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第一阶段项目中，Arborsense将开发一种便携式汗液筛查设备， 非侵入性的、按需的和定量的药物滥用检测。使用和滥用潜在的- 成瘾物质已成为一个国家危机，造成巨大的社会（2020年约93，000人死亡）和经济损失。 成本（每年约4000亿美元）。因此，定期药物使用检测和监测已成为关键组成部分 控制疫情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情况，掌握可靠和及时的药物使用数据至关重要。 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， 由于收集方法繁琐和收到检测结果的时间明显延迟， 妨碍提供关于最近吸毒情况的最新客观数据的能力。在这个项目中，Arborsense 建议开发一种基于汗液的便携式和廉价的药物检测设备，使用我们的技术， 在微流控竞争酶联免疫吸附测定中，汗液将被收集在前面板上， 几分钟之内就可以得到定量结果。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I期研究，Arborsense将 与密歇根大学合作开发和验证我们的便携式汗液药物检测仪。第一、 我们将设计、测试、优化和自动化一种集成汗液生成的小型药物检测装置， 收集模块。接下来，我们将在20名人类参与者身上验证该设备和协议， 治疗药物使用障碍，并以尿液药物筛查和自我报告的数据为基准。一 Arborsense设备、尿液检测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 然后可以在大规模临床研究中进行评估。我们设想的产品将解决未满足的需求 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。这样的装置具有与沿着药物使用的严重程度的谱的所有点沿着相关的应用 问题，并将有助于加强预防和治疗战略，增强健康，减少疾病， 残疾。在NIH I-Corps计划中，我们将采访生态系统中的100名个体利益相关者，以测试我们的 市场痛点、目标进入市场、产品需求、竞争和收入模式的假设。的 从I-Corps计划中获得的反馈将用于改进和调整我们现有的业务计划， 最大化商业化成功。