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

项目总结 布雷迪测试技术公司建议开发一种低成本的护理点(POC)尿液药物检测 (UDT)检测阿片类药物的设备。测试平台的目标是提供量化性能 类似于标准的实验室酶联免疫吸附试验。第一阶段的研究和开发显示了可重复性 和精确度，因为它的专利化验技术。目前的药物筛选免疫分析方法 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。内科医生 在无法进行内部检测的情况下，必须将患者样本送出进行筛查，导致 对可能患有慢性疼痛的患者的治疗延误是不可接受的。因此， 大多数医生以前没有遵循联邦的建议使用尿液药物检测(UDT) 开出阿片类药物以确定潜在的阿片类药物滥用，要么是由于过量(高于预期水平) 尿液中阿片类药物)或打算转售(低阿片类药物或不含类阿片类药物，尽管患者声称有相反的说法)。 布雷迪测试技术公司开发了一种低成本、外行可操作的POC分析仪，用于执行 在10分钟的运行时间内进行定量ELISA法检测。样本被装入盒中，该盒是 放置在分析仪中，自动机制控制抗体偶联的运动 磁性微粒通过具有增强混合模式的连续流体井。这是一项创新 该方法可实现快速、便携、全自动、准确的酶联免疫吸附试验 可与标准的实验室酶联免疫吸附试验相媲美。本二期工程的具体目标是：(1) 根据以下内容完成重复性和校准协议的开发和实施 诊断设备和一次性测试试纸的行业标准；(2)制造和表征 完全集成的原型，以获得最终的设备设计、包装、工艺和工具；(3) 使用患者的尿样对最终的闪光测试设备进行测试并进行性能验证。 该项目的预期结果将是设计用于制造的设备(DFM)、制造和 以合同制造商为特征，在试点研究和用户模拟中得到验证，随时准备 进入设计控制，并制定了监管和商业化道路。布莱维测试提供了一个 独一无二的平台创建了一种用于快速定量尿药浓度的酶联免疫吸附试验 医生的办公室，提供了一个宝贵的工具来提供更有效的疼痛管理剂量 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.