Microsensor Arrays for Saliva Diagnostics

本申请旨在开发一种便携式诊断系统，该系统可由受过最低限度培训的人员使用， 使用唾液作为样本来诊断肺部疾病的领域。的最终目标 该项目旨在创建一个通用平台，用于使用唾液进行系统诊断。该设备将 完全集成和独立。将唾液样本加载到一次性微流体卡上 含有所有必要的成分和试剂，以处理样品并在临床上测量多种 相关的分析物与光纤微阵列。结果将通过光学方式读取，并通过 液晶显示器和无线网络。包括哮喘在内的肺部疾病将成为目标， 慢性阻塞性肺病（COPD）/肺气肿、囊性纤维化和急性肺炎。 将获得来自患病患者和对照患者的唾液样品，并使用多种免疫组织化学方法进行分析。 基于荧光的测定。初始阶段将在门诊诊所进行，患者 在病情稳定时和疾病加重期间定期随访。样品将 在基线和临床不稳定条件下收集并分析，以分析 基线以及单样本与临床状态的相关性。直接测试我们的假设， 唾液中含有与疾病相关物质，我们还将收集和分析主要代表性的 呼吸道分泌物，并将这些结果与唾液分析结果进行比较。的分析物 将选择与疾病相关的传感器，并将其转换为基于珠子的传感器，用于光纤 微阵列待检查的分析物将包括DNA/RNA、蛋白质如细胞因子和小分子蛋白质。 分子和离子。所有样品制备和预处理将被并入微流体分析仪中。 盒式磁带。一次性卡匣将与传感器阵列集成，可实现许多临床参数 同时测量。该阵列将由便携式光学读取器询问， 设计并与微流体盒和光纤阵列集成。我们将演示 系统在实验室工作台上的有效性，随后向临床提供一个Alpha和三个Beta单位 研究人员进行试点研究和扩大实地试验。

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 subtances 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.