Integrated Microfluidic System for Oral Diagnostics

描述（申请人提供）：唾液和其他口腔液的分析在诊断口腔和全身疾病、监测环境毒素和滥用药物的水平以及初步筛查接触生物和化学战剂方面具有很大的潜力，在许多应用中，使用唾液和其他口腔流体作为诊断样品可能比其他体液更优选，这是因为唾液和其他口腔流体具有检测和分析的能力。在临床和非临床环境中快速和廉价的采样。尽管临床研究已经证明唾液和其他口腔流体在用于检测口腔和全身性疾病的标志物的一些应用中是有用的，但是诊断技术和设备的发展还没有达到预期。此外，目前的测定技术是耗时的，需要相对大量的样品，并且不适合自动化和便携性。本申请的目的如下：1）开发用于同时检测唾液和其他口腔流体中的多分析物的集成微流体系统。该原型将能够对微小样品体积进行快速和灵敏的分析，并将通过执行多路复用分析来获得更高的选择性; 2）分析在口腔流体中发现的口腔和牙周疾病的介质（即，牙龈卟啉单胞菌内毒素、白细胞介素和骨分解碎片）;以及3）在牙周病发展的低风险和高风险患者的纵向人体试验中验证该技术。这些目标的成功应提供技术转让和利用该设备在临床牙周病学以及潜在的应用，在初步筛选全身性疾病和接触生物战剂。

DESCRIPTION (provided by applicant): Analysis of saliva and other oral fluids has great potential in diagnosis of oral and systemic diseases, in monitoring levels of environmental toxins and drugs-of-abuse, and in preliminary screening for exposure to biological and chemical warfare reagents, The use of saliva and other oral fluids as diagnostic samples may be preferred in many applications over other bodily fluids because of the ability for fast and inexpensive sampling in clinical as well as non-clinical settings. Although, clinical studies have demonstrated usefulness of saliva and other oral fluids in some applications for detection of markers of oral and systemic diseases, the development of diagnostic technology and devices has not met the expectations. Moreover, the current assay techniques are time-consuming, require relatively large amounts of samples and are not amenable to automation and portability. The objectives of this application are the following: 1) Development of an integrated microfluidic system for simultaneous multi-analyte detection in saliva and other oral fluids. The prototype will be capable of rapid and sensitive analysis of minute sample volumes and will attain higher selectivity by performing multiplexed analysis; 2) Analysis of mediators of oral and periodontal diseases found in oral fluids (i.e., P. gingivalis endotoxin, interleukins, and bone breakdown fragments) using the proposed bench scale prototype; and 3) Validation of the technology in a longitudinal human trial of patients at low and high risk for the development of periodontal diseases. Success of these objectives should provide for technology transfer and utilization of this device in clinical periodontology as well as potential applications in preliminary screening for systemic diseases and exposure to biological warfare agents.