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Article

A Strategy to Detect Emerging Non-Delta SARS-CoV-2 Variants with a Monoclonal Antibody Specific for the N501 Spike Residue

1
Center for Human Antibody Technology, Lankenau Institute for Medical Research, Wynnewood, PA 19096, USA
2
Department of Microbiology and Immunology, Thomas Jefferson University, Philadelphia, PA 19107, USA
3
Nicoya Lifesciences, Kitchener, ON N2G 2K4, Canada
4
Department of Internal Medicine, Lankenau Medical Center, Wynnewood, PA 19096, USA
5
Debina Diagnostics, Newtown Square, PA 19073, USA
6
Pro-SPR, 52477 Alsdorf, Germany
*
Author to whom correspondence should be addressed.
Current email: [email protected].
Academic Editor: Anna Baraniak
Diagnostics 2021, 11(11), 2092; https://doi.org/10.3390/diagnostics11112092
Received: 22 October 2021 / Revised: 8 November 2021 / Accepted: 9 November 2021 / Published: 12 November 2021
Efforts to control SARS-CoV-2 have been challenged by the emergence of variant strains that have important implications for clinical and epidemiological decision making. Four variants of concern (VOCs) have been designated by the Centers for Disease Control and Prevention (CDC), namely, B.1.617.2 (delta), B.1.1.7 (alpha), B.1.351 (beta), and P.1 (gamma), although the last three have been downgraded to variants being monitored (VBMs). VOCs and VBMs have shown increased transmissibility and/or disease severity, resistance to convalescent SARS-CoV-2 immunity and antibody therapeutics, and the potential to evade diagnostic detection. Methods are needed for point-of-care (POC) testing to rapidly identify these variants, protect vulnerable populations, and improve surveillance. Antigen-detection rapid diagnostic tests (Ag-RDTs) are ideal for POC use, but Ag-RDTs that recognize specific variants have not yet been implemented. Here, we describe a mAb (2E8) that is specific for the SARS-CoV-2 spike protein N501 residue. The 2E8 mAb can distinguish the delta VOC from variants with the N501Y meta-signature, which is characterized by convergent mutations that contribute to increased virulence and evasion of host immunity. Among the N501Y-containing mutants formerly designated as VOCs (alpha, beta, and gamma), a previously described mAb, CB6, can distinguish beta from alpha and gamma. When used in a sandwich ELISA, these mAbs sort these important SARS-CoV-2 variants into three diagnostic categories, namely, (1) delta, (2) alpha or gamma, and (3) beta. As delta is currently the predominant variant globally, they will be useful for POC testing to identify N501Y meta-signature variants, protect individuals in high-risk settings, and help detect epidemiological shifts among SARS-CoV-2 variants. View Full-Text
Keywords: COVID-19; SARS-CoV-2; delta variant; variants of concern; clinical diagnostic test; monoclonal antibody; OCMS™ COVID-19; SARS-CoV-2; delta variant; variants of concern; clinical diagnostic test; monoclonal antibody; OCMS™
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MDPI and ACS Style

Puligedda, R.D.; Al-Saleem, F.H.; Wirblich, C.; Kattala, C.D.; Jović, M.; Geiszler, L.; Devabhaktuni, H.; Feuerstein, G.Z.; Schnell, M.J.; Sack, M.; Livornese, L.L., Jr.; Dessain, S.K. A Strategy to Detect Emerging Non-Delta SARS-CoV-2 Variants with a Monoclonal Antibody Specific for the N501 Spike Residue. Diagnostics 2021, 11, 2092. https://doi.org/10.3390/diagnostics11112092

AMA Style

Puligedda RD, Al-Saleem FH, Wirblich C, Kattala CD, Jović M, Geiszler L, Devabhaktuni H, Feuerstein GZ, Schnell MJ, Sack M, Livornese LL Jr., Dessain SK. A Strategy to Detect Emerging Non-Delta SARS-CoV-2 Variants with a Monoclonal Antibody Specific for the N501 Spike Residue. Diagnostics. 2021; 11(11):2092. https://doi.org/10.3390/diagnostics11112092

Chicago/Turabian Style

Puligedda, Rama Devudu, Fetweh H. Al-Saleem, Cristoph Wirblich, Chandana Devi Kattala, Marko Jović, Laura Geiszler, Himani Devabhaktuni, Giora Z. Feuerstein, Matthias J. Schnell, Markus Sack, Lawrence L. Livornese Jr., and Scott K. Dessain. 2021. "A Strategy to Detect Emerging Non-Delta SARS-CoV-2 Variants with a Monoclonal Antibody Specific for the N501 Spike Residue" Diagnostics 11, no. 11: 2092. https://doi.org/10.3390/diagnostics11112092

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