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

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.