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: 8563058
• 负责人: Lidong Qin
• 金额: $ 70.79万
• 依托单位: METHODIST HOSPITAL RESEARCH INSTITUTE
• 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 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8563058
• 关键词: Address; Adherence; Antibodies; Area; Bedside Testings; Biological Assay; Biological Markers; Biometry; Blood; Blood specimen; Clinic; Clinical; Clinical Trials; Communication; Complex; Computers; Data; Decision Making; Development; Diagnosis; Diagnostic; Disease Management; Drug Exposure; Drug Targeting; Drug abuse; Drug usage; Enzyme-Linked Immunosorbent Assay; Equipment; Frequencies; Gas Chromatography; Glass; Grant; Home environment; Hospitals; Human Chorionic Gonadotropin; Hydrogen Peroxide; Illicit Drugs; Image; Laboratories; Liquid Chromatography; Measurement; Measures; Medical; Medicine; Methods; Microfabrication; Microfluidics; Monitor; Nature; Outpatients; Oxygen; Pharmaceutical Preparations; Preclinical Drug Evaluation; Pregnancy; Production; Proteins; Reaction; Reader; Reading; Sampling; Self Assessment; Slide; Specimen; Spottings; Substance Abuse Detection; Substance Use Disorder; Techniques; Technology; Telemedicine; Testing; Therapeutic Clinical Trial; Time; Training; Triage; Uncertainty; Urine; Visit; Visual; Weight; addiction; assay development; base; catalase; clinical practice; computerized data processing; cost; drug testing; instrument; instrumentation; internal control; mass spectrometer; meetings; miniaturize; minimally invasive; new technology; operation; point of care; point-of-care diagnostics; portability; programs; public health relevance; research study; response; sample collection; screening

DESCRIPTION (provided by applicant): Current non-invasive (or minimally invasive) methods to assist outpatient clinical trials of therapeutics for Substance Use Disorders (SUD) are usually limited by issues such as 1) the inability to accurately and quantitatively monitor the frequency and level of a subject's illicit drug exposure and 2) uncertainty in assessing the level of a subject's adherence to the trial medication regiment. These limitations are mainly due to the technological challenges of (1) non-quantitative measurements, (2) inaccuracy, (3) requirement for frequent clinical visits, and (4) requirement for instrument and/or expertise for readout. Several available Point-of-Care (POC) ELISA platforms are able to screen drug usage qualitatively. However, the POC quantitative measurement remains an unmet, yet critical need in the assessment of drug abuse. Microfluidics has emerged as a potential approach for POC drug tests and personalized diagnostics, because of its potential capabilities for multiplexed and quantitative measurements, portability, low cost, high throughput, and other advantages. However, the full development of a platform that overcomes all the listed challenges has not yet been realized. Here, we propose a Multiplexed Volumetric Bar-Chart Chip (V-Chip) to assay for drug targets in diverse clinical samples, which integrates functions including quantitation, instrument free readout, portability, and affordability. Volumetric readouts, based on measurements of oxygen generated by a reaction between catalase and hydrogen peroxide, allow instant and visual quantitation of target drugs and biomarkers and generate visual bar charts without the need for external instruments, data processing, or graphic plotting. The development of the V-Chip thus marks a POC milestone and opens up the possibility of instrument-free personalized diagnosis and SUD management.

描述（由申请人提供）：目前用于辅助物质使用障碍（SUD）治疗的门诊临床试验的无创（或微创）方法通常受到以下问题的限制：1）无法准确和定量监测受试者非法药物暴露的频率和水平，2）评估受试者对试验药物方案的依从性水平的不确定性。这些限制主要是由于以下技术挑战：（1）非定量测量，（2）不准确，（3）需要频繁的临床访视，以及（4）需要仪器和/或专业知识进行读数。 几种可用的床旁（POC）ELISA平台能够定性筛选药物使用。然而，POC定量测量仍然是评估药物滥用方面的一个未得到满足的关键需求。微流控技术由于其多重和定量测量的潜在能力、便携性、低成本、高通量和其他优点，已成为POC药物测试和个性化诊断的潜在方法。 然而，一个能够克服所有列出的挑战的平台的全面开发尚未实现。 在这里，我们提出了一个多路复用的体积条形图芯片（V芯片），以测定药物靶点在不同的临床样品，它集成了功能，包括定量，仪器免费读出，便携性和负担得起的。基于过氧化氢酶和过氧化氢之间反应产生的氧气的测量值的体积读数允许对靶药物和生物标志物进行即时和可视化定量，并生成可视化条形图，而无需外部仪器、数据处理或图形绘制。因此，V-Chip的开发标志着POC的里程碑，并开辟了无仪器个性化诊断和SUD管理的可能性。