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 药物滥用和精神卫生服务管理局(SAMHSA)为非法药物制定了指导方针 对筛查和确证试验进行监测。医疗点(POC)筛查分析通常依赖于 在特定药物类别的化合物中缺乏特异性的免疫分析。确认测试通常 采用色谱与质谱联用(MS)，这是一种强大的技术，能够 识别复杂样品中感兴趣的相关分析物；然而，这种方法需要大量的， 昂贵的设备需要技术专业知识才能运行，因此无法进入PoC环境。在……里面 在这个快速通道SBIR项目中，Axcend公司的科学家与层析和药物合作 学术界的分析专家和执业卫生保健专业人员的建议将进一步 高效毛细管液相色谱(LC)平台的建立及其用于药物的POC快速筛选 虐待。在第一阶段，将优化使用新型固相萃取(SPE)装置的样品制备，并 自动化，更长路径的紫外吸收检测器流动池将被创建，而毛细管LC固定 将调查和选择相和流动相，以实现SAMHSA检测浓度的截止 使用紧凑型LC系统的相关化合物的限量。在第二阶段，新型柱子-柱子和柱子- 检测器组合、二极管阵列检测模块和组合的数据处理方法 将开发色谱保留时间和紫外线吸收比，以加强对这些物质的分析 并提供及时的信息，以支持紧急患者的治疗决定。这方面的关键方面 改进了毛细管LC在POC化学分析领域的独到之处：(1) 使用新的简单的离线和在线提取和浓缩装置以及更长的路径长度来提高灵敏度 紫外光吸收流动池；(2)柱、溶剂和操作模式的组合，以获得最大LC 分离，以及(3)使用创新的串联柱-UV检测器提高检测的选择性 (4)用于毛细管LC的新型紧凑型DAD紫外吸收检测器，以及(5)独特的数据处理 峰值反卷积的软件算法。这些创新对于PoC分析领域以及 一般涉及毛细管LC的广阔领域。这个项目的结果将是朝着发布的关键一步 与当前的医疗实践相比，POC药物筛选解决方案提供了更好的患者护理。