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，供该领域受过最低限度培训的人员使用，用于使用唾液作为样本样本诊断肺部疾病。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。该设备将是完全集成和独立的。唾液样本将装载到一次性微流控卡上，其中包含所有必要的成分和试剂，以处理样品并使用光纤微阵列测量多种临床相关分析物。结果将以光学方式读取，并通过液晶显示器和无线网络报告。肺部疾病将包括哮喘、慢性阻塞性肺疾病(COPD)/肺气肿、囊性纤维化和急性肺炎。将使用各种基于荧光的测定法获取和分析患病和对照患者的唾液样本。初始阶段将在门诊环境中进行，在患者病情稳定和病情加重期间，将定期对患者进行随访。将在基线和临床不稳定条件下收集和分析样本，以便分析基线的变化以及单样本与临床状态的相关性。为了直接验证唾液含有与疾病相关物质的整体假设，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结果进行比较。与疾病相关的分析物将被选择并转换成基于头部的传感器，用于光纤微阵列。要检查的分析物将包括DNA/RNA，蛋白质，如细胞因子，小分子和离子。所有样品制备和预处理将纳入微流控盒。一次性卡带将与传感器阵列集成，使许多临床参数能够同时测量。该阵列将由一个便携式光学读取器进行查询，该读取器将与微流体盒和光纤阵列设计并集成在一起。我们将在实验台上演示该系统的有效性，然后向临床研究人员提供一个Alpha和三个Beta单元，用于试点研究和扩展的现场试验。

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.