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

这个小企业创新研究第一阶段项目的更广泛的影响/商业潜力是通过开发一个新型的全电子单分子分子诊断平台来减少新冠肺炎的诊断时间。这项拟议的技术有可能消除导致诊断延迟的样本处理瓶颈。该系统外形紧凑，可广泛部署，支持护理点和/或接近护理点的测试设置。该系统包括阅读器单元和一次性测试芯片。这将使快速测试成为可能。这个小型企业创新研究(SBIR)第一阶段项目将推进一个全电子单分子分子诊断平台的原型，并演示对SARS-CoV-2RNA的直接检测。原型的完成将涉及将我们的单分子生物传感器集成到特定用途的集成电路上，并优化化学功能化过程以实现单分子检测。将开发直接检测RNA所需的受控RNA片段化的过程。直接检测将不再需要在基于定量逆转录聚合酶链式反应(qRT-PCR)的系统中进行广泛的酶处理。将在数据采集硬件中设计和实施高效的数据处理算法，以加快诊断速度。该奖项反映了NSF的法定使命，并已通过使用基金会的智力优势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.