Sensitive and Portable Physician Office-Based Urine Analyzer to Tackle Prescription Drug Abuse

灵敏的便携式医生办公室尿液分析仪可解决处方药滥用问题

• 批准号: 9884752
• 负责人: MICHAEL JOHN HEFFERNAN
• 金额: $ 51.13万
• 依托单位: BREVITEST TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2020-12-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9884752
• 关键词: Accident and Emergency department; Advocate; Air; Analgesics; Awareness; Biological Assay; Calibration; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Contracts; Development; Device Designs; Devices; Diagnostic; Dimensions; Dose; Drug Screening; Economics; Environment; Enzyme-Linked Immunosorbent Assay; Epidemic; Evaluation; Face; Freezing; Goals; Health; Healthcare Systems; High Pressure Liquid Chromatography; Human Resources; Immunoassay; Individual; Industry Standard; Institutional Review Boards; Laboratories; Legal patent; Life; Liquid substance; Magnetic nanoparticles; Magnetism; Manufacturer Name; Mass Fragmentography; Methods; Movement; Narcotics; Opioid; Opioid Analgesics; Outcome; Outpatients; Overdose; Pain; Pain Clinics; Pain management; Patients; Pattern; Performance; Pharmaceutical Preparations; Phase; Physicians; Physicians' Offices; Pilot Projects; Private Practice; Process; Protocols documentation; Public Health; Quality of life; Reagent; Recommendation; Risk; Running; Sampling; Screening Result; Secure; Shipping; Site; Small Business Innovation Research Grant; Sterility; Technology; Testing; Time; Toxic effect; United States; Urine; Validation; antibody conjugate; base; chronic pain; commercialization; cost; cross reactivity; design; drug testing; experience; innovation; manufacturing scale-up; misuse of prescription only drugs; opioid abuse; opioid overdose; point of care; point-of-care diagnostics; portability; prescription drug abuse; prescription opioid; prescription opioid misuse; prescription pain reliever; prototype; research and development; research clinical testing; response; screening; simulation; tool; trial design; urinary; validation studies; waiver

PROJECT SUMMARY BreviTest Technologies, LLC, proposes to develop a low-cost, point-of-care (POC) urine drug testing (UDT) device to detect opioids. The goal is for the assay platform to deliver quantitative performance similar to a standard laboratory ELISA. Phase I research and development showed the repeatability and accuracy of BreviTest’s proprietary assay technology. Current drug-screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians without access to in-house testing have to send out patient samples for screening, resulting in unacceptable delays in the treatment of patients who are potentially suffering from chronic pain. Thus most physicians do not follow the federal recommendations to use urine drug testing (UDT) before prescribing opioids to identify potential opioid abuse, either from overdosing (above expected levels of opioids in urine) or intent to resell (low or absent opioids despite patient claims to the contrary). BreviTest Technologies has developed a low-cost, layman operable, POC analyzer to perform a quantitative ELISA test within a 10-minute run time. The sample is loaded into a cartridge that is placed in the analyzer and an automated mechanism controls the movement of antibody-conjugated magnetic microparticles through successive fluid wells with enhanced mixing patterns. This innovative approach enables the implementation of a rapid, portable, fully automated ELISA test with accuracy comparable to a standard laboratory ELISA. The Specific Aims for this Phase II project are: (1) Finalize development and implementation of repeatability and calibration protocols according to industry standards for the diagnostic device and disposable test cartridges; (2) Build and characterize fully integrated prototypes to obtain a finalized device design, packaging, process, and tooling; (3) Perform testing of finalized BreviTest device and performance validation using patient urine samples. The expected outcome of this project will be a device designed for manufacturing (DFM), built and characterized by a contract manufacturer, validated in a pilot study and user simulation, ready to enter design controls, and with a regulatory and commercialization path in place. BreviTest offers a unique platform to create an ELISA test for performing rapid quantifications of urine drug levels in a physician’s office, providing an invaluable tool to render more effective pain management dosing to patients, thus paving the way towards lower toxicity and a better quality of life.

项目概要 BreviTest Technologies, LLC 提议开发一种低成本的即时护理 (POC) 尿液药物检测 （UDT）设备检测阿片类药物，目标是让检测平台提供定量性能。 与标准实验室 ELISA 相似，第一阶段研究和开发显示出可重复性。 BreviTest 专有检测技术的准确性。 使用需要经验丰富的人员、时间和实验室设置的台式分析仪。 如果无法进行内部检测，则必须发送患者样本进行筛查，从而导致 因此，对可能遭受慢性疼痛的患者的治疗造成了不可接受的延误。 大多数医生在使用尿液药物检测 (UDT) 之前并未遵循联邦建议 开阿片类药物以确定潜在的阿片类药物滥用，无论是过量服用（高于预期水平） 尿液中含有阿片类药物）或意图转售（阿片类药物含量低或不存在，尽管患者声称相反）。 BreviTest Technologies 开发了一种低成本、非专业人士可操作的 POC 分析仪来执行 10 分钟运行时间内进行 ELISA 测试 将样品装入试剂盒中。 放置在分析仪中，自动化机制控制抗体缀合的运动 磁性微粒通过连续的流体井，具有增强的混合模式。 方法能够实现快速、便携式、全自动、准确的 ELISA 测试 与标准实验室 ELISA 相当，该 II 期项目的具体目标是：(1) 根据以下内容完成重复性和校准协议的开发和实施 (2) 建立并表征诊断设备和一次性检测盒的行业标准； (3) 完全集成原型以获得最终的器件设计、封装、工艺和工具； 使用患者尿液样本对最终的 BreviTest 设备进行测试并进行性能验证。 该项目的预期成果将是设计用于制造 (DFM)、建造和使用的设备 由合同制造商表征，经过试点研究和用户模拟验证，准备好 进入设计控制，并通过适当的监管和商业化路径提供了一个。 创建 ELISA 测试的独特平台，用于快速定量尿液中的药物水平 医生办公室，提供了一个宝贵的工具，可以为患者提供更有效的疼痛管理剂量 患者，从而为降低毒性和提高生活质量铺平道路。