Rapid and non-invasive device for drug detection through sweat

项目摘要 在NIDA SBIR第一阶段项目中，Arborense将开发一种便携式汗液筛查设备，用于快速、 对滥用药物的非侵入性、需求点和定量检测。使用和滥用潜在的- 令人上瘾的物质已经成为一种国家危机，具有巨大的社会和经济后果(2020年约93,000人死亡) 成本(每年约4000亿美元)。因此，定期药物使用测试和监测已成为关键组成部分。 控制这一流行病的管理策略。在大多数情况下，无论是临床、路边测试， 工作场所监测，或法院命令的遵守，拥有可靠和及时的药物使用数据是至关重要的。 然而，现有的检测药物使用的策略依赖于检测血液、尿液、唾液、头发、呼吸和 汗水，被繁琐的收集方法和在接收检测结果方面的重大延误所困扰，因此 妨碍提供有关最近药物使用情况的最新客观数据的能力。在这个项目中，Arborense 建议使用我们的技术开发一种基于汗液的便携且廉价的毒品检测设备 前面板收集汗液的微流控竞争酶联免疫吸附试验 量化结果将在几分钟内公布。在初步研究中，我们已经证明 人工汗液中药物/阿片类药物的快速定量检测。对于这项第一阶段的研究，Arborense将 与密歇根大学合作开发和验证我们的便携式汗液药物探测器。第一, 我们将设计、测试、优化和自动化一个集成了汗水产生的微型毒品检测单元 和收集模块。接下来，我们将在20名正在寻找的人类参与者身上验证设备和协议 治疗药物使用障碍，并用尿液药物筛查和自我报告的数据作为结果的基准。一个 Arborense的设备、尿液测试和自我报告数据之间的高度一致性将证实 我们提议的项目的可行性，并将导致第二阶段SBIR应用，以优化现场使用的设备 然后可以在大规模的临床研究中进行评估。我们设想的产品将满足未得到满足的需求 用于快速检测使用/滥用的非侵入性、实时、定量、使用点和方便的设备 多种药物的结合。这样的设备具有与药物使用严重程度谱上的所有点相关的应用 并将有助于加强预防和治疗战略，增进健康，减少疾病和 残疾。在NIH i-Corps计划中，我们将采访生态系统中的100个个体利益相关者，以测试我们的 关于市场痛点、目标进入市场、产品需求、竞争和收入模式的假设。这个 从i-Corps计划获得的反馈将用于改进和重新调整我们现有的业务计划，以 最大限度地实现商业化成功。

Project Summary In the NIDA SBIR Phase I project, Arborsense will develop a portable sweat-based screening device for rapid, non-invasive, point-of-need, and quantitative detection of drugs of abuse. The use and abuse of potentially- addictive substances has become a national crisis with immense social (~93,000 deaths in 2020) and economic costs (~$400B annually). Consequently, regular drug-use testing and monitoring have become key components of the management strategies to control this epidemic. Within most settings whether clinical, roadside tests, workplace monitoring, or court-ordered compliance, 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. In this project, Arborsense proposes to develop a sweat-based portable and inexpensive drug detection device using our technology based on microfluidic competitive enzyme-linked immunosorbent assay where sweat will be collected on the front panel and quantitative results will be available within a few minutes. In preliminary studies, we have demonstrated rapid and quantitative detection of drugs/opioids in artificial sweat. For this Phase I study, Arborsense will collaborate with the University of Michigan to develop and validate our portable sweat-based drug detector. First, we will design, test, optimize and automate a miniaturized drug detection unit integrated with sweat generation and collection modules. Next, we will validate the device and protocol on 20 human participants who are seeking treatment for a drug use disorder and benchmark the results with urine drug screens and self-reported data. A high degree of concordance between Arborsense’s device, urine test, and self-reported data will confirm the feasibility of our proposed project, and will lead to a Phase II SBIR application to optimize the device for field use which can then be evaluated in large scale clinical studies. Our envisioned product will address the unmet need for a non-invasive, real-time, quantitative, point-of-use, and convenient device for rapid detection of use/abuse of multiple drugs. Such a device has applications related to all points along the spectrum of severity of drug use problems and will help augment prevention and treatment strategies, enhance health, and reduce illness and disability. In the NIH I-Corps program, we will interview 100 individual stakeholders in the ecosystem to test our hypotheses on the market pain-points, target entry market, product needs, competition, and revenue model. The feedback gained from the I-Corps program will be used to refine and realign our existing business plan to maximize commercialization success.