Microsensor Arrays for Saliva Diagnostics

该应用程序旨在开发一种便携的诊断系统，可供受过最低限度培训的人员使用 以唾液为样本的肺部疾病诊断领域。的最终目标是 该项目是创建一个使用唾液进行系统诊断的通用平台。这个装置将会是 完全集成且自给自足。唾液样本将被加载到一次性微流体卡上 含有所有必要的成分和试剂来处理样本并在临床上测量多个 相关分析物与光纤微阵列。结果将以光学方式读取并通过 液晶显示器和无线网络。将针对包括哮喘在内的肺部疾病， 慢性阻塞性肺疾病(COPD)/肺气肿、囊性纤维化和急性肺炎。 来自疾病患者和对照患者的唾液样本将通过各种不同的 基于荧光的分析。初始阶段将在门诊环境中进行，在那里患者 在病情稳定和恶化期间，将定期对其进行跟踪。样品将会是 在基线和临床不稳定情况下收集和分析，允许分析从 基线和单一样本与临床状态的相关性。直接测试我们的总体假设 唾液中含有与疾病相关的物质，我们还将收集和分析关键代表 并将这些结果与唾液分析结果进行比较。分析物 与疾病相关的将被选择并转换为基于珠子的传感器，以与光纤一起使用 微阵列。要检查的分析对象将包括DNA/RNA、细胞因子等蛋白质和小分子 分子和离子。所有样品制备和前处理都将整合到微流控芯片中 卡带。一次性试剂盒将与传感器阵列集成在一起，实现许多临床参数 同时进行测量。该阵列将由便携式光学读取器进行询问，该读取器将 设计并集成了微流控芯片和光纤阵列。我们将演示 该系统在实验室的有效性，以及后来为临床提供一个阿尔法和三个贝塔单位 调查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.