An immunity screen assessing covid-19 and vaccination induced antibody response at point-of-care Kritika Srinivasan 1, 2 , Glennon W. Simmons 1 , Michael P. McRae 1 , Nicolaos J. Christodoulides 1 , John T. McDevitt 1 * 1 Department of Molecular Pathobiology, Division of Biomaterials, Bioengineering Institute, New York University College of Dentistry, USA, 2 Department of Pathology, Vilcek Institute, New York University School of Medicine, USA Coronavirus Disease – 2019 (COVID-19) has currently infected over 470 million people, leading to over 6 million deaths, worldwide. While COVID-19 vaccines are demonstrating robust seroconversion and disease prevention towards the fight to curtail this pandemic, accurate diagnosis of the causative agent – SARS-CoV-2 remains a key pillar to disease detection and monitoring. Antigen, antibody and molecular diagnostic testing have been used widely, but the virus continues to evolve in parallel, even as the society is pushing to achieve mass immunity - through vaccination, in addition to antibody response achieved post-infection. Individuals with immune compromise and suppression have been shown to have less than anticipated antibody response to COVID immunization, thus affecting their ability to mitigate disease. Understanding and quantitatively screening immune response is highly valuable not just in these individuals, but also for healthy populations. Sero-surveillance have insightful applications in diagnostics, relating to COVID vaccination and/or infection translated immune response. This information can help clinicians and scientists strategize vaccination dosage and therapeutics to mitigate disease risk and add essential value to vaccine perception and reception. In this context, a quantitative serological assay, available at the point-of-care (POC), that measures anti- SARS-CoV-2 antibodies is beneficial to help screen the immune response in individuals’ post vaccination and/ or infection. Additionally, as vaccination continues to be implemented, rapid, accurate and quantitative POC COVID-19 testing remains critical for return to in-person operations. Utilizing an in-house lab-on a chip ecosystem, herein we present the proof-of-concept, optimization and validation of a POC strategy that quantitates the COVID-19 immunity screening. This platform covers the entire diagnostic timeline of the disease, seroconversion, and vaccination response spanning across single and multi-dosed vaccines - all in a single POC test. Initial test results demonstrate that this platform is rapid (~15 min), quantitative, and sensitive for SARS-CoV-2 specific IgG.
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