SBIR Phase I: Hydrodynamically Driven Immunoassays: An Approach to Real Time Biosensing

该奖项是根据2009年《美国复苏和再投资法案》(公法111-5)资助的。这个小型企业创新研究第一阶段项目致力于解决对低成本技术的需求，以显著减少完成诊断测试所需的时间，同时保持并可能提高分析和诊断的灵敏度。完成免疫分析所需的时间通常由基于扩散的抗原和标记的质量传输决定。蛋白质、病毒和许多其他大型疾病标志物固有的低扩散系数加剧了这种情况，这些测试和许多其他类型的测试可能需要数小时或数天才能完成。这项第一阶段的提案侧重于开发一种创新的流体力学方法，在与现有的护理点(POC)和临床器械兼容的框架内，通过自由液体喷射输送系统来增加反应物的通量。该方法基于以下假设：(1)质量传输是大多数基于分子识别的分析的限速步骤；(2)非特异性吸附的速度慢于特异性结合的速度。本项目探讨了使用喷雾喷射技术作为一种提高反应物流量的方法的优点，从而显著提高分析速度，同时可能降低非特异性吸附。这项研究的更广泛影响是使诊断转变为关注点。对预防性医疗保健的日益关注正在升级对快速PoC设备和高通量临床测试的需求。医疗保健提供者对患者的期望和健康测试的出现为新的POC设备和平台的诞生奠定了基础，这些设备和平台可以增加体外诊断行业的样本吞吐量。进一步扩大对尽可能接近实时检测的诊断技术的需求是：(1)在救灾反应中检测和控制传染病的传播；(2)监测和应对对国土安全的威胁；(3)确保食品和水的质量；(4)增进不发达国家的健康。在免疫测定和其他分析平台上操纵质量传输效应的能力，以及用于增加分析物和标记通量的流体动力学方法的商业引入，预计将在下一代诊断测试中定义分析速度方面发挥主要作用。

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5).This Small Business Innovation Research Phase I project addresses the need for a low cost technique to significantly minimize the time required to complete a diagnostic test while maintaining and possibly improving analytical and diagnostic sensitivity. The time required to complete an immunometric assay is often dictated by diffusion-based mass transport of antigen and label. Exacerbated by low diffusion coefficients inherent to proteins, viruses, and many other large disease markers, these and many other types of tests can take hours or days to complete. This Phase I proposal focuses on the development of an innovative hydrodynamic approach to increase reactant flux via a free liquid jet delivery system in a framework compatible with existing point-of-care (POC) and clinical instrumentation. The approach is predicated on the hypotheses that (1) mass transport is the rate-limiting step for most molecular recognition-based assays; and (2) the rate of nonspecific adsorption is slower than that of specific binding. This project explores the merits of using a spray jet technique as a means to enhance reactant flux, thereby markedly increasing assay speed while possibly lowering nonspecific adsorption. The broader impacts of this research are enabling the transition of diagnostics to the point of care. The increased focus on preventive healthcare is escalating the demand for rapid POC devices and high throughput clinical tests. The combined patient expectations from healthcare providers and the emergence of wellness testing sets the stage for new POC device genesis and platforms that can increase sample throughput for the in vitro diagnostics industry. Further magnifying the need for diagnostic technologies with as near to real time testing as possible are the needs to: (1) detect and contain the spread of infectious diseases in disaster relief responses; (2) monitor and counter threats to homeland security; (3) assure food and water quality; and (4) advance the health of underdeveloped countries. The ability to manipulate mass transport effects on immunometric and other assay platforms, and the commercial introduction of a hydrodynamic method to increase analyte and label flux, is projected to play a major role in defining assay speed in the next generation of diagnostic tests.