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: 10540571
• 负责人: Girish Kulkarni
• 金额: $ 5.5万
• 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 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10540571
• 关键词: Address; Benchmarking; Blood Tests; Businesses; Cessation of life; Clinical; Clinical Research; Collection; Crime; Data; Data Reporting; Devices; Drug Screening; Drug Use Disorder; Drug usage; Ecosystem; Enzyme-Linked Immunosorbent Assay; Epidemic; Feedback; Generations; Grant; Hair; Health; Health Expenditures; Human; Individual; Innovation Corps; Interview; Methods; Michigan; Microfluidics; Modeling; Monitor; National Institute of Drug Abuse; Opioid; Pain; Participant; Patient Self-Report; Pharmaceutical Preparations; Phase; Prevention strategy; Productivity; Protocols documentation; Saliva; Severities; Small Business Innovation Research Grant; Substance Abuse Detection; Technology; Test Result; Testing; Time; United States; United States National Institutes of Health; Universities; Urine; Work; Workplace; abuse liability; base; commercialization; cost; court; design; detector; disability; drug testing; economic cost; economic impact; miniaturize; multidrug abuse; phase 1 study; portability; programs; rapid detection; screening; social; success; treatment strategy

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.

项目摘要 在NIDA SBIR I期项目中，Arborsense将开发一种基于便携式汗液的筛查设备，以用于快速， 对滥用药物的无创，需要和定量检测。潜在的使用和滥用 加性物质已成为一场巨大社会（2020年约93,000人）和经济的国家危机 费用（每年〜$ 400B）。因此，常规的药物使用测试和监测已成为关键组成部分 控制这种流行病的管理策略。在大多数设置中，无论是临床，路边测试， 工作场所监控或法院命令的合规性，具有可靠和及时的毒品数据数据至关重要。 但是，检测依赖于测试血液，尿液，唾液，头发，呼吸的药物使用的可用策略 汗水受到麻烦的收集方法困扰，并在接受测试结果中的重大延迟，因此 妨碍提供有关最近使用药物的最新目标数据的能力。在这个项目中，Arborsense 建议使用我们的技术开发基于汗水的便携式和廉价的药物检测装置 在微流体竞争性酶相关的免疫吸附测定法上，将在前面板上收集汗水 定量结果将在几分钟之内获得。在初步研究中，我们已经证明 人造汗液中药物/阿片类药物的快速和定量检测。对于I阶段的研究，Arborsense将 与密歇根大学合作开发和验证我们的基于汗水的药物检测器。第一的， 我们将设计，测试，优化和自动化一个小型药物检测单元，该药物检测单元与汗液产生集成 和收集模块。接下来，我们将验证20名寻求的人类参与者的设备和协议 治疗药物使用障碍和基准测试尿液药物筛查和自我报告的数据的结果。一个 Arborsense设备，尿液测试和自我报告的数据之间的高度一致性将确认 我们建议的项目的可行性，并将导致II期SBIR应用程序以优化现场使用的设备 然后可以在大规模的临床研究中评估。我们设想的产品将满足未满足的需求 用于非侵入性，实时，定量，使用点和方便的设备，用于快速使用/滥用 多种药物。这样的设备具有与药物使用严重程度相关的所有点的应用 问题并将有助于增加预防和治疗策略，增强健康并减少疾病和 残疾。在NIH I-Corps计划中，我们将采访生态系统中的100个个人利益相关者，以测试我们 关于市场痛点，目标进入市场，产品需求，竞争和收入模型的假设。 从I-Corps计划中获得的反馈将用于完善和重新调整我们现有的业务计划 最大化商业化成功。