All-in-one Device for Forensic Toxicology Drug Screening

用于法医毒理学药物筛选的一体化设备

• 批准号: 10482653
• 负责人: Justin Michael Wiseman
• 金额: $ 25.88万
• 依托单位: WIK DEVICES, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10482653
• 关键词: Antibodies; Automation; Autopsy; Blood; Blood Volume; Cessation of life; Chromatography; Clinical Laboratory Information Systems; Collection; Communities; Computer software; Consumption; Coroner; Data; Data Analyses; Detection; Development; Devices; Drops; Drug Screening; Drug Targeting; Effectiveness; Fentanyl; Forensic Medicine; Goals; Gold; Hand; High Pressure Liquid Chromatography; Immunoassay; Investigation; Laboratories; Manuals; Mass Fragmentography; Mass Spectrum Analysis; Medical Examiners; Methods; National Institute of Drug Abuse; Opioid; Outcome; Overdose; Paper; Paper Chromatography; Performance; Pharmaceutical Preparations; Phase; Plasma; Preparation; Procedures; Public Health; Reaction; Research Support; Resolution; Running; Sampling; Scanning; Sensitivity and Specificity; Solid; Solvents; Source; Standardization; Structure; Surveys; System; Techniques; Technology; Testing; Time; Toxic effect; Toxicology; United States National Institutes of Health; Whole Blood; addiction; alpha-SNAP; analog; base; commercialization; cost; design; detection limit; flexibility; improved; instrument; instrumentation; ion source; ionization; liquid chromatography mass spectrometry; mass spectrometer; novel; overdose death; performance tests; prototype; research and development; sample collection; screening; software development; synthetic cannabinoid; synthetic drug; virtual; wasting

Project Summary/Abstract Drug screening in toxicology cases is performed mainly using immunoassays, gas- chromatography mass spectrometry (GC-MS), and liquid chromatography-mass spectrometry (LC-MS). Immunoassays lack the sensitivity, multiplexing capability, and flexibility to respond to the rise of potent synthetic drugs including fentanyl analogs and synthetic cannabinoids. GC- MS requires extensive sample preparation including derivatization reactions to achieve adequate performance. LC-MS, despite being a mature technology, is still not used by most labs for drug screening due to is high cost and complexity. We therefore see a both a technical and market need for better drug screening technologies that combine the simplicity and automation of immunoassays with the high sensitivity and specificity of mass spectrometry. In this Fast-Track (combined phase I and phase II) proposal, we seek to develop a mass spectrometry-based drug screening system utilizing paper spray mass spectrometry. The outcomes of this project will include two disposable cartridge devices which perform sample collection, storage, extraction, and ionization for MS detection. In addition to the disposable devices, we will also develop a simple manually operated and a second automated mass spectrometer interface which will enable analysis of the sample analysis cartridge on commercially available mass spectrometers. Finally, we will create instrument control and data analysis software package to provide a complete, end- to-end solution for drug screening. In phase I of this proposal, a prototype for the disposable paper spray analysis cartridge as well as the manual mass spectrometry interface will be developed and tested. If the performance of the analysis cartridge and interface are adequate for screening a representative set of synthetic drugs, we will proceed to phase II. In the second phase, we will improve the sample analysis cartridge, develop a sample collection device which will enable robust collection of a known volume of blood from an unspecified initial volume, develop the automated MS interface, develop needed control and data analysis software, and test the performance of the approach on both high resolution and low resolution mass spectrometers.

项目摘要/摘要 在毒理学病例中进行药物筛查主要是使用免疫测定，气体进行的 色谱质谱法（GC-MS）和液相色谱 - 质量光谱法 （LC-MS）。免疫测定缺乏灵敏度，多重能力和灵活性的响应 有效合成药物的兴起，包括芬太尼类似物和合成大麻素。 GC- MS需要广泛的样品制备，包括衍生反应以实现足够 表现。 LC-MS尽管是一项成熟的技术，但大多数实验室仍未用于药物 筛选是高成本和复杂性。因此，我们看到了技术和市场需求 为了更好地结合使用简单性和自动化的药物筛查技术 具有高灵敏度和质谱特异性的免疫测定。在此快速轨道中 （I阶段和第二阶段）提案，我们寻求开发基于质谱的药物 筛选系统利用纸喷雾质谱法。这个项目的结果将 包括两个一次性弹药设备，可执行样品收集，存储，提取， 和MS检测的电离。除了一次性设备外，我们还将开发一个 简单的手动操作和第二个自动质谱仪接口，将启用 在市售质谱仪上的样品分析弹药筒分析。最后， 我们将创建仪器控制和数据分析软件包，以提供完整的，最终的 用于药物筛查的末端解决方案。 在该提案的第一阶段，是一次性纸喷雾分析墨盒的原型 以及手动质谱界面以及测试。如果是 分析墨盒和界面的性能足以筛选代表 一组合成药物，我们将继续进行第二阶段。在第二阶段，我们将改进样本 分析弹药筒，开发样品收集设备，该设备将启用强大的收集 未指定初始体积的血液量，发展自动化的MS接口， 开发所需的控制和数据分析软件，并测试该方法的性能 高分辨率和低分辨率质谱仪。