Non-invasive Blood Alcohol Sensor for Emergency Room Applications

描述(由申请人提供)： 项目概述对急诊室滥用酒精和药物中毒的准确量化是进行准确诊断和迅速治疗的重要筛查步骤。在没有酒精和药物中毒筛查的情况下，一些严重的紧急情况，如创伤性头部损伤、糖尿病和中风，可能会被误诊；可靠地测量酒精和药物摄入量将改善这些病例的诊断和后续治疗。目前急诊室使用的大多数方法要么需要患者合作和互动，如呼气测定仪，要么是侵入性的，处理时间较长，如血液和尿样分析，使其不适合应用于急诊室。特别是，遭受药物和酒精中毒的患者往往不能或不愿意与医务人员互动，因此需要更容易的采样和可靠的测量。为了满足这一需求，智能光学系统公司正在与德克萨斯理工大学健康科学中心(TTUHSC)急诊医学部的Robert Woolard博士合作，为ER应用开发基于唾液的非侵入性分析仪。该分析仪测量荧光标记选择性试剂的排放量，以检测唾液样本中滥用酒精和药物的情况。虽然唾液监测是酒精和药物滥用的既定领域，但仍需要准确的定量测量来量化入院急诊室患者的中毒程度，而不依赖于视觉判断。在第一阶段，我们论证了对缓冲液和模拟唾液中的酒精水平以及Woolard博士和TTUHSC获得的30个人类唾液样本进行测试并与血液水平进行比较的可重复性、高灵敏度测量的可行性。在第二阶段，我们将测试另外100个人体样本，以扩大统计数据并确定传感器的准确性和精密度水平，介绍一种定量(高/中/低)测量六种滥用药物(鸦片类、可卡因、苯丙胺、THC、苯二氮卓类、巴比妥类)的方法，并开发便携式读数系统。目标是一种简单但高精度的光学检测平台，适用于床边ER应用，并具有在许多医疗保健环境中广泛应用的临床监测应用的进一步潜力。

DESCRIPTION (provided by applicant): Project Summary Accurate quantification of alcohol and drugs of abuse intoxication in emergency rooms (ERs) is an important screening step for a precise diagnosis and hence for prompt treatment. Some severe emergencies such as traumatic head injury, diabetes, and stroke can be misdiagnosed in the absence of screening for alcohol and drug intoxication; reliable measurement of alcohol and drug intake levels would improve diagnosis and subsequent treatment in these cases. Most methods now used in emergency rooms either require patient cooperation and interaction, such as a Breathalyzer, or are invasive and have prolonged processing times, such as blood and urine sample analysis, making them inappropriate for ER applications. In particular, patients suffering from drug and alcohol intoxication are often not able, or are unwilling, to interact with medical personnel, hence the need for easier sampling and reliable measurement. To address this need, Intelligent Optical Systems is collaborating with Dr. Robert Woolard of Texas Tech University Health Science Center (TTUHSC) Emergency Medicine Department, a recognized expert in alcohol and drugs of abuse in ER-related studies, in our development for a non-invasive saliva-based analyzer for ER applications. The analyzer measures emissions of fluorescent-labeled selective reagents to detect alcohol and drugs of abuse in saliva samples. Although saliva monitoring is an established area for alcohol and drugs of abuse, accurate quantitative measurements are still needed to quantify the intoxication levels in admitted ER patients without relying on visual judgments. In Phase I we demonstrated the feasibility of achieving reproducible, highly sensitive measurements of alcohol levels in buffer and modeled saliva, as well as in 30 human saliva samples obtained by Dr. Woolard and TTUHSC that were tested and compared to blood levels. In Phase II we will test an additional 100 human samples to expand the statistical data and determine sensor accuracy and precision levels, introduce a method for quantitative (high/mid/low) measurement of six drugs of abuse (opiates, cocaine, amphetamines, THC, benzodiazepines, barbiturates), and develop the portable readout system. The objective is a simple yet highly accurate optical detection platform suitable for bedside ER applications, with further potential for widespread clinical monitoring applications in many healthcare settings.