RAPID: Nanomembranes for the Rapid Detection of SARS-CoV-2 in Biofluids

该RAPID项目准备开发一种快速廉价的检测方法，以检测导致全球COVID-19大流行的新型冠状病毒SARS-CoV-2的活动性感染。现有的快速检测战略成本高昂，限制了其在基于人口的筛查中的使用，特别是在最脆弱的低资源社区。相比之下，这里开发的测试将相对便宜，因为它既不需要外部电源，也不需要额外的样品制备和分析仪器。该测试将被调整，以检测在活动性感染个体中观察到的整个病毒载量范围。项目团队的目标是在项目的前三个月内设计原型设备并建立原理证明。为此，一个多元化和多学科的团队，包括六名研究生，一名博士后研究员，一名医生，两名本科生和两名美国-制造商将被动员起来。该项目将为学员提供深刻的人道主义和教育经验，因为他们快速但有意识地工作，以证明世界各地迫切需要的COVID-19测试设备的可行性。 该提案的总体目标是创建一种可制造的微流体设备，能够从鼻涕或痰中即时诊断活动性COVID-19感染。微流控装置将采用硅纳米膜来识别生物流体样品中SARS-CoV-2刺突蛋白的存在。不含SARS-CoV-2病毒或病毒颗粒小于SARS-CoV-2的样本不会登记阳性结果。将对研究者先前的流动池装置设计进行修改，以确保两个流动路径可以单独由所施加样品的表面张力驱动。调查人员与两名美国人签订了合同-为设备组件的高吞吐量制造提供技术支持。将用纳米颗粒SARS-CoV-2替代物和非SARS-CoV-2刺突蛋白对照进行概念验证。将进行研究以确定器械的灵敏度和特异性，最大限度地减少假阴性。将使用高通量策略进行器械制造，这些策略可以很容易地转化为大批量商业制造。一个成功的平台将在罗切斯特大学运营的纽约州流感中心用COVID-19患者的样本进行测试。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This RAPID project is poised to develop a fast and inexpensive test to detect active infections of the novel coronavirus, SARS-CoV-2, responsible for the global COVID-19 pandemic. The high costs of available rapid testing strategies limit their use in population-based screening, particularly in the most vulnerable low-resource communities. In contrast, the test developed here will be relatively inexpensive because it requires neither external power nor additional sample preparation and analysis instrumentation. The test will be tuned to detect the entire range of viral loads observed in individuals with active infections. The project team aims to both design the prototype device and establish proof-of-principle within the first three months of the project. To do so, a diverse and multidisciplinary team including six graduate students, a post-doctoral fellow, a medical doctor, two undergraduate students, and two U.S.-based manufacturers will be mobilized. The project will provide a profound humanitarian and educational experience for the trainees as they work quickly but deliberately to demonstrate the feasibility of a COVID-19 test device urgently needed throughout the world. The overall goal of the proposal is to create a manufacturable microfluidic device capable of instantaneous diagnosis of active COVID-19 infections from nasal mucus or phlegm. The microfluidic device will employ ultrathin silicon 'nanomembranes' to identify the presence of SARS-CoV-2 spike proteins in the biofluid sample. Samples without the SARS-CoV-2 virus or with viral particles smaller than SARS-CoV-2 will not register a positive result. Modifications to the investigators' prior flow cell device designs will be made to ensure the two flow paths can be driven by the surface tension of the applied sample alone. The investigators have contracted with two U.S.-based companies for high-throughput manufacturing of the device components. Proof-of-concept demonstration will be conducted with nanoparticle SARS-CoV-2 surrogates and non-SARS-CoV2 spike protein controls. Studies will be conducted to define the sensitivity and specificity of the device, minimizing false negatives. Device manufacturing will be done using high-throughput strategies that can be readily translated to high-volume commercial manufacturing. A successful platform will be tested with samples from COVID-19 patients at a New York State flu center run by the University of Rochester.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.