dbGaP Study Accession: phs002602
NIH Institute/Center: NHLBI
RADx Data Program: RADx-rad
DOI: 10.60773/dnv2-mx89
Release Date: 09/04/2024
Updated Date: 11/15/2021
Study Description: To help diversify the approaches that can be used to sensitively detect SARS-CoV-2 and improve response resilience, an established virus detection system that has already shown the ability to detect viruses such as Ebola and Marburg viruses were pivoted and a focused assay for SARS-CoV-2 was developed. In parallel, rapidly scalable sensor chips and an automated reader was prototyped to enable deployment of rapid and sensitive POC viral diagnostics assays based on a simple interferometric reflectance imaging sensor (IRIS) platform. The multiplexed and configurable assays using robust universal DNA functionalized sensor chips, proposed diagnostic was performed in the presence of influenza. A patient with flu-like symptoms could be diagnosed with flu or COVID-19, or both as feared that these infections can occur concurrently. The study also prototyped a high-throughput system that tests samples directly in microwell plates to run 2,000 tests/day per instrument.
Principal Investigator: Unlu, Selim
Has Data Files: No
Study Domain: Medical Device/Tool Development; Virological Testing; Point-of-Care (POC) Testing
Data Collection Method: Unspecified COVID Testing Device
Keywords: Assay Development; Near Patient Testing
Study Design: Device Verification Study
Multi-Center Study: FALSE
Data Types: Immunological; Other
Data Types, Other: Discarded deidentified clinical samples (nasopharyngeal (NP) and anterior nares (AN) swabs)
Study Start Date: 12/21/2020
Study End Date: 08/31/2022
Species: Human Data
Estimated Cohort Size: 50
Study Population Focus: Adults
Acknowledgement Statement: This study was supported through funding, 4U54HL119145-08, for the National Heart Lung and Blood Institute (NHLBI) as part of the RADx-rad program. Approved users should acknowledge the provision of data access by dbGaP for accession phs002602.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-HL-13-008
NIH Grant or Contract Number(s): 4U54HL119145-08
Consent/Data Use Limitations: General Research Use