SBIR Phase I: Rapid COVID-19 diagnostics with CMOS-integrated single-molecule field-effect transistors

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是，通过开发新型全电子单分子分子诊断平台，缩短COVID-19的诊断时间。所提出的技术有可能消除导致诊断延迟的样品处理瓶颈。该系统结构紧凑，可广泛部署，可实现护理点和/或近护理点测试设置。该系统包括一个读取器单元和一次性测试芯片。这将使快速测试成为可能。这个小企业创新研究（SBIR）一期项目将推进全电子单分子分子诊断平台的原型，并演示直接检测SARS-CoV-2 RNA。原型完成将包括将我们的单分子生物传感器集成到特定应用的集成电路中，并优化化学功能化过程，以实现单分子检测。过程将被开发用于控制RNA碎片，需要直接RNA检测。直接检测将消除在定量反转录聚合酶链反应（qRT-PCR）系统中需要进行广泛的酶处理的需要。在数据采集硬件中设计和实现高效的数据处理算法，以加快诊断速度。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 is to reduce time-to-diagnosis for COVID-19 through the development of a novel all-electronic single-molecule molecular diagnostics platform. The proposed technology has the potential to eliminate sample processing bottlenecks that have resulted in delayed diagnosis. The system's form-factor is compact and widely deployable, enabling point-of-care and/or near-point-of-care test settings. The system comprise a reader unit and disposable test-chips. This will enable rapid testing. This Small Business Innovation Research (SBIR) Phase I project will advance a prototype of a all-electronic single-molecule molecular diagnostics platform and demonstrate direct detection of SARS-CoV-2 RNA. Prototype completion will involve integrating our single-molecule biosensors onto application-specific integrated circuitry and optimizing the chemical functionalization process to enable single-molecule detection. Processes will be developed for controlled RNA fragmentation, required for direct RNA detection. Direct detection will eliminate the need to perform extensive enzymatic processing required in quantitative Reverse-Transcription Polymerase-Chain-Reaction (qRT-PCR)-based systems. Efficient data processing algorithms will be designed and implemented in the data acquisition hardware to accelerate diagnosis.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.