Validation of Smart Masks for Surveillance of COVID-19

项目摘要。 脆弱人群不仅需要检测，还需要监测。理想的监视工具应该是 在被测试人群参与最少的情况下在后台运行；这将是简单的， 实惠、可靠、准确。不幸的是，目前还没有这样的监控系统。在这里，我们建议 一种“智能口罩”，当佩戴者接触到生物标志物(蛋白酶)时，它会改变颜色 新冠肺炎。已知唾液中存在这些蛋白水解酶，智能面膜将浓缩这些蛋白水解酶 当受试者通过智能口罩呼吸和说话时，会产生雾化唾液。这是一个简单的 然而，监视的新方法，因为大多数人已经戴着口罩-特别是在高- 风险设置。我们的第一个目标是优化将监测蛋白酶的试剂。我们将定制 只有当两个关键的SARS蛋白酶是 现在时。在对比色试剂进行表征后，Aim 2将把这些试剂整合成粘合剂 可贴在任何现有布料或外科口罩上的条带(即贴纸)。目标3是与人类进行验证 研究对象。首先，我们将使用生物库唾液样本，这些样本被确认为新冠肺炎阳性或 新冠肺炎阴性。接下来，我们将评估感染SARS-CoV-2的人必须呼吸多长时间 在智能口罩改变颜色之前通过它。最后，我们将使用智能口罩来监视 同时通过聚合酶链式反应进行定期检测的人群。我们将计算敏感度和 通过与聚合酶链式反应的比较，确定了智能口罩的特异性。我们将衡量真正的积极，真正的消极， 假阳性，假阴性，估计需要800个对象，这在我们的 机构。我们的团队非常适合进行这项研究，因为Jokerst博士接受过比色学方面的培训 Penny博士、Knight博士和Laurent博士拥有数十年的人体研究经验。 TU提供生物统计学经验来确认研究设计。这项工作可能会对 大流行是因为我们建议的设计结合了家庭验孕测试的简单性和 昂贵的基于病毒的检测的特异性。它是实用的，因为它使用了已经 在日常生活中很常见，通过简单的颜色变化报告SARS病毒的存在。而一种疫苗 将有望在这项工作的过程中部署，这里评估的蛋白酶已经 与多种SARS病毒有牵连。因此，如果未来出现大流行，这项工作将是有用的。

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.