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

基本信息

  • 批准号:
    9884752
  • 负责人:
  • 金额:
    $ 51.13万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(6)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

MICHAEL JOHN HEFFERNAN其他文献

MICHAEL JOHN HEFFERNAN的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('MICHAEL JOHN HEFFERNAN', 18)}}的其他基金

Bedside right-heart catheterization for early diagnosis and more effective management of patients with heart failure and primary pulmonary hypertension
床边右心导管检查可对心力衰竭和原发性肺动脉高压患者进行早期诊断和更有效的治疗
  • 批准号:
    10696663
  • 财政年份:
    2023
  • 资助金额:
    $ 51.13万
  • 项目类别:
Uterine Wall-Membrane Anchor Device for the Prevention of Preterm Premature Rupture of the Membranes Following Fetoscopic Surgery
子宫壁膜锚定装置用于预防胎儿镜手术后子宫膜过早破裂
  • 批准号:
    10301644
  • 财政年份:
    2021
  • 资助金额:
    $ 51.13万
  • 项目类别:
Southwest National Pediatric Device Consortium
西南国家儿科设备联盟
  • 批准号:
    10466837
  • 财政年份:
    2018
  • 资助金额:
    $ 51.13万
  • 项目类别:
Southwest National Pediatric Device Consortium
西南国家儿科设备联盟
  • 批准号:
    10468511
  • 财政年份:
    2018
  • 资助金额:
    $ 51.13万
  • 项目类别:
Southwest National Pediatric Device Consortium
西南国家儿科设备联盟
  • 批准号:
    10247488
  • 财政年份:
    2018
  • 资助金额:
    $ 51.13万
  • 项目类别:
Southwest National Pediatric Device Consortium
西南国家儿科设备联盟
  • 批准号:
    10683882
  • 财政年份:
    2018
  • 资助金额:
    $ 51.13万
  • 项目类别:
Southwest National Pediatric Device Consortium
西南国家儿科设备联盟
  • 批准号:
    9768952
  • 财政年份:
    2018
  • 资助金额:
    $ 51.13万
  • 项目类别:
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
  • 财政年份:
    2017
  • 资助金额:
    $ 51.13万
  • 项目类别:
Uterine Wall-Membrane Anchor Device for the Prevention of Preterm Premature Rupture of the Membranes Following Fetoscopic Surgery
子宫壁膜锚定装置用于预防胎儿镜手术后子宫膜过早破裂
  • 批准号:
    9981774
  • 财政年份:
    2017
  • 资助金额:
    $ 51.13万
  • 项目类别:
Curbside Immunoassay Device for Quantitative Measurement of Cannabis Intoxication
用于定量测量大麻中毒的路边免疫测定装置
  • 批准号:
    9141902
  • 财政年份:
    2016
  • 资助金额:
    $ 51.13万
  • 项目类别:

相似海外基金

Optimizing Health and Well-Being of Diverse Mothers with IDD and Their Infants During the Perinatal Period: A Virtual Advocate Tool for Data-Driven Supports
优化患有 IDD 的不同母亲及其婴儿在围产期的健康和福祉:用于数据驱动支持的虚拟倡导工具
  • 批准号:
    10760051
  • 财政年份:
    2023
  • 资助金额:
    $ 51.13万
  • 项目类别:
POSE: Phase II: Advocate Led Long-term Gameplan for Open OnDemand (ALL GOOD)
POSE:第二阶段:倡导者主导 Open OnDemand 的长期游戏计划(一切顺利)
  • 批准号:
    2303692
  • 财政年份:
    2023
  • 资助金额:
    $ 51.13万
  • 项目类别:
    Standard Grant
Capitalising on our differences: A gathering to better understand and advocate for Early Career Health Researchers in Canada
利用我们的差异:更好地理解和倡导加拿大早期职业健康研究人员的聚会
  • 批准号:
    468168
  • 财政年份:
    2022
  • 资助金额:
    $ 51.13万
  • 项目类别:
    Miscellaneous Programs
Addressing social adversity to improve outcomes among children undergoing liver transplant: the role for a health advocate on the transplant team
解决社会逆境以改善接受肝移植的儿童的预后:移植团队中健康倡导者的作用
  • 批准号:
    10427960
  • 财政年份:
    2022
  • 资助金额:
    $ 51.13万
  • 项目类别:
Evaluating an ACEs-Targeting Advocate Model of a Substance Use Prevention Program
评估药物使用预防计划的针对 ACE 的倡导者模型
  • 批准号:
    10577074
  • 财政年份:
    2022
  • 资助金额:
    $ 51.13万
  • 项目类别:
The Art of Creation: Using Art-Based Knowledge Translation to Promote and Advocate for a Healthy Start to Life
创造的艺术:利用基于艺术的知识转化来促进和倡导健康的生命开端
  • 批准号:
    486588
  • 财政年份:
    2022
  • 资助金额:
    $ 51.13万
  • 项目类别:
    Studentship Programs
When I am Old, I shall Wear Purple Nail Varnish: Utilising performance art to construct queer spaces that celebrate and advocate for ageing bodies
当我老了,我要涂紫色指甲油:利用行为艺术构建酷儿空间,庆祝和倡导衰老的身体
  • 批准号:
    2760091
  • 财政年份:
    2022
  • 资助金额:
    $ 51.13万
  • 项目类别:
    Studentship
Addressing social adversity to improve outcomes among children undergoing liver transplant: the role for a health advocate on the transplant team
解决社会逆境以改善接受肝移植的儿童的预后:移植团队中健康倡导者的作用
  • 批准号:
    10621188
  • 财政年份:
    2022
  • 资助金额:
    $ 51.13万
  • 项目类别:
Techquity by FAITH!: A cluster randomized controlled trial to assess the efficacy of a community-informed, cardiovascular health promotion mobile hlth intervention with digital health advocate support
Techquity by FAITH!:一项整群随机对照试验,旨在评估社区知情、心血管健康促进移动 hlth 干预措施在数字健康倡导者支持下的效果
  • 批准号:
    10891016
  • 财政年份:
    2021
  • 资助金额:
    $ 51.13万
  • 项目类别:
CMV responses in autoantibody positive subjects advocate antiviral treatments for prevention of T1D
自身抗体阳性受试者的 CMV 反应主张抗病毒治疗以预防 T1D
  • 批准号:
    10230365
  • 财政年份:
    2020
  • 资助金额:
    $ 51.13万
  • 项目类别:
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了