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

SBIR 第一阶段：用于快速检测药物毒性的即时电化学平台

• 批准号: 2124746
• 负责人: Marcin Guzinski
• 金额: $ 25.36万
• 依托单位: INFUSENSE LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-15 至 2022-10-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2124746&HistoricalAwards=false
• 关键词: SBIR; Phase; Point; Care; Electrochemical

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.

这项小型企业创新研究（SBIR）I期项目的更广泛的影响/商业潜力是，处方药中毒每年会影响超过100万人，这是美国与伤害有关的主要原因。除阿片类药物外，开处方的苯二氮卓类药物，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。药物测试在中毒患者的检测和管理中起着核心作用，并且迅速识别原因和迅速靶向治疗的能力有可能降低发病率并挽救生命。当前，对有毒药物水平的血液和其他生物流体进行筛查需要进行标本处理，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紧急护理的立即，准确，低成本的测试将改善意外中毒和自杀未遂后患者的快速诊断和护理结果。 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糖尿病的血糖仪或唾液中的舌下电子温度计。当前的药物毒性测定使用需要血液样本处理的专业实验室方法，并且可能需要数小时到几天才能获得结果。生物传感器是生物学和电子产品之间的界面，这些界面将特定的化学信息转换为可测量的电子信号（例如，糖仪）。该项目的三个具体结果将是； 1）手持医疗装置，可在临床用途中提供所有类别的抗精神病药，神经摄影和抗惊厥药物的血液水平的准确和实时测量通过特定的分析方法和可修改的生物传感器涂层区分药物类别，滥用药物以及血液中潜在的临床干扰。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的智力优点和更广泛影响的审查标准通过评估来进行评估的。