AFS/SERS Saliva-based SARS-CoV-2 Earliest Infection and Antibodies Detection

项目概要/摘要： 这个U18应用程序是响应NIH的RADx-rad紧急响应COVID- 针对单个细胞外囊泡、外泌体和 细胞外RNA（exRNA）的分离和分析，并将它们重新定位用于检测SARS-CoV-2。的 申请人的团体是NIH共同基金“细胞外RNA通讯（ERC）”计划的受资助者 提出了一种新兴的声流分离技术（AFS），用于无标记，高产率和纯度 使用表面增强拉曼将来自生物流体的外来体与胞外RNA表征偶联 光谱（Sers）用于单个EV识别。U18的这一应用将重新定位AFS EV技术 和Sers用于感染患者唾液中SARS-CoV-2的非侵入性最早检测。宿主免疫力 SARS-CoV-2也将在唾液样本中进行评估，以便最早检测SARS-CoV-2 感染和宿主免疫性。 五个具体目标是在2年内重新定位基于唾液的AFS和Sers技术 U18提案，以检验综合多参数非侵入性唾液检测SARS-CoV的假设， 2感染、病毒载量和宿主免疫力测试证明临床性能超过当前基于唾液的 SARS-CoV-2 EUA检测。

Project Summary/Abstract: This U18 application is responsive to the NIH’s RADx-rad Emergency Responses to the COVID- pandemic for new or non-traditional technologies developed for single extracellular vesicle, exosome and extracellular RNA (exRNA) isolation and analysis and reposition them for detection of SARS-CoV-2. The applicant’s group is a grantee in the NIH Common Fund “Extracellular RNA Communication (ERC)” Program advancing a new and emerging technology of Acoustofluidic Separation (AFS) for label-free, high yield and purity exosomes from biofluids which is coupled to extracellular RNA characterization using Surface Enhanced Raman Spectroscopy (SERS) for single EV identification. This U18 application is to reposition the AFS EV technology and SERS for the non-invasive earliest detection of SARS-CoV-2 in saliva of infected patients. Host immunity to SARS-CoV-2 will also be assessed in the saliva samples, permitting the earliest detection of SARS-CoV-2 infection and host immunity non-invasively in a saliva sample. Five Specific Aims are in place to reposition the saliva-based AFS and SERS technologies, in a 2-year U18 proposal, to test the hypothesis that an integrated multi-parametric non-invasive saliva test for SARS-CoV- 2 infection, viral load and host immunity test demonstrating clinical performance surpassing current saliva-based SARS-CoV-2 EUA tests.