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

Many 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 purified SARS CoV-2 spike protein receptor binding domain (RBD) with the extracellular domain of the human ACE2 receptor detects these important antibodies. This cPassTM surrogate virus neutralization test (sVNT) when 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 cPassTM 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 donor screening. The data also prevue a novel application for cPassTM sVNT in calibrating the stringency of live cell neutralization tests and its use in longitudinal testing of recovered and/or vaccinated patients.