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

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是，处方药中毒每年影响超过100万人，是美国与伤害有关的死亡的主要原因。除了阿片类药物，处方苯二氮卓类药物，抗精神病药和抗抑郁药是意外中毒和自杀未遂的最常见原因。药物检测在发现和管理中毒患者方面发挥着核心作用，能够迅速查明病因并及时采取有针对性的治疗有可能降低发病率和挽救生命。目前，筛查血液和其他生物液体的有毒药物水平需要标本处理，需要数小时或数天才能从商业实验室获得结果。在救护车或急诊室进行即时、准确、低成本的紧急护理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接触点以低成本进行，并且可扩展为快速商业和临床采用，进入价值11亿美元的全球药物筛选市场。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，报告真实的-使用廉价的一次性测试条（类似于糖尿病血糖仪）或唾液（如舌下电子温度计）对血液中的有毒药物水平进行实时和准确的定量。目前的药物毒性测定使用专门的实验室方法，需要血液样本处理，可能需要数小时至数天才能获得结果。生物传感器是生物学和电子学之间的接口，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）手持式医疗设备，其提供从一滴血或唾液中准确和实时测量临床使用的所有类别的抗精神病药、精神抑制药和抗惊厥药以及其他常见滥用药物的血液水平，2）相对于当前实验室分析方法（例如，该奖项反映了NSF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 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.