Exhaled breath drug detection using differential mobility spectrometry

项目摘要 这一拟议的第一阶段/第二阶段FastTrack STTR项目旨在演示 能够检测和定量测量毒品(即大麻素和类阿片)的呼气测定仪 呼气(EB)。利用高效液相色谱检测EB中这些药物的前期工作 质谱学(LC/MS)表明这些化合物可以定量检测，而LC/MS是 实施速度慢、成本高，需要高技能人员才能实施。所需要的是一种简单而廉价的 EB中药物含量的快速测定方法。如果这样的方法可用，则可以由 执法部门以及医生办公室、医院急诊室、救护车和寻求 对员工进行药物滥用检查。 N2Biomedical建议开发一种通过以下方式定量检测EB中药物存在的方法 德雷珀实验室开发的差示迁移率光谱分析(DMS)。DMS是一个强大、数据丰富、超 痕量化学检测技术，已被证明可用于多种应用，包括空气质量机舱 对国际空间站的监测、化学战剂探测、爆炸物探测以及 饮用水分析。最近，Draper将这种设备应用于呼吸分析，以检测肺部 疾病。一项临床研究目前正在进行中，初步结果令人振奋。这个项目涉及到转移 Draper开发的肺部感染检测技术到呼气中精神活性药物的检测 呼吸。 拟议方案的第一阶段将在实验室调查大麻素的DMS签名，并确定 DMS设备的检测极限。还将进行一项小规模的试点研究，以证明使用 呼气分析作为血液中大麻素浓度的替代。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，并将进行一项50人的临床试验 获得THC(大麻素)、吗啡和芬太尼的呼吸/血液浓度相关性以及水平 造成损害的。将根据从以下方面获得的反馈，实施将该设备推向市场的计划 在整个计划过程中获得的当地执法部门和FDA的监管战略将是 已确认身份。该项目的成功完成将证明该DMS设备可以用作快速、 非侵入性广谱毒品检测工具，适用于执法人员和急救医务人员。

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.