SBIR Phase II: Point-of-Care Electrochemical Platform for the Rapid Detection of Drug Toxicity

这一小企业创新研究第二阶段项目的更广泛影响/商业潜力是，滥用药物中毒每年影响近300万人，是美国与伤害有关的死亡的主要原因。2021年，美国有100，306例阿片类药物过量死亡，其中大部分是由于芬太尼中毒。筛查患者的毒性药物水平目前需要在医院实验室进行标本处理，需要数小时才能获得结果。在救护车或急诊室的接触点立即准确地检测芬太尼中毒，将为快速诊断和改善中毒患者的护理并挽救生命创造一个新的范例。SBIR第二阶段项目成果将是一种FDA准备好的手持式传感器设备，能够在几分钟内从一滴血液或唾液中准确测量芬太尼和其他药物水平。该平台装置使用一次性传感器条，并且成本低且可扩展，允许广泛的商业应用。这种床旁检测技术的未来潜在应用包括医生将其用于基于办公室的治疗药物监测筛查，以确认依从性并优化药物使用和疗效。这项小型企业创新研究（SBIR）第二阶段项目将测试一种创新的原型生物传感器设备，该设备为用户提供真实的时间，准确检测和定量血液中的有毒药物水平，使用廉价的一次性试纸，类似于糖尿病血糖仪。在第二阶段项目中进行的研究将利用电分析方法来优化传感器的性能，以提高其对芬太尼和其他通常与中毒有关的药物的选择性和最低检测限。其他方法、传感器涂层和测试条件将用于检测血液中的总药物水平，并证明生物传感器可以区分药物类别和潜在的临床干扰物，并显示与当前临床实验室方法等效的结果。生物传感器将检测过量的药物和低于治疗水平的其他药物，而无需样品处理。大型动物试验研究将寻求验证血液中药物水平与唾液的相关性，以建立快速舌下药物毒性测试的概念验证。该奖项反映了NSF的法定使命，并被认为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来支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is that poisoning by drugs of abuse affects almost 3 million people annually and is the leading cause of injury-related death in the United States. There were 100,306 opioid overdose deaths in the US in 2021, the majority of which were due to fentanyl poisoning. Screening patients for toxic drug levels currently requires specimen processing in hospital laboratories, taking hours to obtain results. Immediate, accurate detection of fentanyl poisoning at the point of contact, in the ambulance or emergency room, will create a new paradigm for the rapid diagnosis and improved care of poisoned patients and save lives. The SBIR Phase II project outcome will be an FDA-ready, hand-held sensor device capable of accurately measuring fentanyl and other drug levels from a drop of blood or saliva within minutes. The platform device uses disposable sensor strips and is low cost and scalable, permitting broad commercial adoption. Future potential applications for this point of care testing technology include its use by physicians for office-based screening for therapeutic drug monitoring to confirm compliance and optimize medication use and efficacy. This Small Business Innovation Research (SBIR) Phase II project will test an innovative, prototype biosensor device that provides the user with real time, accurate detection and quantification of toxic drug levels in the blood using inexpensive, disposable test strips similar to a diabetes glucometer. The research to be performed in the Phase II project will utilize electroanalytical methods to optimize the performance of the sensor to improve its selectivity and lowest limit of detection for fentanyl and other drugs commonly associated with poisoning. Additional methods, sensor coatings, and testing conditions will be used to detect total-drug levels in the blood and demonstrate that the biosensor can distinguish between classes of medications and potential clinical interferents as well as show equivalent results to current clinical laboratory methods. The biosensor will detect drugs of overdose and other medications below therapeutic levels, without specimen processing. Pilot large animal studies will seek to validate the correlation of drug levels in the blood with saliva to establish a proof of concept for rapid sublingual testing for drug toxicity.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.