I-Corps: Next-generation Microfluidics-based Drug Testing Platform

这个i-Corps项目的更广泛的影响/商业潜力是开发一种基于微流体的诊断设备，该设备可以在一个可以在实验室环境之外操作的紧凑平台上促进实验室质量分析。建议的技术特别适用于路边毒品检测、急救人员、急救医学、体育反兴奋剂、疼痛管理、康复中心、现场工作人员药物检测和其他应用。到2025年，全球药物滥用测试市场预计将达到118.3亿美元。用于医疗和娱乐用途的大麻合法化、阿片类药物危机以及新出现的危险特制毒品，都引起了人们对减少美国和国外滥用药物的经济影响和公共健康负担的技术的高度兴趣。最初的目标市场是执法药物测试，这是一个监管负担最小、迫切需要和高增长潜力的市场，并计划随着时间的推移扩展到劳动力和临床药物测试市场。这项技术在更广泛的医疗诊断市场也有实用价值，预计到2026年，全球市场规模将超过500亿美元。该I-Corps项目基于一种微流控设备的开发，该设备可促进微流控通道中流体的再循环。该方法是检测小体积流体中低丰度目标的关键。再循环是通过安装在一次性微流控装置中的泵实现的，该装置由读取器中的步进电机驱动。致动器的下压和退出产生了穿过生物传感器的脉动流。样品、试剂和洗涤缓冲液可以以最佳分析性能所需的所需速率和时间间隔再循环。建议的再循环流动方法被封装到一个完全集成的单芯片实验室设备中，能够处理少量的全血、口服液和其他生物基质。流体布局便于处理复杂的多步免疫分析序列。芯片实验室设备配备了高密度微阵列生物传感器，具有无与伦比的多路复用能力。此外，该平台还包括一个紧凑的、高度便携的电池供电阅读器，用于与墨盒一起工作。传感器响应的荧光图像由仪器内部的电荷耦合器件捕获。数据在仪器的屏幕上自动分析和报告给用户，并传输到移动应用程序。该奖项反映了NSF的法定使命，并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 I-Corps project is the development of a microfluidics-based diagnostic device that facilitates lab-quality analytics in a compact platform that may be operated outside of the laboratory environment. The proposed technology is especially ideal for roadside drug detection, first responders, emergency medicine, sports anti-doping, pain management, rehab centers, onsite workforce drug testing and other applications. The drug abuse testing market is projected to be $11.83B globally by 2025. The legalization of marijuana for medical and recreational use, the opioid crisis, and emerging dangerous designer drugs have generated high interest in technologies that reduce the economic impact and public health burden of drug abuse in the US and abroad. The initial target market is law enforcement drug testing, which has minimal regulatory burden, immediate need and high growth potential, with planned expansion into workforce and clinical drug testing market segments over time. This technology also has utility in the wider point-of-care diagnostics market, which is projected to be more than $50B globally by 2026. This I-Corps project is based on the development of a microfluidics device that facilitates the recirculation of fluid in a microfluidic channel. The proposed approach is key to detecting low abundance targets in small volumes of fluid. Recirculation is achieved by a pump incorporated into the disposable microfluidic device that is actuated by a stepper motor in the reader. Depression and withdrawal of the actuator creates a pulsatile flow across a biosensor. Sample, reagents, and wash buffers may be recirculated at the desired rate and time interval needed for optimal assay performance. The proposed recirculation flow method is packaged into a fully integrated lab-on-a-chip device capable of processing small volumes of whole blood, oral fluid, and other biological matrices. The fluidic layout facilitates processing complex multistep immunoassay sequences. The lab-on-a-chip device is outfitted with a high-density microarray biosensor for unparalleled multiplexing capability. In addition, the platform includes a compact, highly portable, battery-powered reader to work with the cartridge. Fluorescent images of the sensor response are captured by a CCD inside the instrument. Data is automatically analyzed and reported to the user on screen on the instrument and transmitted to a mobile App.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.