SBIR Phase I: COVID-19 Rapid Sensing Using Structural DNA Biosensor

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将是开发一种新的COVID-19病毒快速诊断系统，该系统可以识别特定的病毒表面特征，并在几分钟内产生准确的结果。目前的病毒诊断标准涉及复杂的仪器和技术专业知识，需要数小时才能产生和解释结果。拟议的技术是一种传感器，可以选择性地与COVID-19病毒相互作用，从而产生可见的结果，而无需昂贵的仪器或耗时的程序。这项基础技术还可以用于快速、廉价地开发新的诊断测试。较低的检测成本和更快的从样本到结果的时间将大大改善疾病的测量和控制，支持公共卫生需求。本项目提出基于模式识别增强传感和治疗（PEST）概念开发一种高功能、敏感和特异性的冠状病毒诊断方法。提出的诊断解决方案使用算法设计的结构DNA来形成一个陷阱，该陷阱将检测病原体的“特征模式”，并选择性地与病原体结合以产生信号，而不需要与当前实践状态相关的DNA/RNA预处理或扩增。拟议的工作是建立一个基于pest的基于横向流的COVID-19快速诊断的临床前原型；技术性能目标是从样本到结果的时间为5分钟。这项工作还将进行临床前验证，以验证其特异性和检测限，并实施机制来提高检测特异性，以避免与冠状病毒家族中的其他病毒类型发生交叉反应。该奖项反映了美国国家科学基金会的法定使命，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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will be the development of a new rapid COVID-19 virus diagnostic system that recognizes specific virus surface characteristics and generates accurate results within minutes. The current viral diagnostics standard involves complex instruments and technical expertise to run, taking hours to produce and interpret a result. The proposed technology is a sensor that selectively interacts with the COVID-19 virus to produce visible results without expensive instruments or time-consuming procedures. The fundamental technology can also be adapted to rapidly and cheaply develop new diagnostic tests. The lower cost of the test and faster sample-to-result time will greatly improve disease measurement and control, supporting public health needs. This project proposes to develop a highly functional, sensitive and specific diagnostic for the diagnosis of coronavirus based on a Pattern-Recognition Enhanced Sensing and Therapeutics (PEST) concept. The proposed diagnostic solution uses algorithmically designed structural DNA to form a trap that will detect the “signature pattern” of the pathogen and selectively bind to it to generate a signal, without the need of DNA/RNA preprocessing or amplification associated with the current state of practice. The proposed work is to build a pre-clinical prototype of PEST-enabled lateral flow-based COVID-19 rapid diagnostics; the technical performance goal is a sample-to-result time of 5 minutes. The proposed work will also perform pre-clinical validation to validate its specificity and detection limit, as well as implement mechanisms to improve the assay specificity to avoid cross-reaction to other virus types in the Coronavirus family.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.