Rapid parallel salivary immunoassays on a disposable

描述（由申请人提供）：从被采样人的角度来看，唾液采集远优于血液采集。然而，近年来，用于测量血液中分析物的微流体技术发展迅速，而唾液作为分析物的使用在测量的分析物的数量和进行这种测量的环境方面都滞后。在某种程度上，这是因为唾液比血浆更易变，具有较低浓度的分析物，并且含有粘性和粘附性粘蛋白。如果可以使用唾液来测量血液中的许多分析物，并且可以一次对几种分析物进行测量，成本低廉，并且不需要技术培训，那么用于研究，治疗和健康维护的生物医学测试的质量，频率和范围将有可能得到巨大的改善，特别是对于门诊患者。该项目将开发一种集成的微流体系统，用于快速，廉价，同时测量唾液中的多种分析物，并采用简单的一次性聚合物层压材料形式。将开发一种微流体装置，以允许从唾液中的粘蛋白中快速提取分析物。两种新的但已被证明的免疫测定技术将与微流体系统相结合，该系统允许在环境条件下干燥储存所有试剂，并并行测量多种分析物。这些分析可以测量低水平的激素，药物，代谢物，甚至蛋白质，表明疾病的存在，以及特定于口腔的化合物，如病原体和口腔癌的标志物。免疫测定法最初将在商业免疫测定法可用的激素上进行验证。正在进行的平行扩散免疫测定的开发工作将通过与粘蛋白提取系统的耦合扩展到唾液检测。为了测量浓度低于扩散免疫测定检测限的分析物，将使用化学放大表面等离子体共振成像。将采用干试剂的溶解来用多个捕获分子装饰金表面。最后，将设计和测试一个多功能的组合系统，该系统将允许同时通过两种方法监测样品。

DESCRIPTION (provided by applicant): The collection of saliva is far preferable to collection of blood from the point of view of the person being sampled. However, in recent years microfluidic technologies for measuring analytes in blood have advanced rapidly, while the use of saliva as an analyte has lagged, both in terms of the number of analytes measured and the environments in which such measurements are made. In part, this is because saliva is more variable than plasma, has analytes in lower concentrations, and contains viscous and adhesive mucins. If it were practical to use saliva for many analytes commonly measured in blood, and to make those measurements on several analytes at once, inexpensively, and in a way not requiring technical training, enormous improvements in the quality, frequency and scope of biomedical testing for research, therapy, and health maintenance would be possible, particularly for ambulatory outpatients. This project will develop an integrated microfluidic system for rapidly, inexpensively, and simultaneously measuring multiple analytes in saliva, and in a simple disposable polymeric laminate format. A microfluidic device to allow rapid extraction of analytes from the mucins in saliva will be developed. Two new but demonstrated immunoassay technologies will be coupled to a microfluidic system that allows dry storage of all reagents at ambient conditions and measures multiple analytes in parallel. These assays can measure low levels of hormones, drugs, metabolites, and even proteins that indicate the presence of disease, as well as compounds specific to the oral cavity such as pathogens and markers for oral cancer. The immunoassays will initially be validated on hormones for which commercial immunoassays are available. Ongoing work on development of parallel diffusion immunoassays will be extended to saliva testing through coupling with the mucin-extraction system. To measure analytes present at concentrations below the limit of detection of the diffusion immunoassay, chemically amplified surface plasmon resonance imaging will be used. Dissolution of dry reagent will be employed to decorate the gold surface with multiple capture molecules. Finally, a versatile combined system will be designed and tested that will allow monitoring of samples by the two methods simultaneously.