Validation of Smart Masks for Surveillance of COVID-19

项目摘要。 弱势群体不仅需要检测，还需要监测。理想的监视工具 在背景中操作，使待测试的人群参与最少;这将是简单的， 价格合理、可靠、准确。不幸的是，目前还没有这样的监测系统。在这里，我们建议 一种“智能口罩”，当佩戴者暴露于生物标志物（蛋白酶）时，它会改变颜色， 2019冠状病毒病。已知这些蛋白酶存在于唾液中，智能面膜会将这些蛋白酶集中起来 当受试者通过智能面罩呼吸和说话时，这是一个简单 然而，由于大多数人已经戴上了面具，特别是在高中， 风险设置。我们的第一个目标是优化监测蛋白酶的试剂。我们将定制 所述肽序列使得所述试剂仅在两种关键SARS蛋白酶被 礼物在对比色试剂进行表征后，Aim 2将这些试剂整合到粘合剂中 剥离（即，粘贴物），其可以粘贴到任何现有的布或外科口罩上。目标3是通过人体验证 科目首先，我们将使用生物库中的唾液样本，这些样本被确认为COVID-19阳性， 新型冠状病毒阴性。接下来，我们将评估SARS-CoV-2感染者必须呼吸多长时间 在它改变颜色之前通过智能面罩。最后，我们将使用智能面具监视一个 同时通过PCR定期检测的人群。我们将计算灵敏度， 通过与PCR进行比较，确定智能口罩的特异性。我们将衡量真阳性，真阴性， 假阳性和假阴性，估计需要800名受试者，这在我们的研究中是非常可行的。 机构。我们的团队非常适合进行这项研究，因为Jokerst博士的训练比色法 彭尼博士、奈特博士和劳伦特博士都有几十年的人类研究经验。 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 因为我们提出的设计结合了家庭怀孕测试的简单性和 昂贵的基于病毒的测定的特异性。它是实用的，因为它使用的面具， 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。虽然疫苗 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病毒有关。因此，如果未来出现大流行病，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.