dbGaP Study Accession: phs002583

NIH Institute/Center: NHLBI

RADx Data Program: RADx-rad

Release Date: 07/21/2022

DOI: 10.60773/vprs-gc97

Updated Date: 12/09/2022

Study Description: A novel testing platform that detects SARS-CoV-2 virions in a patient's breath was developed. When a person exhales into the COVID breathalyzer, droplets and other emitted particles are captured by a liquid impactor inside the collection unit. Subsequently, the captured particles were deposited onto a microfluidic chip that contains the nanowell sensors (patent pending) capable of detecting the presence of SARS-CoV-2 virus. The device provided results within a time frame of 20 minutes using an impedance measurement approach. Importantly, the novel platform technology in development could be easily adapted to future needs and challenges, not only as the virus causing COVID-19 evolves in future years, but also to provide multiplexing capabilities to detect multiple viruses in tandem. The target product profile (TPP) of this solution stood out against the current and future standard of care in viral antigen screening tests as a new disposable breathalyzer that is not invasive compared to traditional sampling techniques, is easy to use with rapid point of care results, and has accurate reporting with high sensitivity and specificity.

Principal Investigator: Panettieri, Reynold Alexander

Has Data Files: Yes

Study Domain: Medical Device/Tool Development; Virological Testing; Rapid Diagnostic Test (RDT)

Data Collection Method: Antigen Testing Device; Breath Analysis Device / Airborne Detection Device

Keywords: Spike Protein

Study Design: Device Verification Study

Multi-Center Study: FALSE

Data Types: Other; Immunological

Data Types, Other: Spike proteins via breath

Study Start Date: 12/21/2020

Study End Date: 11/30/2022

Species: Non-Human Data

Estimated Cohort Size: 500

Study Population Focus: Adults

Acknowledgement Statement: This study was supported through funding, 7U01HL150852-04, for the National Institute of Heart Lung and Blood Institute (NHLBI) as part of the RADx-rad program. A special acknowledgment to the research team for their hard work making this possible. Approved users should acknowledge the provision of data access by dbGaP for accession phs002583.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-19-014

NIH Grant or Contract Number(s): 7U01HL150852-04

Consent/Data Use Limitations: General Research Use