AFS/SERS Saliva-based SARS-CoV-2 Earliest Infection and Antibodies Detection

Project Summary/Abstract: This U18 application is responsive to the NIH's RADx-rad Emergency Responses to the COVID-pandemic for new or non-traditional technologies developed for single extracellular vesicle, exosome andextracellular RNA (exRNA) isolation and analysis and reposition them for detection of SARS-CoV-2. Theapplicant's group is a grantee in the NIH Common Fund "Extracellular RNA Communication (ERC)" Programadvancing a new and emerging technology of Acoustofluidic Separation (AFS) for label-free, high yield and purityexosomes from biofluids which is coupled to extracellular RNA characterization using Surface Enhanced RamanSpectroscopy (SERS) for single EV identification. This U18 application is to reposition the AFS EV technologyand SERS for the non-invasive earliest detection of SARS-CoV-2 in saliva of infected patients. Host immunity toSARS-CoV-2 will also be assessed in the saliva samples, permitting the earliest detection of SARS-CoV-2infection and host immunity non-invasively in a saliva sample. Five Specific Aims are in place to reposition the saliva-based AFS and SERS technologies, in a 2-yearU18 proposal, to test the hypothesis that an integrated multi-parametric non-invasive saliva test for SARS-CoV-2 infection, viral load and host immunity test demonstrating clinical performance surpassing current saliva-basedSARS-CoV-2 EUA tests.