Compact Liquid Chromatography for Routine Screening in Drug Treatment Centers

用于戒毒中心常规筛查的紧凑型液相色谱

• 批准号: 10599765
• 负责人: MILTON L. LEE
• 金额: $ 25.86万
• 依托单位: AXCEND, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10599765
• 关键词: Academia; Algorithmic Software; Algorithms; Area; Barbiturates; Benchmarking; Benzodiazepines; Biological Assay; Blood capillaries; Body Fluids; Caring; Cells; Characteristics; Chemicals; Chromatography; Collaborations; Column Chromatography; Complex; Coupled; Coupling; Detection; Development; Devices; Disease; Drug Monitoring; Drug Rehabilitation Centers; Drug Screening; Drug Targeting; Ensure; Environment; Equipment; Gas Chromatography; Gold; Guidelines; Healthcare; Illicit Drugs; Immunoassay; Individual; Liquid Chromatography; Liquid substance; Mass Fragmentography; Mass Spectrum Analysis; Methodology; Methods; Monitor; Pain Clinics; Paper; Patient Care; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Preparation; Professional Practice; Protocols documentation; Research; Resolution; Risk; Sampling; Scientist; Sensitivity and Specificity; Small Business Innovation Research Grant; Solid; Solvents; Specificity; Substance Abuse Detection; Substance Use Disorder; Substance abuse problem; System; Technical Expertise; Techniques; Technology; Test Result; Testing; Therapeutic; Time; United States Substance Abuse and Mental Health Services Administration; Urine; absorption; aqueous; base; capillary liquid chromatography; computerized data processing; cost; data archive; data handling; design; detection limit; detection sensitivity; detector; drug of abuse; drug testing; illicit drug use; improved; innovation; instrument; interest; liquid chromatography mass spectrometry; novel; novel strategies; operation; point of care; point of care testing; routine screening; screening; substance abuse treatment; tandem mass spectrometry

Project Summary The Substance Abuse and Mental Health Services Administration (SAMHSA) has set guidelines for illicit drug monitoring for both screening and confirmatory tests. Point-of-care (POC) screening assays usually rely upon immunoassays that lack specificity among compounds in a given drug class. Confirmation testing usually employs chromatography coupled to mass spectrometry (MS), which is a powerful technique capable of identifying the relevant analytes of interest in complex samples; however, this approach requires large, expensive equipment that requires technical expertise to operate, thus precluding it from POC environments. In this Fast-Track SBIR project, scientists at Axcend Corporation in collaboration with chromatography and drug analysis experts in academia and advice from practicing health care professionals will pursue further development of a compact capillary liquid chromatography (LC) platform for rapid POC screening of drugs of abuse. In Phase I, sample preparation with a novel solid phase extraction (SPE) apparatus will be optimized and automated, a longer pathlength UV absorption detector flow cell will be created, and capillary LC stationary phases and mobile phases will be investigated and selected to achieve SAMHSA testing concentration cutoff limits for relevant compounds using the compact LC system. In Phase II, novel column-column and column- detector combinations, diode-array detection modules, and data processing approaches combining chromatographic retention times and UV absorption ratios will be developed to enhance the analysis of these compounds and provide timely information to support urgent patient treatment decisions. Key aspects of this proposal that are unique to advancing the field of POC chemical analysis using capillary LC are (1) improved sensitivity using novel simple off-line and on-line extraction and concentration devices, and a longer pathlength UV-absorption flow cell; (2) combinations of columns, solvents, and modes of operation for maximum LC separation, and (3) enhanced selectivity of detection using innovative tandem column–UV-detector combinations, (4) a new compact DAD UV-absorption detector for capillary LC, and (5) unique data handling software algorithms for peak deconvolution. These innovations are new to the area of POC analysis as well as to the broad field of capillary LC in general. The results from this project will be a critical step towards the release of a POC drug screening solution that provides improved patient care compared to current healthcare practices.

项目摘要 药物滥用和心理健康服务管理局（SAMHSA）已设定非法药物指南 监视筛查和确认测试。护理点（POC）筛选通常依赖 给定药物类别中化合物缺乏特异性的免疫测定。通常进行确认测试 采用色谱法连接到质谱（MS），这是一种强大的技术 确定复杂样本中感兴趣的相关分析物；但是，这种方法需要很大， 昂贵的设备需要技术专业知识才能运行，从而从POC环境中排除了它。在 这个快速轨道SBIR项目，Axcend Corporation的科学家与色谱和药物合作 学术界的分析专家和实践保健专业人员的建议将进一步追求 用于快速POC筛查药物的紧凑型毛细管液相色谱（LC）平台的开发 虐待。在第一阶段，将优化使用新型固相提取（SPE）设备的样品制备，并 将创建自动化的，更长的路径长度吸收检测器流动池，毛细管LC静止 将研究并选择阶段和移动阶段，以实现SAMHSA测试浓度截止 使用紧凑型LC系统的相关化合物的限制。在第二阶段，新颖的柱和柱 - 检测器组合，二极管阵列检测模块和数据处理方法结合 将开发色谱保留时间和紫外线吸收比以增强对这些的分析 化合物并提供及时的信息，以支持紧急患者治疗决策。关键方面 使用毛细血管LC推进POC化学分析领域所独有的建议是（1）改进 使用新颖的简单离线和在线提取和浓度设备以及更长的路径长度的灵敏度 紫外吸收流动池； （2）最大LC的列，解决方案和操作模式的组合 分离，（3）使用创新的串联柱 - UV检测器提高检测的选择性 组合，（4）毛细管LC的新型紧凑型爸爸吸收检测器和（5）独特的数据处理 峰值卷积的软件算法。这些创新是POC分析领域以及 一般来说，毛细管LC的广阔领域。该项目的结果将是迈出发布的关键一步 与当前的医疗保健实践相比，POC药物筛查解决方案可改善患者护理。