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

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，处方药中毒每年影响100多万人，是美国与伤害相关的死亡的主要原因。除阿片类药物外，处方中的苯二氮卓类药物、抗精神病药物和抗抑郁药物是导致意外中毒和自杀未遂的最常见原因。药物检测在检测和管理中毒患者方面发挥着核心作用，能够迅速确定原因并及时进行有针对性的治疗，有可能减少发病率和挽救生命。目前，血液和其他生物体液中有毒药物水平的筛查需要样本处理，需要几个小时或几天的时间才能从商业实验室获得结果。在救护车或急诊室对紧急护理进行及时、准确、低成本的检测将改善意外中毒和自杀未遂患者的快速诊断和护理结果。该项目中描述的生物传感器设备和药物测试方法可以在第一次接触时以低成本进行，并且可以扩展到全球药物筛选市场的快速商业和临床应用，价值11亿美元。这个小型企业创新研究(SBIR)第一阶段项目将测试一种新的固态生物传感器设备，使用类似于糖尿病血糖仪的廉价一次性测试试纸或从唾液(如舌下电子温度计)报告实时和准确的有毒药物水平。目前的药物毒性分析使用专门的实验室方法，需要对血液样本进行处理，可能需要几个小时到几天的时间才能获得结果。生物传感器是生物学和电子学之间的接口，可以将特定的化学信息转换为可测量的电子信号(例如血糖仪)。该项目的三个具体成果将是；1)一种手持医疗设备，提供从一滴血或唾液中准确和实时地测量临床上使用的所有类别的抗精神病药物、抗精神病药物和抗惊厥药物以及其他常见滥用药物的血液浓度，2)相对于当前的实验室分析方法(例如，质谱学)验证针对目标药物的生物传感器的准确性，以及3)证明该生物传感器可以区分药物类别、滥用药物该奖项反映了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 Small Business Innovation Research (SBIR) Phase I project is that poisoning by prescription drugs affects over one million people annually and is the leading cause of injury-related death in the United States. Other than opioids, prescribed benzodiazepines, antipsychotics, and antidepressants are the most common causes of accidental poisoning and attempted suicide. Drug testing plays a central role in the detection and management of poisoned patients, and the ability to rapidly identify the cause and institute prompt targeted treatment has the potential to reduce morbidity and save lives. Currently, screening of blood and other biological fluids for toxic drug levels requires specimen processing, taking hours or days to obtain results from commercial laboratories. Immediate, accurate, low-cost testing for urgent care in the ambulance or emergency room will improve outcomes for the rapid diagnosis and care of patients after accidental poisoning and attempted suicide. The biosensor device and drug testing methods described in this project can be performed for low cost at the first point of contact and are scalable for rapid commercial and clinical adoption into a global drug screening market valued at $1.1 billion.This Small Business Innovation Research (SBIR) Phase I project will test a new solid-state biosensor device reporting real-time and accurate quantification of toxic drug levels in the blood using inexpensive, disposable test strips similar to a diabetes glucometer or from saliva like a sublingual electronic thermometer. Current drug toxicity assays use specialized laboratory methods that require blood sample processing and can take hours to days to obtain results. Biosensors are an interface between biology and electronics that convert specific chemical information into measurable electronic signals (e.g. a glucometer). The three specific outcomes of this project will be; 1) a handheld medical device providing accurate and real-time measurement of blood levels of all classes of antipsychotic, neuroleptic, and anticonvulsant drugs in clinical use, and other common drugs of abuse, from a drop of blood or saliva, 2) validation of the accuracy of the biosensor for target drugs relative to current laboratory analysis methods (e.g., mass spectroscopy), and 3) demonstration that the biosensor can distinguish between classes of medications, drugs of abuse, and potential clinical interferents in blood using specific analytical methods and modifiable biosensor coatings.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.