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潜力。在许多应用中，使用唾液和其他口腔液作为诊断样本可能比其他体液更受欢迎，因为在临床和非临床环境中能够快速和廉价地进行采样。虽然临床研究已经证明唾液和其他口腔液在检测口腔和全身疾病的标志物方面是有用的，但诊断技术和设备的发展并没有达到预期的效果。此外，目前的检测技术耗时长，需要相对大量的样品，不利于自动化和便携性。本应用的目标如下：1)开发一种集成的微流控系统，用于同时检测唾液和其他口服液中的多个分析物。该原型将能够对微量样本进行快速和灵敏的分析，并将通过执行多路分析获得更高的选择性；2)使用拟议的台架规模原型分析口腔和牙周疾病的介质(即牙龈假单胞菌内毒素、白细胞介素素和骨破裂碎片)；以及3)在牙周病低风险和高风险患者的纵向人体试验中验证该技术。这些目标的成功应有助于在临床牙周学中转让和利用这一装置，以及在系统性疾病的初步筛查和接触生物战剂方面的潜在应用。

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.