A Microfluidic Diffusion Immunoassay

申请者？S描述：最强大和最多功能的生物医学之一 诊断工具，免疫分析，被用来监测药物和 体液中的激素，用于诊断传染病和自身免疫性疾病，以及 对癌症进行诊断和监测治疗。免疫分析的性能 今天主要局限于集中式实验室，因为需要 化验时间长，设备复杂昂贵，训练有素 技术人员。如果7亿次免疫分析中的更大范围 每年仅在美国就可以更便宜、更频繁地运营，而且 在护理方面，数百万患者的健康可以得到改善。 微流体学的最新发展表明，仪器可能很快就会 开发了一种可以像血液一样容易地进行免疫分析的技术 今天的血糖检测。 一种微流控扩散免疫分析(DIA)刚刚被证明可以 提供一套新的生化流程和通用分析平台 它们非常适合于这种小型化和简化的仪器。在……里面 这种分析是指分子在微通道中垂直流动的传输 受抗原和抗体结合的影响。通过想象 已标记组件在流动的流中的稳态位置， 极稀的分析物的浓度可以在几微升的 样品在几秒钟内就能完成。这个测试已经以一个小的形式进行了演示 采用荧光成像检测的分子分析物竞争免疫分析。 因此，DIA可以用于监测药物、激素和其他小分子物质 分析物。建模表明，目前的检测方法可以很容易地检测到分子 在已演示的1-10 NM范围内，并且可以监控 分析物的浓度与蛋白质一样大，代价是增加化验 泰晤士报。提出了一项为期4年的计划，通过一系列的体外试验来确定 随着样本的日益复杂，DIA的临床潜力越来越大。成为 考察的是1)小分子的全范围的灵敏度和选择性 在血液和衍生生物体液存在下的分子DIA，以及2) DIA能否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.