A Microfluidic Diffusion Immunoassay

申请人？S描述：最强大和最通用的生物医学之一 诊断工具，免疫测定，用于监测药物水平， 体液中的激素，诊断传染病和自身免疫性疾病， 诊断和监测癌症的治疗。免疫测定的性能 目前主要限于集中实验室，因为需要 分析时间长，设备复杂且昂贵， 专业人如果进行的7亿次免疫测定中 每年仅在美国就可以更便宜，更频繁地运行， 在护理方面，数百万病人的健康可以得到改善。 微流体技术的最新发展表明， 开发出能够像血液一样轻松进行免疫测定的技术 今天的血糖测试 微流体扩散免疫测定法（DIA）刚刚被证明可以 提供了一套新的生化过程和一个通用的分析平台 它们非常适合于这种小型化和简化的仪器。在 这种测定法，垂直于微通道中的流动的分子的运输 受抗原和抗体之间结合的影响。通过成像 标记组分在流动流中的稳态位置， 可以在几微升中测量非常稀释的分析物的浓度 采样时间为秒。该试验已在小型 使用荧光成像检测的分子分析物竞争免疫测定。 因此，DIA可以用于监测药物、激素和其他小的 分析物。建模表明，目前的测定可以很容易地检测分子 低于1-10 nM的范围内，它已被证明，并可以监测 分析物的浓度与蛋白质一样大，以增加测定为代价 次提出了一项为期4年的计划，通过一系列体外试验， 越来越复杂的样品，DIA的临床潜力。是 研究的是1）小的灵敏度和选择性的全范围 在血液和衍生的生物流体存在下的分子DIA，和2） DIA是否可以扩展到大分子分析物的检测， 尤其是蛋白质。

APPLICANT?S DESCRIPTION: One of the most powerful and versatile biomedical diagnostic tools, the immunoassay, is used to monitor the levels of drugs and hormones in body fluids, to diagnose infectious and autoimmune diseases, and to both diagnose and monitor treatment of cancer. The performance of immunoassays is today largely restricted to centralized laboratories because of the need for long assay times, complex and expensive equipment, and highly trained technicians. If a wider range of the 700 million immunoassays performed annually in the US alone could be run more inexpensively, more frequently, and at the point of care, the health of millions of patients could be improved. Recent developments in microfluidics suggest that instruments could soon be developed that would allow immunoassays to be performed as easily as is blood glucose testing today. A microfluidic diffusion immunoassay (DIA) has just been demonstrated that may provide a new set of biochemical processes and a common analytical platform that are well suited to such miniaturized and simplified instrumentation. In this assay, the transport of molecules perpendicular to flow in a microchannel is affected by binding between antigens and antibodies. By imaging the steady-state position of labeled components in a flowing stream, the concentration of very dilute analytes can be measured in a few microliters of sample in seconds. This assay has been demonstrated in the format of a small molecule analyte competition immunoassay using fluorescence imaging detection. The DIA could, then, be used for monitoring drugs, hormones, and other small analytes. Modeling suggests that the current assay can easily detect molecules below the 1-10 nM range in which it has been demonstrated, and could monitor concentrations of analytes as large as proteins, at the cost of increased assay times. Proposed is a 4-year plan to determine, by a series of in vitro tests on increasingly complex samples, the clinical potential of the DIA. To be investigated are 1) the full range of sensitivity and selectivity of the small molecule DIA in the presence of blood and derived biological fluids, and 2) whether the DIA can be extended to detection of large molecule analytes, particularly proteins.