SBIR Phase II: COVID-19 Rapid Sensing Using Structural DNA Biosensors

该小型企业创新研究（SBIR）第一阶段项目的更广泛影响将是开发一种平台技术，用于创建快速病毒诊断，直接识别患者样本中的病毒表面蛋白模式，并在几分钟内生成准确的结果。目前的高保真病毒病原体诊断标准需要复杂的仪器、运行仪器的技术专业知识以及数小时的时间来产生和解释结果。所提出的平台创建了一种病毒特异性生物传感器，该生物传感器选择性地与目标病毒结合，并产生可见的结果，而无需耗时的预处理或昂贵的仪器。更低的检测成本和更快的样本到结果的周转可能会导致更有效地控制疾病的传播。该项目旨在开发一种用于检测冠状病毒的高功能、灵敏度和特异性诊断方法。该技术基于该公司的模式识别增强传感和治疗（PEST）概念。该解决方案是一流的诊断方法，它使用算法设计的结构DNA形成一个陷阱，可以检测并选择性地结合病原体的特征模式。这种识别和结合可以产生视觉信号，而不需要与当前一代分子测试（聚合酶链反应，PCR）相关的DNA/RNA预处理或扩增。该项目将涉及建立一个基于PEST的侧流COVID-19快速诊断的临床前原型，目标是在5分钟内为每个样本提供结果。 快速检测结果之后将进行临床前验证，以确定检测的特异性、检测限和实施机制，以提高检测特异性并避免与其他病毒类型的交叉反应。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。

The broader impact of this Small Business Innovation Research (SBIR) Phase I project will be the development of a platform technology for creating rapid virus diagnostics that directly recognizes the virus surface protein pattern from a patient sample and generates accurate results within minutes. Current standards for high-fidelity viral pathogen diagnostics require complex instruments, technical expertise to run the instruments, and hours to produce and interpret results. The proposed platform creates a virus-specific biosensor that selectively binds to the target virus and produces visible results without time-consuming pre-processing or expensive instruments. Lower cost tests and faster sample-to-result turnovers could result in more effective control of disease spread.This project seeks to develop a highly functional, sensitive, and specific diagnostic for the detection of coronavirus. This technology is based on the company’s Pattern-Recognition Enhanced Sensing and Therapeutics (PEST) concept. The solution is a first-in-class diagnostics that uses algorithmically-designed structural DNA to form a trap that may detect and selectively bind a signature pattern of the pathogen. This recognition and binding may generate visual signals without the need of DNA/RNA preprocessing or amplification associated with the current generation of molecular tests (polymerase chain reactions, PCRs). This project will involve building a preclinical prototype of PEST-enabled lateral flow based COVID-19 rapid diagnostics with a goal of providing results for each sample within 5 minutes. This fast test result will be followed by preclinical validation to determine the test’s specificity, limits of detection, and implement mechanism to improve the assay specificity and to avoid cross-reaction to other virus types.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.