SBIR Phase I: Development and assessment of a diagnostic platform for rapid identification of COVID-19 patients without using custom reagents

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是部署一种诊断方法，以快速和廉价地检测COVID-19感染。除了识别COVID-19患者的短期目标外，该技术还将为全国范围内的实时感染跟踪提供强有力的支持。诊断的相同硬件组件可用于识别各种各样的病原体，而无需定制试剂。该系统将与基于云的数据库和监测系统一起工作，以快速识别病原体活动增加的热点，从而能够更快地对新病原体做出反应，因为不需要与硬件相关的开发，制造和分销。一旦获得新病原体的指纹，它可以很容易地分发到部署的仪器，使新的病原体的立即跟踪。这项小型企业创新研究（SBIR）第一阶段项目旨在开发一种快速诊断方法，能够直接从样本基质中检测SARS-nCoV 2，而无需使用定制试剂（如DNA）或冷供应链。该方法在一次性检测盒和注射泵的帮助下直接从标本中分离出完整的病毒。然后使用傅里叶变换红外光谱法（FTIR）鉴定分离的病毒。拟议的工作利用了病毒和样品基质组分之间对机械应力的差异反应。这种差异反应用于选择性地仅裂解样品基质组分，而不是病毒。随后通过基于大小的分离方法（如过滤）将碎片与病毒分离，从而能够直接从样品中快速分离各种病原体。FTIR用于鉴定分离的病毒，因为病原体在红外区域显示出独特的光谱指纹。拟议的第一阶段工作将制定分离和鉴定完整病毒的方案，并将证明鼻咽拭子样本的性能。该奖项反映了NSF的法定使命，并被认为是值得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的支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to deploy a diagnostic to rapidly and inexpensively detect COVID-19 infections. Beyond the short-term goal of identifying COVID-19 patients, the technology will lend strong support for real-time infection tracking nationally. The same hardware components of the diagnostic can be used to identify a wide variety of pathogens without custom reagents. The system will work with a cloud-based database and monitoring system to rapidly identify hotspots of increased pathogen activity, enabling faster response to new pathogens since no hardware-related development, manufacturing, and distribution are needed. Once a new pathogen’s fingerprint is obtained, it can be easily distributed to deployed instruments to enable immediately tracking of the new pathogen. This Small Business Innovation Research (SBIR) Phase I project aims to develop a rapid diagnostic capable of detecting SARS-nCoV2 directly from sample matrices without the use of custom reagents (like DNA) or a cold supply chain. The approach isolates intact virus directly from the specimen with the help of a disposable cartridge and a syringe pump. The isolated virus is then identified using Fourier-Transform Infrared Spectrometry (FTIR). The proposed work leverages the differential response to mechanical stress between the virus and the components of a sample matrix. This differential response is used to selectively lyse only the sample matrix components, not the virus. The debris is subsequently separated from the virus by size-based separation methods such as filtration, enabling rapid isolation of a broad range of pathogens directly from the sample. FTIR is used to identify the isolated virus since pathogens exhibit unique spectral fingerprints in the infrared region. The proposed Phase I effort will develop the protocol for isolating and identifying intact virus and will demonstrate the performance with nasopharyngeal swab samples. The results will be compared against results from RT-PCR methods to assess comparability.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.