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

这个小型企业创新研究（SBIR）项目的更广泛影响/商业潜力是一个支持手持智能手机的硬件平台，用于快速检测鼻拭子样本中的COVID-19。拟议的项目将转换一个便携式智能手机支持的平台，在标准临床环境或资源更低的设施中，在30-90分钟内检测患者样本中的COVID-19。诊断后，数据立即被记录和加密，并带有地理地图和时间戳，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COVID-19并监测疫情数据，以抑制疾病传播。这个小型企业创新研究（SBIR）第一阶段项目解决了开发快速便携式COVID-19护理点诊断的需求。第一阶段项目的范围是开发一种强大的核酸检测方法，以特异性和灵敏度检测手持智能手机设备中的COVID-19。该项目提出了一种优化的核酸扩增检测方法，该方法具有高度选择性和快速性，同时保持灵敏度，特异性和低假阳性率。此外，该项目将在存在鼻咽（鼻）拭子和病毒转运培养基的情况下测试优化的检测试剂盒，为新鲜和储存样本的临床分析准备稳健的平台。该项目将把该检测方法集成到一个样本到答案的设备中，用于快速诊断COVID-19核酸。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) 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.