dbGaP Study Accession: phs002709

NIH Institute/Center: NCATS

RADx Data Program: RADx-rad

Release Date: 07/25/2022

DOI: 10.60773/ws7v-2r18

Study Description: COVID-19, a global pandemic due to its rapid progression, is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). There are different assays for COVID-19 testing, including nucleic acid, serological, antigen, and ancillary tests used in hospitals. In this study, a biochip assay that can simultaneously detect SARS-CoV-2 protein and RNA from biofluids by using surface markers, and simultaneously detect/quantify target proteins and RNA at single virus resolution was developed. Amplification of the signals were achieved by targeting different regions of the viral RNA (e.g., viral nucleocapsid N1, N2), and a tyramide signal amplification (TSA) assay for viral surface proteins. To demonstrate the clinical utility of the technology, it was deployed and tested using different biofluids, including NPS, and saliva from COVID-19 patients.

Updated Date: 12/09/2022

Principal Investigator: Reategui, Eduardo

Has Data Files: No

Study Domain: Medical Device or Tool Development

Data Collection Method: Molecular Nucleic Acid or PCR Testing Device

Keywords: Biochip Assay; Biofluid Detection; Clinical Utility; Exosome; Exosome-based; RNA; S-protein

Study Design: Device Validation

Multi-Center Study: No

Data Types: Imaging

Study Start Date: 12/21/2020

Study End Date: 06/30/2023

Species: Human Data

Estimated Cohort Size: 100

Study Population Focus: Adults; Older Adults or Elderly

Publication URL: https://pubmed.ncbi.nlm.nih.gov/35579189/; https://pubmed.ncbi.nlm.nih.gov/36934525/

Acknowledgement Statement: This study was supported through funding, 4U18TR003807-02, for the National Center for Advancing Translational Sciences (NCATS) as part of the RADx-rad program. We acknowledge all the patients and healthy volunteers who participated in this study. Approved users should acknowledge the provision of data access by dbGaP for accession phs002709.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): 4U18TR003807-02

Consent/Data Use Limitations: General Research Use