-2, which was then applied for surveillance. ELISA results were compared to a set of complimentary serologic assays using a large panel of clinical research samples.</p><p><bold>Results:</bold> The RBD ELISA exhibited robust performance in ROC curve analysis (AUC&gt; 0.99; Se = 89%, Sp = 99.3%). Antibodies were detected in 23/353 (6.5%) healthcare workers, 6/9 RT-PCR-confirmed mild COVID-19 cases, and 0/30 non-COVID-19 cases from an ambulatory site. RBD ELISA showed a positive correlation with neutralizing activity (<italic>p</italic> = &lt;0.0001, <italic>R</italic><sup>2</sup> = 0.26).</p><p><bold>Conclusions:</bold> We applied a validated SARS-CoV-2-specific IgG ELISA in multiple contexts and performed orthogonal testing on samples. This study demonstrates the utility of a simple serologic assay for detecting prior SARS-CoV-2 infection, particularly as a tool for efficiently testing large numbers of samples as in population surveillance. Our work also highlights that precise understanding of SARS-CoV-2 infection and immunity at the individual level, particularly with wide availability of vaccination, may be improved by orthogonal testing and/or more complex assays such as multiplex bead assays.</p>