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

这个小企业创新研究(SBIR)第二阶段项目的更广泛的影响/商业潜力是，滥用药物中毒每年影响近300万人，是美国与伤害相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。目前，对患者进行有毒药物水平筛查需要在医院实验室进行样本处理，需要数小时才能获得结果。在接触点、救护车或急诊室立即、准确地检测到芬太尼中毒，将为快速诊断和改善对中毒患者的护理并拯救生命创造一个新的范例。SBIR第二阶段项目的成果将是一种FDA就绪的手持传感器设备，能够在几分钟内准确测量一滴血液或唾液中的芬太尼和其他药物浓度。该平台设备使用一次性传感器条，成本低，可扩展，允许广泛的商业采用。这一护理点测试技术未来的潜在应用包括医生使用它进行基于办公室的筛查，以进行治疗药物监测，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)第二阶段项目将测试一种创新的原型生物传感器设备，为用户提供实时、准确的血液中有毒药物水平的检测和量化，使用类似于糖尿病血糖仪的廉价一次性试纸。将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常见中毒药物的选择性和最低检测下限。还将使用其他方法、传感器涂层和测试条件来检测血液中的总药物浓度，并证明该生物传感器可以区分药物类别和潜在的临床干扰物质，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过量药物和治疗水平以下的其他药物，而不需要进行样本处理。大型动物试验性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。这一奖项反映了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 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.