Exosome-based Non-traditional Technologies Towards Multi-Parametric andIntegrated Approaches for SARS-CoV-2

Abstract This supplement is in response to Funding Opportunity Announcement Number PA-20-272 Administrative Supplements to Existing NIH Grants and Cooperative Agreements. The supplement application is in response to the RADx-rad announcement on the opportunity of additional resources and funding support to facilitate the pathway to commercialization. The opportunity was announced by the RADx-rad Data Coordination Center (DCC) and relayed through the NIH SEED office. The urgent need to curb the spread of SARS-CoV-2 demands availability of diagnostics that are more rapid, accurate, sensitive and affordable than qPCR and antibody tests. Current qPCR tests are specific and sensitive, but lengthy turnaround times limit interventions against disease spread. Antibody testing is faster, but false-positive/negative rates are high. Here, we propose to repurpose extracellular vesicle (EV) separation and characterization technologies into a fully automated SARS-CoV-2 testing platform that is low-cost, accurate, sensitive, rapid (within 5 min), and practical. The device has been optimized to analyze blood, saliva, and nasopharyngeal (NP) swabs. However, in this proposal we will be focusing on saliva or drooling samples (25-50 ul) that can be easily self-obtained at-home setting. The sample is processed with an automated device developed with Sognef Inc., and data are transferred to the Sognef servers for analysis through an app that can be downloaded to any smart device. This technology is similar to Abbott's recently launched BinaxNOW COVID-19 Ag Card, but has the advantage of multiparametric detection of viral RNA (vRNA), including Spike (S) and Nucleocapsid (N) protein-coding regions that reveals infection even when viral loads are below detectable limits. This approach will decrease false- positives/negatives, the major limitation of antigen/antibody tests.