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

这项小型企业创新研究（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来缩短COVID-19的诊断时间。 所提出的技术有可能消除导致延迟诊断的样品处理瓶颈。 该系统外形紧凑，可广泛部署，可实现床旁和/或近床旁测试设置。 该系统包括读取器单元和一次性测试芯片。 这将有助于快速测试。这个小型企业创新研究（SBIR）第一阶段项目将推进全电子单分子分子诊断平台的原型，并演示SARS-CoV-2 RNA的直接检测。 原型完成将涉及将我们的单分子生物传感器集成到专用集成电路上，并优化化学功能化过程，以实现单分子检测。 将开发直接RNA检测所需的受控RNA片段化工艺。 直接检测将消除进行基于定量逆转录聚合酶链式反应（qRT-PCR）的系统中所需的大量酶处理的需要。 高效的数据处理算法将在数据采集硬件中设计和实现，以加速诊断。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 / 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.