STTR Phase I: Advanced Microfluidic Devices for Point-of-Care COVID-19 Serological Testing

此小企业技术转让（STTR）第一阶段项目的更广泛影响/商业潜力可能惠及数百万人，并为在COVID-19大流行期间保障公众健康提供关键工具。敏感、选择性和定量检测通常需要复杂的实验室方法和仪器来实现一致的结果;然而，该项目推进了简化过程的技术。抗体检测可提供有关既往感染的信息;检测低浓度存在的简单工具可更好地进行检测，以管理社交距离需求。该技术旨在使SARS-Cov-2的血液检测简单，并对两种类型的抗体进行定量。该设备将被开发为直接采集患者样本，无需复杂的样本准备。将创建独特的试剂，用于选择性检测SARS-CoV-2抗体。该小型企业技术转让（STTR）第一阶段项目旨在开发下一代低成本护理点免疫测定技术，直接应用于传染病检测。 本文提出的技术结合了一种新的方法来控制毛细管流动驱动系统，该系统应用于一次性装置中的传统ELISA的步骤。该项目开发的设备将检测患者样本中的SARSCoV-2特异性抗体，并能够提供有关患者免疫反应阶段的信息。此外，将ELISA样酶扩增适应于床旁装置将提供比传统侧流测定更高的灵敏度和选择性，增加测定灵敏度并改善早期感染的检测。免疫分析将与去识别的患者样本进行评估，并与最先进的基于实验室的检测方法进行比较。该奖项反映了NSF的法定使命，并被认为值得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。

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project may reach millions of people and provide a key tool in safeguarding the public health through the COVID-19 pandemic. Sensitive, selective and quantitative detection usually requires complex laboratory-based methods and instrumentation to achieve consistent results; however, this project advances technologies to simplify the process. Antibody testing provides information regarding previous infections; a simple tool to detect presence at low concentrations enables better testing to manage social distancing needs. The proposed technology aims to make blood testing for SARS-Cov-2 simple and quantitative for two types of antibodies. The device will be developed to take patient samples directly with no complicated sample prep. Unique reagents will be created for selective detection of the SARS-CoV-2 antibodies. This Small Business Technology Transfer (STTR) Phase I project aims to develop the next generation of low-cost point of care immunoassay technology with direct application to infectious disease detection. The technology proposed here combines a new approach to controlling capillary flow driven systems applied to the steps of a traditional ELISA in a disposable device. The device developed in this project will detect SARSCoV-2 specific antibodies in patient samples, and will be able to provide information about the phase of the immune response of a patient. Additionally, adaption of ELISA-like enzymatic amplification into a point-of-care device will provide greater sensitivity and selectivity than traditional lateral flow assays, increasing assay sensitivity and improving detection of early infections. The immunoassays will be evaluated with deidentified patient samples and compared to state of the art laboratory-based detection methods.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.