Rapid and non-invasive device for drug detection through sweat

通过汗液快速、非侵入性检测药物的装置

• 批准号: 10544121
• 负责人: Girish Kulkarni
• 金额: $ 86.87万
• 依托单位: ARBORSENSE, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10544121
• 关键词: Accident and Emergency department; Address; Amphetamines; Award; Benchmarking; Biological Assay; Biomedical Engineering; Biomedical Research; Blood Tests; Buprenorphine; COVID-19 impact; Caring; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Collection; Consent; Core Facility; Coupled; Crime; Data; Data Reporting; Detection; Development; Device Designs; Devices; Drug Monitoring; Drug Screening; Drug Use Disorder; Drug usage; Economics; Ensure; Enzyme-Linked Immunosorbent Assay; Epidemic; Financial Hardship; Funding; Generations; Hair; Hand; Health; Healthcare; Hospitals; Human; Individual; Industry Standard; Iontophoresis; Knowledge; Lead; Life; Liquid Chromatography; Manuals; Mass Spectrum Analysis; Measurement; Mechanics; Methadone; Methamphetamine; Methods; Michigan; Microfluidics; Monitor; National Institute of Drug Abuse; Opioid; Outpatients; Overdose; Participant; Patient Self-Report; Patients; Performance; Persons; Pharmaceutical Preparations; Phase; Pilocarpine; Process; Productivity; Protocols documentation; Psychiatry; Public Health; Pump; Reagent; Reporting; Safety; Saliva; Sampling; Small Business Innovation Research Grant; Study Subject; Substance Abuse Detection; Substance abuse problem; Sweat test; Technology; Test Result; Testing; Tetrahydrocannabinol; Time; United States; United States National Institutes of Health; Universities; Urine; Withdrawal; Work; Workplace; abuse liability; addiction; amphetamine use; base; clinically relevant; commercialization; cost; court; design; detection limit; detector; drug testing; drug use screening; eligible participant; field study; human study; human subject; industry partner; interest; marijuana legalization; marijuana use; methamphetamine use; operation; portability; prototype; rapid detection; recruit; remote monitoring; screening; sobriety; social; social stigma; substance misuse; substance use; substance use treatment; success; telehealth; tool; treatment adherence; treatment center

Project Summary In this NIH SBIR Phase II project, Arborsense will continue its successful line of work to develop a portable sweat-based screening device to address the unmet need for a rapid, non-invasive, and quantitative device for detection of drugs of abuse at point-of-need. The use and abuse of potentially addictive substances has become a national crisis. The tremendous social (100,000 deaths reported by CDC between April 2020 and April 2021) and economic ($400B annually in healthcare, work productivity, and crime) costs related to the substance abuse and misuse call for an urgent focus on implementing and supporting health approaches to reduce the loss of life and financial burden inflicted. Regular drug-use testing and monitoring are key components of the management strategies to control this epidemic. Within most settings whether clinical, court-ordered, treatment centers, workplace monitoring, or roadside testing, having reliable and timely data on drug use is essential. However, the available strategies to detect drug use which rely on testing blood, urine, saliva, hair, breath, and sweat, are plagued by cumbersome collection methods and significant delays in receiving test results, thus hampering the ability to provide up-to-date objective data on recent drug use. Based on the preliminary study on rapid and quantitative detection of 4 drugs/opioids in artificial sweat, Arborsense received a NIDA Phase I SBIR (R43 DA052941) award. In Phase I, we: (1) expanded the panel to 5th drug - Buprenorphine, (2) optimized the sweat analysis protocol, (3) developed sweat generation and sweat collection modules, and (4) validated the detector in a human subjects’ study (n=16) benchmarking it with a urine drug screen where we demonstrated point-of- need generation (5 minutes) and collection (15 minutes) of 20 µL of sweat and subsequent detection (20 minutes) of 5 drugs with detection limits of 1-3 ng/mL. Based on these results, in Phase II Arborsense will further optimize the overall device design and workflow to develop a truly portable robust prototype and benchmark it with the industry-standard LC-MS (liquid chromatography coupled with mass spectrometry) in a large-scale human subjects’ study (n=50). Specifically, we will reduce the size of the sweat generator to a hand-held unit and sweat detector to a shoebox size unit. We will automate the microfluidic flow to eliminate mechanical moving parts and optimize the unit to target a start-to-finish time of 25 minutes. The overall design will also reduce multiple manual touchpoints for ease-of-operation. In Phase II, Arborsense will collaborate with Biomedical Engineering and Department of Psychiatry at University of Michigan to design, co-develop, and validate the portable sweat-based detector in a large-scale human study. We will also engage with our strategic industry partners during the design process to incorporate features necessary for market acceptance. Good correspondence between our detector and LC-MS measurements will confirm the technical and commercial feasibility of our detector, which can then be provided to industry partners for testing and pitched to investors.

项目摘要 在这个NIH SBIR II阶段项目中，Arborsense将继续其成功的工作线以开发便携式 基于汗水的筛查设备，以满足对快速，非侵入性和定量设备的未满足需求 在需要的时候发现滥用药物。使用和滥用潜在的其他物质已成为 国家危机。巨大的社会（2020年4月至2021年4月之间疾病预防控制中心报告的100,000人死亡） 和经济（每年400B美元的医疗保健，工作效率和犯罪）费用与药物滥用有关 滥用要求紧急关注实施和支持健康方法以减少生命的损失 财务烧毁。定期的药物使用测试和监测是管理的关键组成部分 控制这种流行病的策略。在大多数情况下，无论是临床，法院命令，治疗中心， 工作场所监测或路边测试，具有可靠且及时的吸毒数据是必不可少的。但是， 可用的策略来检测依靠测试血液，尿液，唾液，头发，呼吸和汗水的药物使用 繁琐的收集方法困扰和接收测试结果的重大延迟，从而阻碍了 能够提供有关最近使用药物的最新客观数据。基于关于快速和快速和 对人造汗液中4种药物/阿片类药物的定量检测，Arborsense接受了NIDA阶段I SBIR（R43 DA052941）奖。在第一阶段，我们：（1）将面板扩展到第五药物 - 丁丙诺啡，（2）优化了甜味 分析协议，（3）开发了汗水产生和汗水收集模块，（4）验证了检测器 在人类受试者的研究（n = 16）中，用尿液药物筛查进行了基准测试 需要生成（5分钟）和20 µL汗液的收集（15分钟），然后检测（20分钟） 5个药物的检测限为1-3 ng/ml。基于这些结果，在第二阶段Arborsense中将进一步优化 整体设备设计和工作流程，以开发真正便携式可靠的稳健原型，并用 大型人类的行业标准LC-MS（液相色谱和质谱法） 受试者的研究（n = 50）。特别是，我们将把汗水发生器的大小减少到手持式单元和甜蜜 探测器到鞋盒尺寸单元。我们将自动化微流体流以消除机械运动部件，并 优化该单元的目标时间为25分钟。总体设计还将减少多个手册 接触点，以易于操作。在第二阶段，Arborsense将与生物医学工程和 密歇根大学精神病学系设计，共同开发和验证基于便携式汗水 大规模研究中的探测器。在设计期间，我们还将与战略行业合作伙伴互动 纳入市场接受必要的功能的过程。我们的检测器之间的良好对应关系 LC-MS测量结果将确认我们的检测器的技术和商业可行性，然后可以 向行业合作伙伴提供测试，并向投资者提供。