Development of a Rapid Point-Of-Care Test that Measures Neutralizing Antibodies to SARS-CoV-2

Lake, D. F.; Roeder, A. J.; Kaleta, E.; Jasbi, P.; Periasamy, S.; Kuzmina, N.; Bukreyev, A.; Grys, T. E.; Wu, L.; Mills, J. R.; McAulay, K.; Seit-Nebi, A.; Svarovsky, S.

As increasing numbers of people recover from and are vaccinated against COVID-19, tests are needed to measure levels of protective, neutralizing antibodies longitudinally to help determine duration of immunity. We developed a lateral flow assay (LFA) that measures levels of neutralizing antibodies in plasma, serum or whole blood. The LFA is based on the principle that neutralizing antibodies inhibit binding of the spike protein receptor-binding domain (RBD) to angiotensin-converting enzyme 2 (ACE2). The test classifies high levels of neutralizing antibodies in sera that were titered using authentic SARS-CoV-2 and pseudotype neutralization assays with an accuracy of 98%. Sera obtained from patients with seasonal coronavirus did not prevent RBD from binding to ACE2. As a demonstration for convalescent plasma therapy, we measured conversion of non-immune plasma into strongly neutralizing plasma. This is the first report of a neutralizing antibody test that is rapid, highly portable and relatively inexpensive that might be useful in assessing COVID-19 vaccine immunity.