Microsensor Arrays for Saliva Diagnostics

用于唾液诊断的微传感器阵列

• 批准号: 7282485
• 负责人: DAVID R. WALT
• 金额: $ 173.68万
• 依托单位: TUFTS UNIVERSITY MEDFORD
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-01 至 2011-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7282485
• 关键词: Academic Medical Centers; Accident and Emergency department; Acute; Acute Pneumonia; Ambulatory Care Facilities; Biological Assay; Boston; Chronic Obstructive Airway Disease; Chronic Obstructive Asthma; Clinic; Clinical; Clinical Investigator; Clinical Research; Collection; Complex; Condition; Cystic Fibrosis; Data; Devices; Diagnosis; Diagnostic; Disease; Documentation; Electronics; Film; Goals; Human Resources; Ions; Laboratories; Lead; Light; Liquid substance; Lung; Lung diseases; Measures; Microfluidic Microchips; Microfluidics; Numbers; Operative Surgical Procedures; Optical Readers; Optics; Outcome; Partner in relationship; Patients; Pennsylvania; Performance; Personal Satisfaction; Phase; Pilot Projects; Polymerase; Polymerase Chain Reaction; Positioning Attribute; Preparation; Process; Proteins; Pulmonary Emphysema; RNA-Directed DNA Polymerase; Reader; Reading; Reagent; Reporting; Research Personnel; Sales; Saliva; Salivary; Sampling; Solutions; Source; Specimen; Staging; System; Testing; Therapeutic; Training; Universities; Wireless Technology; base; clinically relevant; cytokine; design; design and construction; field study; liquid crystal; optical fiber; oral biology; programs; prototype; respiratory; saliva diagnostic; sensor; small molecule

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.

描述（由申请人提供）：本申请旨在开发一种便携式诊断系统，该系统可由本领域受过最低限度训练的人员使用，用于使用唾液作为样本来诊断肺部疾病。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。该装置将是完全一体化和独立的。将唾液样本加载到一次性微流控卡上，该微流控卡包含所有必要的组分和试剂，以处理样本并使用光纤微阵列测量多种临床相关分析物。结果将通过液晶显示器和无线网络进行光学读取和报告。将针对肺部疾病，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。将获得来自患病患者和对照患者的唾液样本，并使用各种基于荧光的测定进行分析。初始阶段将在门诊诊所环境中进行，当患者病情稳定时和疾病加重期间，将定期对患者进行随访。将在基线和临床不稳定状态下采集并分析样本，以便分析较基线的变化以及单样本与临床状态的相关性。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）以及小分子和离子。所有样品制备和预处理将被并入微流体盒中。一次性卡匣将与传感器阵列集成，从而能够同时测量许多临床参数。该阵列将由便携式光学读取器询问，该便携式光学读取器将被设计并与微流体盒和光纤阵列集成。我们将在实验室工作台上证明该系统的有效性，并随后向临床研究人员提供一个Alpha和三个Beta单元，用于试点研究和扩大的现场试验。