Rapid and non-invasive device for drug detection through sweat

项目摘要 在这个NIH SBIR第二阶段项目中，Arborsense将继续其成功的工作路线，开发一种便携式 基于汗液的筛查设备，以解决对快速、非侵入性和定量设备的未满足需求， 在需要时发现滥用药物。使用和滥用潜在成瘾物质已成为 国家危机。巨大的社会（CDC在2020年4月至2021年4月期间报告的10万例死亡） 和经济（每年在医疗保健、工作效率和犯罪方面的4000亿美元）成本 和滥用呼吁紧急关注实施和支持健康方法，以减少生命损失 造成的经济负担。定期药物使用检测和监测是管理的关键组成部分 控制这种流行病的战略。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检测，掌握可靠和及时的药物使用数据至关重要。但 检测药物使用的现有策略依赖于检测血液、尿液、唾液、毛发、呼吸和汗液， 受繁琐的收集方法和收到测试结果的严重延误的困扰，从而妨碍了 提供关于最近吸毒情况的最新客观数据的能力。本文在对快速、 定量检测人工汗液中的4种药物/阿片类药物，Arborsense接受NIDA I期SBIR（R43 DA 052941）奖。在第一阶段，我们：（1）扩大了小组的第五种药物-丁丙诺啡，（2）优化汗水， 分析协议，（3）开发汗液生成和汗液收集模块，以及（4）验证检测器 在一项人类受试者的研究（n=16）中，我们用尿液药物筛查对其进行了基准测试， 需要产生（5分钟）和收集（15分钟）20微升汗液，并进行后续检测（20分钟） 方法的检出限为1-3 ng/mL。基于这些结果，在第二阶段，Arborsense将进一步优化 整体设备设计和工作流程，以开发真正便携的坚固原型，并将其与 工业标准LC-MS（液相色谱-质谱联用）在大规模人体中的应用 受试者研究（n=50）。具体来说，我们将减少汗液发生器的大小，以一个手持单位和汗水 探测器到一个鞋盒大小的单位。我们将使微流体流动自动化，以消除机械移动部件， 优化该装置，以实现25分钟的开始到结束时间。整体设计还将减少多个手动 易于操作的接触点。在第二阶段，Arborsense将与生物医学工程合作， 密歇根大学精神病学系设计、共同开发和验证便携式汗液检测仪。 在一项大规模的人类研究中，我们还将在设计过程中与我们的战略行业合作伙伴合作 过程，以纳入市场接受所需的功能。我们的探测器 和LC-MS测量将确认我们的检测器的技术和商业可行性，然后可以 提供给行业合作伙伴进行测试，并向投资者推销。

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.