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

• Published in: Journal of clinical microbiology Vol. 59; no. 4
• Main Authors: Taylor, Sean C., Hurst, Beth, Charlton, Carmen L., Bailey, Ashley, Kanji, Jamil N., McCarthy, Mary K., Morrison, Thomas E., Huey, Leah, Annen, Kyle, DomBourian, Melkon G., Knight, Vijaya
• Format: Journal Article
• Language: English
• Published: United States American Society for Microbiology 19.03.2021
• Subjects: Virology; neutralizing antibodies; SARS-CoV-2; vaccines; serology; ELISA
• ISSN: 0095-1137; 1098-660X; 1098-660X
• DOI: 10.1128/JCM.02438-20

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. 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.