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Validation of Smart Masks for Surveillance of COVID-19

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DataCite Commons2024-05-15 更新2024-07-13 收录
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https://radxdatahub.nih.gov/study/49
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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 yet exists. Here, we propose a “smart mask” that changes colors when the wearer has been exposed to biomarkers (proteases) of COVID-19. This is a 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 test 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 test strip 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.
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NIH Rapid Acceleration of Diagnostics Data Hub (RADx Data Hub)
创建时间:
2024-05-15
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