A New SARS-CoV-2 Dual-Purpose Serology Test: Highly Accurate Infection Tracing and Neutralizing Antibody Response Detection

Sean C Taylor; Beth Hurst; Carmen L Charlton; Ashley Bailey; Jamil N Kanji; Mary K McCarthy; Thomas E Morrison; Leah Huey; Kyle Annen; Melkon G DomBourian; Vijaya Knight

doi:10.1128/JCM.02438-20

A New SARS-CoV-2 Dual-Purpose Serology Test: Highly Accurate Infection Tracing and Neutralizing Antibody Response Detection

J Clin Microbiol. 2021 Mar 19;59(4):e02438-20. doi: 10.1128/JCM.02438-20. Print 2021 Mar 19.

Authors

Sean C Taylor¹, Beth Hurst², Carmen L Charlton^{3

4

5}, Ashley Bailey³, Jamil N Kanji^{3

6}, Mary K McCarthy⁷, Thomas E Morrison⁷, Leah Huey^{8

9}, Kyle Annen^{10

11}, Melkon G DomBourian^{10

11}, Vijaya Knight^{8

9}

Affiliations

¹ GenScript USA Inc., Piscataway, New Jersey, USA sean.taylor@genscript.com.
² Cayman Chemical, Ann Arbor, Michigan, USA.
³ Public Health Laboratory, Alberta Precision Laboratories (ProvLab), University of Alberta Hospital, Edmonton, AB, Canada.
⁴ Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
⁵ Li Ka Shing Institute of Virology, University of Alberta, Edmonton, AB, Canada.
⁶ Division of Infectious Diseases, Department of Medicine, University of Alberta, Edmonton, AB, Canada.
⁷ Department of Immunology and Microbiology, University of Colorado School of Medicine, Aurora, Colorado, USA.
⁸ Department of Pediatrics, University of Colorado School of Medicine, Aurora, Colorado, USA.
⁹ Department of Pediatrics, Children's Hospital Colorado Anschutz Medical Campus, Aurora, Colorado, USA.
¹⁰ Department of Pathology and Laboratory Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
¹¹ Department of Pathology and Laboratory Medicine, Children's Hospital Colorado Anschutz Medical Campus, Aurora, Colorado, USA.

Abstract

Many severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology tests have proven to be less accurate than expected and do not assess antibody function as neutralizing, correlating with protection from reinfection. A new assay technology measuring the interaction of the purified SARS-CoV-2 spike protein receptor binding domain (RBD) with the extracellular domain of the human angiotensin-converting enzyme 2 (hACE2) receptor detects these important antibodies. The cPass surrogate virus neutralization test (sVNT), compared directly with eight SARS-CoV-2 IgG serology and two live-cell neutralization tests, gives similar or improved accuracy for qualitative delineation between positive and negative individuals in a fast, scalable, and high-throughput assay. The combined data support the cPass sVNT as a tool for highly accurate SARS-CoV-2 immunity surveillance of infected/recovered and/or vaccinated individuals as well as drug and convalescent-phase donor screening. The data also preview a novel application for the cPass sVNT in calibrating the stringency of live-cell neutralization tests and its use in longitudinal testing of recovered and/or vaccinated patients.

Keywords: ELISA; SARS-CoV-2; neutralizing antibodies; serology; vaccines.

MeSH terms

Antibodies, Neutralizing*
Antibodies, Viral
COVID-19*
Humans
SARS-CoV-2
Spike Glycoprotein, Coronavirus / genetics

Substances

Antibodies, Neutralizing
Antibodies, Viral
Spike Glycoprotein, Coronavirus
spike protein, SARS-CoV-2