Exhaled breath drug detection using differential mobility spectrometry

项目摘要 该拟议的I/II期FastTrack STTR项目旨在证明 能够检测和定量测量药物（即大麻素和阿片类药物）的呼吸测醉仪 呼出气（EB）。通过液相色谱法检测EB中这些药物的先前工作， 质谱（LC/MS）表明，这些化合物可以定量检测，但LC/MS是 缓慢、昂贵并且需要高技能人员来实施。我们需要的是一种简单而廉价的 一种快速测定EB中药物含量的方法。如果有这样的方法，它可以用于 执法部门和医生办公室、医院急诊室、救护车和寻求 检查员工是否滥用药物 N2 Biomedical建议开发一种方法，通过以下方式定量检测EB中药物的存在： 差示迁移率光谱法（DMS）是在德雷珀实验室开发的。DMS是一个强大的、数据丰富的、超 痕量化学检测技术已被证明适用于包括空气质量舱在内的众多应用 国际空间站上的监测、化学战剂探测、爆炸物探测，以及 饮用水分析最近，德雷珀已将该装置应用于呼吸分析，以检测肺部 疾病目前正在进行临床研究，初步结果是有希望的。该项目涉及转移 由德雷珀开发的用于肺部感染检测的技术， 呼吸 拟议计划的第一阶段将在实验室中调查大麻素的DMS特征，并确定 DMS设备的检测极限还将进行一项小型试点研究，以证明使用 呼吸分析作为血液中大麻素浓度的代表。在第二阶段DMS签名期间 将对阿片类药物吗啡和芬太尼进行表征，并将进行50例受试者的临床试验， 获得THC（大麻素）、吗啡和芬太尼的呼吸/血液浓度相关性， 的损害。将根据以下方面的反馈实施将该器械推向市场的计划： 在整个项目过程中获得的当地执法部门和FDA监管策略将 鉴定该项目的成功完成将表明，该DMS设备可用作快速， 非侵入式广谱药物检测工具，适用于执法人员和急救医疗人员。

Project Summary This proposed Phase I/Phase II FastTrack STTR project is intended to lead to the demonstration of a breathalyzer instrument capable of detecting and quantitatively measuring drugs (i.e. cannabinoids and opioids) in exhaled breath (EB). Prior work on the detection of these drugs in EB by means of liquid chromatography and mass spectrometry (LC/MS) demonstrated that these compounds can be quantitatively detected, but LC/MS is slow, expensive and requires highly skilled personnel to implement. What is needed is a simple and inexpensive method for rapidly measuring the amount of drugs in EB. If such a method becomes available it can be used by law enforcement and in doctors' offices, hospital emergency rooms, ambulances and companies seeking to screen employees for drug abuse. N2 Biomedical proposes to develop a method for quantitatively detecting the presence of drugs in EB by means of Differential Mobility Spectrometry (DMS) developed at Draper Laboratories. DMS is a robust, data-rich, ultra- trace, chemical detection technology that has been proven for numerous applications including air quality cabin monitoring on the International Space Station, chemical warfare agent detection, explosives detection, and drinking water analysis. Recently Draper has applied this device to breath analysis for the detection of lung diseases. A clinical study is currently underway and initial results are promising. This project involves transferring technology developed by Draper for lung infection detection to the detection of psychoactive drugs in exhaled breath. Phase I of the proposed program will investigate the DMS signatures of cannabinoids in the laboratory and define the DMS device’s limits of detection. A small pilot study will also be performed to demonstrate feasibility for using breath analysis as a proxy for the concentration of cannabinoids in the blood. During Phase II DMS signatures of the opioids morphine and fentanyl will be characterized and a 50 subject clinical trial will be performed to obtain breath/blood concentration correlations for THC (cannabinoid), morphine and fentanyl and also to levels of impairment. A plan for bringing this device to market will be implemented based on feedback obtained from local law enforcement obtained throughout the course of the program and an FDA regulatory strategy will be identified. Successful completion of this project will demonstrate that this DMS device can be used as a rapid, non-invasive broad spectrum drug detection tool for law enforcement as well as emergency medical personnel.