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: 9256099
• 负责人: MICHAEL JOHN HEFFERNAN
• 金额: $ 22.44万
• 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 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9256099
• 关键词: Advocate; Air; Analgesics; Antibodies; Awareness; Biological Assay; Buffers; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinical; Collaborations; Detection; Devices; Diagnosis; Dose; Economics; Enzyme-Linked Immunosorbent Assay; Epidemic; Face; Health; Healthcare Systems; High Pressure Liquid Chromatography; Human Resources; Immunoassay; Individual; Laboratories; Legal patent; Liquid substance; Magnetic nanoparticles; Mass Fragmentography; Movement; Narcotics; Opiates; Opioid; Outpatients; Overdose; Pain; Pain management; Pathology; Patients; Pattern; Performance; Pharmaceutical Preparations; Phase; Physicians; Physicians' Offices; Process; Quality of life; Reagent; Recommendation; Risk; Robotics; Running; Sampling; Secure; Small Business Innovation Research Grant; Statistical Data Interpretation; System; Techniques; Technology; Testing; Time; Toxic effect; Tracer; United States; Urine; Variant; Visit; antibody conjugate; assay development; base; chronic pain; combat; cost; design; drug misuse; drug testing; experience; field study; heroin overdose; innovation; liquid chromatography mass spectrometry; operation; opioid abuse; opioid misuse; opioid use; point of care; portability; prescription drug abuse; prescription opioid; prescription opioid misuse; programs; rapid diagnosis; response; screening; tool; urinary

PROJECT SUMMARY The United States is in the midst of a prescription opioid epidemic. Deaths from misuse (51 daily) exceed deaths from heroin overdose and account for nearly one-fifth of all drug-related deaths. The estimated burden on the US healthcare system was $9.5 billion in 2005 and increased to an estimated $72.5 billion annually in 2014. A key recommendation of several federal agencies is to use urine drug testing (UDT) before prescribing opioids to establish overdosing (above expected levels of opioids in urine) or misuse with intent to resell (low or absent opioids despite patient claims to the contrary). Current strategy for UDT involves a qualitative screening immunoassay, followed by quantification using HPLC or GC/MS for positive cases. Screening immunoassays use benchtop analyzers that require experienced personnel, time, and a laboratory setup. Physicians who do not have access to in-house testing have to send out patient samples for screening. Thus, laboratory testing of every patient suffering from chronic pain at every visit imposes unacceptable delays to treatment and is not followed by most physicians. A quick, affordable, layman operable, point of care UDT in the physician's office will help in rapid diagnosis of problems and potentially halt the epidemic. BreviTest Technologies has developed a low-cost, portable analyzer to perform a rapid, quantitative ELISA test within a 10-minute run time. The sample is loaded into a cartridge that is placed in the analyzer, and a robotic mechanism controls the movement of antibody-conjugated magnetic nanoparticles through successive fluid wells, where enhanced mixing patterns substantially reduce the time required for each ELISA step. This innovative approach enables the implementation of a rapid, portable, fully automated ELISA test with accuracy comparable to a standard laboratory ELISA. In this SBIR Phase I project, BreviTest will develop and optimize an ELISA test for opioids in urine using the BreviTest robotic analyzer. The Specific Aims for the project are: (1) Develop a competitive ELISA for opioids using the BreviTest analyzer platform. We will determine the optimal reagent concentrations for the immunoassay and characterize performance of the assay in the BreviTest platform. Performance parameters will include dynamic range, repeatability, and limit of quantification. (2) Perform a limited proof-of- concept field study of the analyzer on de-identified urine samples in collaboration with a local pathology laboratory. BreviTest offers a unique platform to create an ELISA test for performing rapid quantifications of urine drug levels at the physician's office, which will be an invaluable tool to render more effective dosing to patients, paving the way towards lower toxicity and a better quality of life.

项目概要 美国正处于处方阿片类药物流行之中。滥用造成的死亡人数（每天 51 人）超过 因吸食海洛因过量而死亡，占所有与毒品有关的死亡的近五分之一。预计负担 2005 年美国医疗保健系统的投入为 95 亿美元，2017 年估计每年增加到 725 亿美元。 2014 年。几个联邦机构的一项重要建议是在处方前使用尿液药物检测 (UDT) 阿片类药物过量（尿液中阿片类药物的预期水平高于预期）或意图转售的滥用（低或 尽管患者声称相反，但没有阿片类药物）。当前的 UDT 策略涉及定性筛选 免疫测定，然后使用 HPLC 或 GC/MS 对阳性病例进行定量。筛选免疫分析 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。这样做的医生 无法进行内部检测，必须寄出患者样本进行筛查。因此，实验室测试 每位患者每次就诊时都会遭受慢性疼痛，这都会导致治疗延误，这是不可接受的， 其次是大多数医生。医生办公室内快速、经济实惠、非专业人士可操作的护理点 UDT 将有助于快速诊断问题并有可能阻止流行病。 BreviTest 技术公司拥有 开发了一种低成本便携式分析仪，可在 10 分钟运行时间内执行快速定量 ELISA 测试。 将样品装入分析仪中的卡盒中，然后由机器人机构控制 抗体偶联的磁性纳米颗粒通过连续的流体井的运动，其中增强 混合模式大大减少了每个 ELISA 步骤所需的时间。这种创新方法使 实施快速、便携式、全自动 ELISA 测试，其准确度可与标准相媲美 实验室ELISA。在这个 SBIR 第一阶段项目中，BreviTest 将开发和优化阿片类药物的 ELISA 测试 使用 BreviTest 机器人分析仪进行尿液分析。该项目的具体目标是：（1）开发具有竞争力的 使用 BreviTest 分析仪平台对阿片类药物进行 ELISA。我们将确定最佳试剂浓度 用于免疫测定并表征 BreviTest 平台中测定的性能。表现 参数包括动态范围、重复性和定量限。 (2) 执行有限的证明- 与当地病理学合作对去识别尿样分析仪进行概念现场研究 实验室。 BreviTest 提供了一个独特的平台来创建 ELISA 测试，以执行快速定量 医生办公室的尿液药物水平，这将是一个非常宝贵的工具，可以为患者提供更有效的剂量 患者，为降低毒性和提高生活质量铺平道路。