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Validation of Smart Masks for Surveillance of COVID-19

用于监测 COVID-19 的智能口罩的验证

基本信息

批准号：
10273452
负责人：
Jesse Vincent Jokerst
金额：
$ 34.86万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN DIEGO
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-12-21 至 2022-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10273452
关键词：
3-Dimensional Adhesives Biological Assay Biological Markers Biometry Bulla COVID-19 COVID-19 diagnosis COVID-19 early detection COVID-19 surveillance COVID-19 susceptibility Caregivers Clinic Color Communities Complex Custom Data Coordinating Center Dialysis procedure Exposure to Future Goals Gold Health care facility Home Hospitals Human Human Resources Human Subject Research Individual Infrastructure Institution Laboratories Life Literature Masks Measures Methods Monitor N95 mask Outcome Papain Patient Care Patients Peptide Hydrolases Peptides Persons Population Predictive Value Pregnancy Tests Preparation Prisons RADx Radical Reagent Recombinants Reporter Reporting Research Research Design Respirators Risk SARS coronavirus SARS-CoV-2 exposure SARS-CoV-2 infection SARS-CoV-2 negative SARS-CoV-2 positive Saliva Sampling Sensitivity and Specificity Serology Severe Acute Respiratory Syndrome Skilled Nursing Facilities Specificity System Testing Time Training Vaccines Validation Viral Viral Load result Viral Physiology Virus Vulnerable Populations Work aerosolized base biobank coronavirus disease data sharing design detection limit experience high risk human subject infection risk innovation nanoGold novel strategies pandemic disease particle patient home care point of care protein aminoacid sequence saliva sample surgical mask test strip tool

项目摘要

Project Summary. 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 surveillance system yet exists. Here, we propose a “smart mask” that changes colors when the wearer has been exposed to biomarkers (proteases) of COVID-19. These proteases are known to be in saliva, and the smart mask will concentrate the proteases from aerosolized saliva when the subject breathes and speaks through the smart mask. This is a simple yet novel approach to surveillance because most people are already wearing masks—especially in high- risk settings. Our first goal is to optimize the reagents that will monitor the proteases. We will customize the peptide sequences such that the reagents change color only when two key SARS proteases are present. After characterizing the colorimetric reagents, Aim 2 will integrate these reagents into an adhesive strip (i.e., a sticker) that can be affixed to any existing cloth or surgical mask. Aim 3 is validation with human subjects. First, we will use biobanked saliva samples that are confirmed to be either COVID-19-positive or COVID-19-negative. Next, we will evaluate how long people infected with SARS-CoV-2 must breathe through the smart mask before it changes colors. Finally, we will use the smart mask for surveillance of a population that is concurrently being tested regularly via PCR. We will calculate the sensitivity and specificity of the smart masks through comparison to PCR. We will measure true positives, true negatives, false positives, and false negatives and estimate needing 800 subjects, which is very feasible at our institution. Our team is well-suited to conduct this research because of Dr. Jokerst’s training colorimetric sensing; Drs. Penny, Knight, and Laurent have decades of human subjects research experience, and Dr. Tu offers biostatistical experience to confirm study design. This work could have a significant impact on the pandemic because our proposed design combines the simplicity of the home pregnancy test with the specificity of expensive viral-based assays. It is practical because it uses the masks that are already common in daily life and reports the presence of SARS viruses via a simple color change. While a vaccine will hopefully be deployed during the course of this work, the proteases evaluated here have been implicated in a variety of SARS viruses. Thus, this work will be useful should future pandemics emerge.

项目总结。