Microsensor Arrays for Saliva Diagnostics

描述(由申请人提供)：本申请旨在开发一种便携式诊断系统，可供受过最低限度培训的现场人员使用，以唾液为样本诊断肺部疾病。该项目的最终目标是创建一个使用唾液进行系统诊断的通用平台。该设备将完全集成和自给自足。唾液样本将被装载到一张一次性微流控卡片上，其中包含所有必要的组件和试剂，以处理样本并使用光纤微阵列测量多个临床相关的分析物。结果将通过光学读取，并通过液晶显示器和无线网络报告。将针对包括哮喘、慢性阻塞性肺疾病(COPD)/肺气肿、囊性纤维化和急性肺炎在内的肺部疾病。疾病患者和对照患者的唾液样本将被获取，并使用各种基于荧光的分析方法进行分析。最初阶段将在门诊环境中进行，在患者病情稳定和恶化期间，将定期对患者进行跟踪。将在基线和临床不稳定条件下收集和分析样本，以便分析与基线的变化以及单个样本与临床状况的相关性。为了直接检验我们的总体假设，即唾液中含有与疾病相关的物质，我们还将收集和分析关键的代表性呼吸道分泌物，并将这些结果与唾液分析得到的结果进行比较。与疾病相关的分析物将被选择并转换为基于珠子的传感器，用于光纤微阵列。需要检查的分析对象将包括DNA/RNA、细胞因子等蛋白质以及小分子和离子。所有样品制备和前处理都将被合并到一个微流控盒式磁带中。一次性盒将与传感器阵列集成在一起，使许多临床参数能够同时测量。该阵列将由便携式光学读取器询问，该读取器将被设计并与微流体盒和光纤阵列集成在一起。我们将在实验室平台上展示该系统的有效性，稍后将向临床研究人员提供一个Alpha和三个Beta单元，用于试点研究和扩大现场试验。

DESCRIPTION (provided by applicant): This application aims to develop a portable, diagnostic system useable by minimally trained personnel in the field for the diagnosis of pulmonary diseases using saliva as a sample specimen. The ultimate goal of the project is to create a universal platform for performing systemic diagnosis using saliva. The device will be fully integrated and self-contained. A saliva specimen will be loaded onto a disposable microfluidic card containing all the necessary components and reagents to process the sample and measure multiple clinically relevant analytes with an optical fiber microarray. The results will be read optically and reported both via a liquid crystal display and over a wireless network. Pulmonary diseases will be targeted including asthma, chronic obstructive pulmonary disease (COPD)/emphysema, cystic fibrosis, and acute pneumonia. Saliva samples from both diseased and control patients will be obtained and analyzed using a variety of fluorescent-based assays. The initial phase will be carried out in an outpatient clinic setting, where patients will be followed at regular intervals when stable and during exacerbations of their disease. Samples will be collected and analyzed at baseline and during clinically unstable conditions allowing analysis of change from baseline as well as single sample correlations with clinical status. To directly test our overall hypothesis that saliva contains substances that correlate with disease, we will also collect and analyze key representative respiratory secretions and compare these results with those obtained from salivary analysis. Analytes that correlate with disease will be selected and converted into bead-based sensors for use with optical fiber microarrays. Analytes to be examined will include DNA/RNA, proteins such as cytokines, and small molecules and ions. All sample preparation and pre-treatments will be incorporated onto a microfluidic cassette. The disposable cassette will be integrated with the sensor array, enabling many clinical parameters to be measured simultaneously. The array will be interrogated by a portable optical reader that will be designed and integrated with the microfluidic cassette and the optical fiber array. We will demonstrate efficacy of the system at the lab bench and later provide one Alpha and three Beta units to the clinical investigators for pilot studies and expanded field trials.