@article{e2cbaf569189444788910a4c9d062776,
title = "Direct capture of neutralized RBD enables rapid point-of-care assessment of SARS-CoV-2 neutralizing antibody titer",
abstract = "Neutralizing antibody (NAb) titer is a key biomarker of protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, but point-of-care methods for assessing NAb titer are not widely available. Here, we present a lateral flow assay that captures SARS-CoV-2 receptor-binding domain (RBD) that has been neutralized from binding angiotensin-converting enzyme 2 (ACE2). Quantification of neutralized RBD in this assay correlates with NAb titer from vaccinated and convalescent patients. This methodology demonstrated superior performance in assessing NAb titer compared with either measurement of total anti-spike immunoglobulin G titer or quantification of the absolute reduction in binding between ACE2 and RBD. Our testing platform has the potential for mass deployment to aid in determining at population scale the degree of protective immunity individuals may have following SARS-CoV-2 vaccination or infection and can enable simple at-home assessment of NAb titer.",
keywords = "ACE2, LFA, POC diagnostics, RBD, SARS-CoV-2, neutralizing antibodies",
author = "Connelly, {Guinevere G.} and Kirkland, {Orville O.} and Seven Bohannon and Lim, {Daniel C.} and Wilson, {Robert M.} and Richards, {Edward J.} and Tay, {Dousabel M.} and Hyuk Jee and Hellinger, {Riley D.} and Hoang, {Ngoc K.} and Liang Hao and Arnav Chhabra and Carmen Martin-Alonso and Tan, {Edward K.W.} and Koehler, {Angela N.} and Yaffe, {Michael B.} and London, {Wendy B.} and Lee, {Pui Y.} and Florian Krammer and Bohannon, {Robert C.} and Bhatia, {Sangeeta N.} and Sikes, {Hadley D.} and Hojun Li",
note = "Funding Information: The authors would like to thank Gail Bell, Tatum Braun, Christopher Nabel, Sharon Onggo, and Katherine Waters for technical assistance and Salil Garg for helpful discussion. This work was supported in part by the Koch Institute Support Core grant P30-CA14051 from the National Cancer Institute . We thank the Koch Institute{\textquoteright}s Robert A. Swanson (1969) Biotechnology Center for technical support, specifically the Flow Cytometry Core. H.L. is supported by the Charles W. (1955) and J ennifer C. Johnson Cancer Research Fund, an American Society of Hematology Scholar award, and a National Institutes of Health grant K08-DK123414 . D.C.L. and M.B.Y. are supported in part by the Charles and Marjorie Holloway Foundation . Funding Information: The authors would like to thank Gail Bell, Tatum Braun, Christopher Nabel, Sharon Onggo, and Katherine Waters for technical assistance and Salil Garg for helpful discussion. This work was supported in part by the Koch Institute Support Core grant P30-CA14051 from the National Cancer Institute. We thank the Koch Institute's Robert A. Swanson (1969) Biotechnology Center for technical support, specifically the Flow Cytometry Core. H.L. is supported by the Charles W. (1955) and Jennifer C. Johnson Cancer Research Fund, an American Society of Hematology Scholar award, and a National Institutes of Health grant K08-DK123414. D.C.L. and M.B.Y. are supported in part by the Charles and Marjorie Holloway Foundation. G.G.C. O.O.K. S.B. D.C.L. R.M.W. E.J.R. D.M.T. L.H. A.C. C.M.-A. E.K.W.T. M.B.Y. R.C.B. H.D.S. and H.L. designed the research, reagents, and prototype. G.G.C. O.O.K. S.B. D.C.L. R.M.W. E.J.R. H.J. R.D.H. N.K.H. W.B.L. P.Y.L. F.K. R.C.B. and H.L. generated the reagents and prototype, performed the research, and analyzed the data. A.N.K. M.B.Y. P.Y.L. R.C.B. S.N.B. H.D.S. and H.L. supervised the work and obtained funding. All authors contributed to writing and editing the manuscript. S.B. and R.C.B. were employees of Catalloid Products when this work was performed. As of December 1, 2020, E.J.R. is an employee of Dragonfly Therapeutics. As of February 1, 2021, A.C. is an employee of Satellite Bio. The Massachusetts Institute of Technology has filed patents related to this technology on behalf of G.G.C. and H.L. The Icahn School of Medicine at Mount Sinai has filed patent applications relating to SARS-CoV-2 serological assays and NDV-based SARS-CoV-2 vaccines, which list F.K. as co-inventor. Mount Sinai has spun out a company, Kantaro, to market serological tests for SARS-CoV-2. F.K. has consulted for Merck and Pfizer (before 2020) and is currently consulting for Pfizer, Third Rock Ventures, Seqirus, and Avimex. The F.K. laboratory is also collaborating with Pfizer on animal models of SARS-CoV-2. As of August 23, 2021, G.G.C. is affiliated with Duke University. As of July 1, 2022, R.D.H. is affiliated with University of Arizona College of Medicine at Tucson. As of August 31, 2021, H.J. is affiliated with Dartmouth University. Publisher Copyright: {\textcopyright} 2022 The Author(s)",
year = "2022",
month = aug,
day = "22",
doi = "10.1016/j.crmeth.2022.100273",
language = "English",
volume = "2",
journal = "Cell Reports Methods",
issn = "2667-2375",
publisher = "Cell Press",
number = "8",
}