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

这项小企业创新研究（SBIR）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，其中大多数是由于芬太尼中毒。目前，筛查患者的毒性药物水平需要在医院实验室处理标本，需要数小时才能获得结果。在接触点、在救护车或急诊室中立即、准确地发现芬太尼中毒，将为快速诊断和改善中毒患者的护理创造新的范例，并挽救生命。SBIR二期项目的成果将是一种可以在几分钟内从血液或唾液中精确测量芬太尼和其他药物水平的手持传感器设备。该平台设备使用一次性传感器条，成本低，可扩展，允许广泛的商业应用。这种护理点测试技术未来的潜在应用包括由医生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。这个小型企业创新研究（SBIR）二期项目将测试一种创新的原型生物传感器设备，该设备使用类似于糖尿病血糖仪的廉价一次性测试条，为用户提供血液中有毒药物水平的实时、准确检测和定量。在二期项目中进行的研究将利用电分析方法优化传感器的性能，以提高其对芬太尼和其他常见中毒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相同的结果。该生物传感器将检测药物过量和其他药物低于治疗水平，不需要标本处理。试点大型动物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证明。该奖项反映了美国国家科学基金会的法定使命，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) 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.