Development of a Point-of-Care Volumetric Bar-Chart Chip for Drug Quantitation

开发用于药物定量的床旁体积条形图芯片

• 批准号: 9922877
• 负责人: Lidong Qin
• 金额: $ 63.48万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-15 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9922877
• 关键词: Acetazolamide; Address; Adherence; Antibodies; Award; Bar Codes; Biological; Biological Assay; Blood; Blood specimen; Calibration; Cellular Phone; Clinic; Clinical; Clinical Sensitivity; Clinical Trials; Cloud Computing; Complex; Computers; Data; Decision Making; Development; Devices; Drug Screening; Drug Targeting; Drug abuse; Environment; Enzyme-Linked Immunosorbent Assay; Equipment; Fingers; Gas Chromatography; Glass; Gold; Grant; Healthcare; Home environment; Hospitals; Illicit Drugs; Image; Immunoassay; Laboratories; Lasers; Legal patent; Liquid Chromatography; Manuals; Measurement; Measures; Medical; Medicine; Methods; Microfabrication; Outpatients; Paper; Patients; Peer Review; Pennsylvania; Pharmaceutical Preparations; Procedures; Process; Production; Publications; Publishing; Pump; Reader; Reading; Saliva; Sampling; Slide; Specificity; Specimen; Spottings; Substance Abuse Detection; Substance Use Disorder; System; Techniques; Technology; Telemedicine; Testing; Therapeutic; Therapeutic Clinical Trial; Time; Treatment Efficacy; University Hospitals; Urine; Validation; Visit; Weight; Whole Blood; base; clinical practice; commercialization; compliance behavior; computerized data processing; cost; design; drug testing; improved; innovation; instrument; instrumentation; internal control; mass spectrometer; meter; miniaturize; minimally invasive; operation; point of care; portability; research and development; sample collection; screening; user-friendly

Abstract Resubmission: Develop Point-of-Care Volumetric-Bar-Chart-Chip for Drug Quantitation This proposal is a resubmission of a three-year R01 (DA035868-01) renewal. During the last grant period, we published 40 peer-reviewed papers and applied for 4 patents, with 17 publications and 2 patents directly resulted from this grant award support. We still have numerous raw data and 4 pending publications from this grant. The original patent featured in the grant, Volumetric-Bar-Chart-Chip (V-Chip) patent, was officially issued in 2015 (US9097710 B2) and licensed to Etta Healthcare and Ovagen. Our lab chip system is also a winner of 2015 R&D 100 award. In the resubmission, we focus on further developing the quantitation capability and point- of-care user friendliness of the V-Chip platform for drug quantitation. Key innovations and changes we incorporated to address the reviewers' concerns include: 1. Improving the design of the V-chip so that the device is more robust for quantitation and user-friendly in a point of care setting. This includes modifying the on-chip meter bar to eliminate the need for separate calibration, eliminating the need for manual pipetting by the integration of on-chip pumps, and changing the manual glass etching process to computer-guided laser-based production. 2. Adding more data on PtNP conjugation to prove the technical feasibility. 3. Changing the contact PI to Dr. Ping Wang as the focus of the proposal shifts to clinical validation and end-user pilot testing. We will assess clinical sensitivity, clinical specificity, intra- and inter-user variability in a clinical environment (Hospital of University of Pennsylvania) with targeted end-users. These changes should demonstrate the clinical value and robustness of our device. Current non-invasive (or minimal-invasive) point-of-care (POC) platforms to assist the therapeutics for Substance Use Disorder (SUD) are facing challenges of non-quantitation, inaccuracy, non-compatible with diverse biological specimens, long assay time, and requirement for sophisticated instrument and/or expertise for readout. Here, we propose an Integrated Competitive Multiplexed Volumetric Bar Chart Chip (ICV- Chip) to assay drug targets in urine, whole blood, and saliva. The ICV-Chip platform is quantitative, sensitive, accurate, fast, portable, convenient and low cost. The ICV-Chip bioassay is non/minimally invasive and able to assess the patients' adherence to their medical treatment by the integration of an adherence marker Acetazolamide. The development of the ICV-Chip thus overcomes most of the current technology limits and opens up the possibility of instrument-free personalized assessment of drug abuse.

摘要 重新提交：开发用于药物定量的床旁体积条形图芯片 本提案是R 01（DA 035868 -01）三年期更新的重新提交。期间 在上一个资助期内，我们发表了40篇同行评审论文，申请了4项专利，其中17项 出版物和2项专利直接来自该赠款奖的支持。我们还有很多 原始数据和4个待出版物从这个赠款。授权书中的原始专利， 体积条形图芯片（V-Chip）专利，于2015年正式发布（US 9097710 B2）， 授权给埃塔医疗和奥瓦根我们的实验室芯片系统也是2015年研发100强的赢家 奖 在重新提交时，我们专注于进一步发展定量能力和点- 用于药物定量的V-Chip平台的护理前用户友好性。关键创新和 为回应检讨者的关注，我们作出的修订包括：的改进设计 V型芯片，使该设备在护理点的定量和用户友好更强大 设置.这包括修改片上仪表条，以消除对单独 校准，通过集成片上泵消除手动移液的需要，以及 将手工玻璃蚀刻工艺改为计算机引导的基于激光的生产。2.添加 关于PtNP缀合的更多数据以证明技术可行性。3.将联系人PI更改为 博士王平作为该提案的重点转移到临床验证和最终用户试点测试。 我们将评估临床敏感性、临床特异性、用户内和用户间变异性， 环境（宾夕法尼亚大学医院）与目标最终用户。这些变化 应证明我们器械的临床价值和耐用性。 目前的无创（或微创）床旁（POC）平台，以协助 物质使用障碍（SUD）的治疗面临着非定量的挑战， 不准确，与各种生物样本不兼容，测定时间长，以及 需要精密仪器和/或读出专业知识。 在这里，我们提出了一个集成的竞争性多路复用体积条形图芯片（ICV- 芯片）来分析尿液、全血和唾液中的药物靶标。ICV-Chip平台 定量、灵敏、准确、快速、便携、方便、成本低。ICV-Chip生物测定 是非/微创的，并且能够评估患者对药物治疗的依从性 通过整合粘附标记物乙酰唑胺。因此，ICV芯片的开发 克服了当前大多数技术限制，并开辟了无仪器的可能性。 药物滥用的个性化评估。