SBIR Phase I: COVID-19 Detection on a Handheld Smartphone-Enabled Platform

这个小型企业创新研究项目的更广泛的影响/商业潜力是一个手持智能手机驱动的硬件平台，用于快速检测鼻拭子样本中的新冠肺炎。拟议的项目将转换一个便携式智能手机支持的平台，在标准临床环境或更低资源的设施中，在30-90分钟内检测到患者样本中的新冠肺炎。诊断后，数据立即被记录下来，并通过地理映射和时间戳进行加密，以供公共卫生使用。这种新颖而主动的检测方法可以使社区快速检测到新冠肺炎并监测疫情数据，以抑制疾病传播。此小企业创新研究第一阶段项目旨在解决开发快速且便携的新冠肺炎看护点诊断系统的需求。第一阶段项目的范围是开发一种强大的核酸分析方法，以特异和灵敏地检测手持智能手机设备中的新冠肺炎。本项目提出了一种优化的核酸扩增试验，该方法具有高选择性和快速的特点，同时保持了敏感性、特异性和低的假阳性率。此外，该项目将在鼻咽(鼻)拭子和病毒传输介质存在的情况下测试优化的分析，为新鲜和存储样本的临床分析准备一个强大的平台。该项目将把这种分析集成到一个用于快速新冠肺炎核酸诊断的样本对答案设备中。这一奖项反映了美国国家科学基金会的法定使命，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) project is a handheld smartphone-enabled hardware platform for the rapid detection of COVID-19 in nasal swab samples. The proposed project will translate a portable smartphone enabled platform to detect COVID-19 in patient samples in 30-90 minutes in a standard clinical setting or in an even lower-resource facility. After diagnosis, data are immediately recorded and encrypted with geo-mapped and time-stamped for public health use. This novel and proactive approach for detection can enable communities to rapidly detect COVID-19 and monitor outbreak data to suppress disease spread. This Small Business Innovation Research (SBIR) Phase I project addresses the need to develop a rapid and portable COVID-19 point-of-care diagnostic. The scope of the Phase I project is to develop a robust nucleic acid assay to specifically and sensitively detect for COVID-19 in a handheld smartphone-enabled device. This project proposes an optimized nucleic acid amplification assay that is highly selective and rapid, while maintaining sensitivity, specificity, and a low false positive rate. Additionally, the project will test the optimized assay in the presence of nasopharyngeal (nasal) swabs and viral transport media, preparing a robust platform for clinical analysis of both fresh and stored samples. The project will integrate the assay into a sample-to-answer device for fast COVID-19 nucleic acid 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.