Engineering luminescent biosensors for point-of-care SARS-CoV-2 antibody detection.

Elledge, Susanna K; Zhou, Xin X; Byrnes, James R; Martinko, Alexander J; Lui, Irene; Pance, Katarina; Lim, Shion A; Glasgow, Jeff E; Glasgow, Anum A; Turcios, Keirstinne; Iyer, Nikita S; Torres, Leonel; Peluso, Michael J; Henrich, Timothy J; Wang, Taia T; Tato, Cristina M; Leung, Kevin K; Greenhouse, Bryan; Wells, James A

Current serology tests for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies mainly take the form of enzyme-linked immunosorbent assays, chemiluminescent microparticle immunoassays or lateral flow assays, which are either laborious, expensive or lacking sufficient sensitivity and scalability. Here we present the development and validation of a rapid, low-cost, solution-based assay to detect antibodies in serum, plasma, whole blood and to a lesser extent saliva, using rationally designed split luciferase antibody biosensors. This new assay, which generates quantitative results in 30 min, substantially reduces the complexity and improves the scalability of coronavirus disease 2019 (COVID-19) antibody tests. This assay is well-suited for point-of-care, broad population testing, and applications in low-resource settings, for monitoring host humoral responses to vaccination or viral infection.