A Novel Adaptive Platform for Rapid, Simple Flow-Based Antibody Detection Devices Predicts NAb Levels to SARS-CoV-2

Andreas Markmann; D. Ryan Bhowmik; Baowei Jiang; Usaphea Vanna; Michael Van Hoy; Frank Wang; Yixuan Hou; David Margolis; Ralph Baric; Aravinda de Silva; Luther Bartelt

doi:10.20411/pai.v11i1.910

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Published: Feb 16, 2026

DOI: https://doi.org/10.20411/pai.v11i1.910

Keywords:

Rapid Diagnostic, COVID-19 Immunity, SARS-CoV-2, Antibody Response, Neutralizing Antibodies, Correlate of Immune Protection

Alena J. Markmann

Department of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, North Carolina

D. Ryan Bhowmik

Department of Microbiology and Immunology, University of North Carolina School of Medicine, Chapel Hill, North Carolina; Current affiliation: Institute of Bioinformatics, University of Georgia, Athens, Georgia

Baowei Jiang

BioMedomics Inc., Morrisville, North Carolina

Usaphea P. Vanna

Department of Pharmacology, University of North Carolina at Chapel Hill, North Carolina

Michael Van Hoy

BioMedomics Inc., Morrisville, North Carolina; Current affiliation: Transformative Legal, LLC., Scottsdale, Arizona

Frank Wang

BioMedomics Inc., Morrisville, North Carolina

Yixuan J. Hou

Department of Epidemiology, School of Public Health, University of North Carolina, Chapel Hill, North Carolina; Current affiliation: Moderna Therapeutics Inc., Cambridge, Massachusetts

David M. Margolis

Department of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine; Department of Microbiology and Immunology, University of North Carolina School of Medicine; UNC HIV Cure Center, University of North Carolina School of Medicine, Chapel Hill, North Carolina

Ralph S. Baric

Department of Microbiology and Immunology, University of North Carolina School of Medicine; Current affiliation: Transformative Legal, LLC., Scottsdale, Arizona

Aravinda M. de Silva

Department of Microbiology and Immunology, University of North Carolina School of Medicine, Chapel Hill, North Carolina

Luther A. Bartelt

Department of Medicine, Division of Infectious Diseases, University of North Carolina School of Medicine; Department of Microbiology and Immunology, University of North Carolina School of Medicine, Chapel Hill, North Carolina

Abstract

Background: COVID-19 has caused millions of deaths and continues to burden individuals and the healthcare system. Antibodies that neutralize SARS-CoV-2 have proven to be the most reliable markers of immune protection, targets for vaccine development, and approaches for anti-viral antibody-based therapies. Measuring neutralizing antibody (NAb) titers at the bedside could inform individualized shared decision-making with patients regarding the potential benefits of repeating vaccines, use of preventative or therapeutic antibody-based therapies, and, where relevant, collection of COVID-19 convalescent plasma (CCP) with greater efficacy, especially as NAb-escape mutations have guided SARS-CoV-2 variant emergence. However, specific and accessible assays to quantify NAb levels in individuals, including the identification of potential antibody donors at the time of donation, remain unavailable. Therefore, there is a need for platforms that can be rapidly adapted to quantify serum antibody responses with known or expected correlates of protection.

Methods: In this report, we apply a novel semi-quantitative method to an established antibody lateral flow assay (sqLFA) and analyze its ability to detect the presence of functional NAbs in the serum of COVID-19-recovered individuals early in the pandemic.

Results: We found that the sqLFA has a strong positive correlation with the gold-standard microneutralization assay (specificity 80% and sensitivity 90% at a microneutralization cutoff of 1:40).

Conclusions: Taken together, the sqLFA provides a novel point-of-care-based platform for rapid readout of NAb-based immune protection to SARS-CoV-2.

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