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

项目摘要 BreviTest Technologies，LLC建议开发一种低成本的即时（POC）尿液药物检测 (UDT)检测阿片类药物的设备目标是让检测平台提供定量性能 类似于标准实验室ELISA。第一阶段的研究和开发表明， BreviTest专有检测技术的准确性。当前药物筛选免疫测定 使用需要有经验的人员、时间和实验室设置的台式分析仪。医生 无法获得内部检测的患者必须将患者样本送去筛查， 对可能患有慢性疼痛的患者的治疗出现不可接受的延误。因此 大多数医生不遵循联邦建议使用尿液药物检测（UDT）之前， 处方阿片类药物，以确定潜在的阿片类药物滥用，无论是过量（高于预期水平 尿液中含有阿片类药物）或意图转售（尽管患者声称相反，但阿片类药物含量低或不存在）。 BreviTest Technologies开发了一种低成本、非专业人员可操作的POC分析仪， 在10分钟的运行时间内进行定量ELISA测试。将样品装载到盒中， 放置在分析仪中，并且自动化机构控制抗体缀合物的移动， 磁性微粒通过具有增强的混合模式的连续流体威尔斯。这一创新 该方法能够实现快速、便携、全自动化的ELISA检测， 与标准实验室ELISA相当。第二期工程的具体目标是：（1） 完成重复性和校准方案的开发和实施， 诊断设备和一次性测试盒的行业标准;（2）构建和表征 完全集成的原型，以获得最终的器件设计、封装、工艺和工具;（3） 使用患者尿液样本对最终BreviTest器械进行测试和性能确认。 该项目的预期成果将是一种专为制造而设计（DFM）的器械， 其特点是合同制造商，在试点研究和用户模拟中得到验证， 进入设计控制，并有适当的监管和商业化途径。BreviTest提供了 一个独特的平台，以创建ELISA测试，用于执行尿液药物水平的快速定量， 医生的办公室，提供了一个宝贵的工具，使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了道路。

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.