dbGaP Study Accession: phs002544

NIH Institute/Center: NCATS

RADx Data Program: RADx-rad

Release Date: 01/26/2022

DOI: 10.60773/w5vb-c640

Updated Date: 09/27/2023

Study Description: This project was in response to the NIH's RADx-rad Emergency Responses to the COVID-pandemic for new or non-traditional technologies developed for single extracellular vesicle, exosome and extracellular RNA (exRNA) isolation and analysis and reposition them for detection of SARS-CoV-2. The project's group was a grantee in the NIH Common Fund Extracellular RNA Communication (ERC) Program advancing a new and emerging technology of Acoustofluidic Separation (AFS) for label-free, high yield and purity exosomes from biofluids which is coupled to extracellular RNA characterization using Surface Enhanced Raman Spectroscopy (SERS) for single EV identification. This project was to reposition the AFS EV technology and SERS for the non-invasive earliest detection of SARS-CoV-2 in saliva of infected patients. Host immunity to SARS-CoV-2 was also assessed in the saliva samples, permitting the earliest detection of SARS-CoV-2 infection and host immunity non-invasively in a saliva sample.

Principal Investigator: Wong, David T

Has Data Files: Yes

Study Domain: Virological Testing; Medical Device/Tool Development

Data Collection Method: Molecular (Nucleic Acid/PCR) Testing Device

Keywords: Host Immunity; Exosome based; Early Detection; Electric Field–Induced Release and Measurement (EFIRM); Surface Enhanced Raman Spectroscopy (SERS)

Study Design: Device Validation Study

Multi-Center Study: FALSE

Data Types: Clinical; Immunological

Study Start Date: 12/21/2020

Study End Date: 11/30/2022

Species: Human Data

Estimated Cohort Size: 90

Study Population Focus: N/A

Acknowledgement Statement: This study was supported through funding, 4U18TR003778-02, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002544.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.

Funding Opportunity Announcement (FOA) Number: RFA-OD-20-018

NIH Grant or Contract Number(s): 4U18TR003778-02

Consent/Data Use Limitations: General Research Use