NIH RADx Data Hub - Study Overview

Study Information

dbGaP Study Accession: phs002524

NIH Institute/Center: NIDCR

RADx Data Program: RADx-rad

DOI: 10.60773/7gn8-9w03

Release Date: 07/20/2022

Study Description: Vulnerable populations do not just need testing; they need surveillance. The ideal surveillance tool would operate in the background with minimal involvement of the population to be tested; it would be simple, affordable, reliable, and accurate. Unfortunately, no such assay existed. This project examined a smart mask that changes colors when the wearer has been exposed to biomarkers (proteases) of COVID-19 -- a novel approach to surveillance because most people are already wearing masks, especially in high-risk settings. The first goal was to optimize the reagents that will test the proteases. The peptide sequences were customized such that the reagents change color only when two key SARS proteases were present. After characterizing the colorimetric reagents, Aim 2 integrated these reagents into an adhesive test strip that can be affixed to any existing cloth or surgical mask. Aim 3 involved validation with human subjects. First, biobanked saliva samples that were confirmed to be either COVID-19-positive or COVID-19-negative were used. Next, how long people infected with SARS-CoV-2 must breathe through the smart mask before it changed color was evaluated. Finally, the smart mask was used for surveillance of a population that was concurrently being tested regularly via PCR. The sensitivity and specificity of the smart masks were calculated through comparison to PCR. True positives, true negatives, false positives, and false negatives were measured and 800 subjects were recruited at the University of California, San Diego.

Updated Date: 10/30/2023

Principal Investigator: Jokerst, Jesse Vincent

Has Data Files: Yes

Study Domain: Disease Surveillance; Medical Device or Tool Development; Multimodal Surveillance; Virological Testing

Data Collection Method: Wearable

Keywords: Biological Markers; Colorimetric Sensing; Individual-Level Data; Innovation; Masks; Novel Strategies; Predictive Value; Sensitivity and Specificity; Surveillance Data; Wearable Device Data

Study Design: Longitudinal Cohort

Multi-Center Study: No

Data Types: Clinical; Imaging

Study Start Date: 12/21/2020

Study End Date: 11/30/2023

Species: Human Data

Estimated Cohort Size: 800

Study Population Focus: Adults; Underserved or Vulnerable Populations

Acknowledgement Statement: This study was supported through funding, 5R01DE031114-03, for the National Institute of Dental and Craniofacial Research (NIDCR) as part of the RADx-rad program. We also thank all study participants for their time. Approved users should acknowledge the provision of data access by dbGaP for accession phs002524.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-20-016

NIH Grant or Contract Number(s): 5R01DE031114-03

Consent/Data Use Limitations: General Research Use

Study Documents

Study Documents Table
Document	Document Name	File Size	Download
Study Documentation	phs002524_Protocol.pdf	253.29 KB

Data Files

This study currently has no data files. Please check back at a later date.