Integrated Microfluidic System for Oral Diagnostics

描述（由申请人提供）：唾液和其他口服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水平以及初步筛选生物和化学战试剂暴露方面具有巨大潜力。在许多应用中，使用唾液和其他口服液作为诊断样本可能优于其他体液，因为在临床和非临床环境中能够快速和廉价地取样。虽然临床研究已经证明了唾液和其他口腔液体在检测口腔和全身性疾病标志物的某些应用中的有用性，但诊断技术和设备的发展并未达到预期。此外，目前的分析技术耗时，需要相对大量的样品，不适合自动化和便携性。本应用程序的目标如下：1)开发一个集成的微流体系统，用于同时检测唾液和其他口腔液体中的多种分析物。该原型将能够快速和灵敏地分析微小的样品体积，并将通过执行多路分析获得更高的选择性；2)使用提出的实验规模原型分析口腔液中发现的口腔和牙周病介质（即牙龈卟啉卟啉菌内毒素、白细胞介素和骨分解碎片）；3)在牙周病发展低风险和高风险患者的纵向人体试验中验证该技术。这些目标的成功应该为临床牙周病中的技术转让和该装置的利用以及在系统疾病和暴露于生物战剂的初步筛选中的潜在应用提供条件。

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.