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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要药物滥用和心理健康服务管理局 (SAMHSA) 制定了非法药物指南筛查和验证性检测的监测通常依赖于即时检测 (POC) 筛查测定。给定药物类别中的化合物之间通常缺乏特异性的免疫测定法。采用色谱法与质谱法 (MS) 联用，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操作，因此将其排除在 POC 环境之外。在这个 Fast-Track SBIR 项目中，Axcend Corporation 的科学家与色谱和药物合作学术界的分析专家和执业医疗保健专业人员的建议将进一步追求开发紧凑型毛细管液相色谱 (LC) 平台，用于快速 POC 筛选药物在第一阶段，将优化和利用新型固相萃取 (SPE) 装置进行样品制备。自动化，将创建更长光程的紫外吸收检测器流通池，并且毛细管 LC 固定将研究和选择固定相和流动相，以实现 SAMHSA 测试浓度截止值使用紧凑型液相色谱系统对相关化合物进行限制在第二阶段，新型柱-柱和柱-。探测器组合、二极管阵列探测模块和数据处理方法相结合将开发色谱保留时间和紫外吸收比以增强这些物质的分析化合物并提供及时的信息来支持紧急的患者治疗决策。推进使用毛细管液相色谱进行 POC 化学分析领域的独特提案是 (1) 改进使用新型简单的离线和在线提取和浓缩设备以及更长的光程来提高灵敏度紫外吸收流通池；(2) 色谱柱、溶剂和操作模式的组合，以实现最大 LC (3) 使用创新的串联柱-紫外检测器增强检测的选择性组合，(4) 用于毛细管 LC 的新型紧凑型 DAD 紫外吸收检测器，以及 (5) 独特的数据处理这些创新对于 POC 分析和 POC 领域来说都是新的。该项目的结果将是迈向毛细管液相色谱广泛领域的关键一步。与当前的医疗保健实践相比，POC 药物筛选解决方案可提供更好的患者护理。