Non-Invasive Clinical Testing Using Biosensors

描述（由申请人提供）：非侵入性临床诊断的发展是改善医疗保健的重要目标。越来越多的人意识到，设计用于测试唾液和尿液的特定诊断可能与许多疾病和病症的常规血液测试一样具有预测性。理想情况下，未来对唾液和尿液的检测将是快速、定量的，并能够在适当的时候进行连续监测。生物传感器仪器加上新的诊断分析提供了很大的希望，在这一领域提供了解决几个技术问题的进展。BioHesion，Inc.将在拟议的可行性研究中使用专有协议，以实现以下目标： 1)开发使用表面等离子体共振检测来定量唾液和尿液中的总sIgA和白蛋白的诊断测试。测试在10- 15分钟内完成。身体分泌物中的总slgA测量将是在第II阶段中测量特定slgA的测试的要求。 2)当测试唾液和尿液时，生物传感器污染显著减少。 3)生物传感测定的灵敏度增加至少10倍。 4)提高生物传感表面的耐用性，以允许重复使用或连续监测患者。 这些目标的成功实现将促进移动的仪器能够在测试点进行定量、非侵入性诊断。最终，随着传感器小型化趋势的继续，该项目中开发的强大检测将与能够连续体内监测患者的微型传感器集成。

DESCRIPTION (provided by applicant): The development of non-invasive clinical diagnostics is a significant goal for improving healthcare. There is increasing awareness that specific diagnostics designed to test saliva and urine may be as predictive as conventional blood tests for many diseases and disorders. Ideally, future testing of saliva and urine will be rapid, quantitative and capable of continuous monitoring when appropriate. Biosensor instrumentation coupled with novel diagnostic assays offers great promise in this area provided there is progress in addressing several technical problems. BioHesion, Inc. will use proprietary protocols in the proposed feasibility research to achieve the following goals: 1) Development of diagnostic tests to quantify total slgA and albumin in saliva and urine using surface plasmon resonance detection. Testing is completed in 10-15min. Total slgA measurements in body secretions will be a requirement for tests to measure specific slgA in Phase II. 2) A significant reduction in biosensor fouling when testing saliva and urine. 3) An increase in the sensitivity of biosensing assays of at least 10-fold. 4) Increased durability of biosensing surfaces to permit repeated use or continuous monitoring of patients. The successful achievement of these goals will facilitate the implementation of mobile instruments capable of quantitative, non-invasive diagnostics at point-of testing. Ultimately, as the trend in sensor miniaturization continues, the robust assays developed in this project will be integrated with tiny sensors capable of continuous in vivo monitoring of patients.