INTRODUCTION

AffinityImmuno Inc.’s SARS-CoV-2 spike protein-ligand binding assay (surrogate Virus Neutralization Test) allows rapid quantification of COVID-19 neutralizing antibodies in serum and plasma by measuring the reduction in binding of viral spike protein with its receptor ACE2. This assay allows rapid analysis of convalescent plasma, antibody-based therapeutics, vaccine leads, and immune response to the virus to measure the percent reduction in spike protein binding to ACE2. This serological platform was designed as a tool to understand the correlation between neutralizing antibody level and protective immunity in recovered SARS-CoV-2.

This product helps to identify the presence of SARS-CoV-2 / COVID-19 neutralizing antibodies via surrogate virus neutralization testing (SVNT). This process is able to be conducted quickly in comparison to other detection methods such as Plaque Reduction Neutralization Test (PRNT) or similar cell culture based tests that take multiple days to perform. The AffinityImmuno sVNT test has a number of applications including convalescent plasma screening, vaccine response testing, small molecule ligand screening, and monitoring population immunity that could help to combat the global SARS-CoV-2 / COVID-19 pandemic.

Comparison of 62 serum samples from recovered, COVID-19 individuals to 260 non-COVID-19 (self-declared) individuals demonstrates the presence of virus neutralizing antibodies that prevent binding between the spike protein and its receptor, ACE2.