High-Throughput Neutralization and Serology Assays Reveal Correlated but Highly Variable Humoral Immune Responses in a Large Population of Individuals Infected with SARS-CoV-2 in the US between March and August 2020
Shuting Zhang, Peijun Ma, Marek Orzechowski, Allison Lemmer, Kara M. Rzasa, Josephine Bagnall, Sulyman Barkho, Michael Chen, Lorrie L. He, Raymond Neitupski, Victoria M. Tran, Ross Ackerman, Emily Gath, Austin Bond, Giana Frongillo, Thomas A. Cleland, Aaron Golas, Anthony O. Gaca, Michael G. FitzGerald, Kathleen Kelly, Kelsey Hazegh, Larry J. Dumont, Corey M. Hoffman, Mary J. Homer, Peter Marks, Ann E. Woolley, Sharon Y. Wong, James Gomez, Jonathan Livny, Deborah T. Hung
Abstract
The ability to directly measure neutralizing antibodies on live SARS-CoV-2 virus in individuals can play an important role in understanding the efficacy of therapeutic interventions or vaccines. In contrast to functional neutralization assays, serological assays only quantify the presence of antibodies as a proxy of immune protection. Here, we have developed a high-throughput, automated neutralization assay for SARS-CoV-2 and measured the neutralizing activity of ~19,000 COVID-19 convalescent plasma (CCP) samples collected across the United States between March and August of 2020. These data were used to support the FDA's interpretation of CCP efficacy in patients with SARS-CoV-2 infection and their issuance of emergency use authorization of CCP in 2020.