RAPID, INEXPENSIVE ASSAY FOR INFLUENZA A

这项建议旨在解决持续开发一种快速、廉价的 筛查鼻咽分泌物中甲型流感的方法 利用一种新型的生物传感器，分子识别/结合作为 探测元件和专有的集成光学干涉仪 换能器。干涉仪的独特设计允许直接 定量测定极低浓度的特定生物分子 流体样本。该方法依赖于对小屈光度的检测 干涉仪表面的折射率变化。当受体 分子被固定在干涉仪表面上，随后 特定配体的结合导致显著的折射率 变化。基于这种方法的检测具有许多关键优势：1) 它快速(不到5分钟)，2)它很灵敏(不到104 Pfu/毫升)，3)简单(没有标签或标签)和4)低 成本(低于成本，不需要昂贵的分析仪器)。这个 生物传感器可封装为手持设备，适用于实验室外 使用。此外，这项技术提供了同时 检测几种呼吸道感染(例如：甲型流感、流感 B、RVS、副流感)。第一阶段的实验已经 论证了概念的可行性，现在建议继续进行 临床原型的第二阶段开发和测试。 拟议的商业应用：流感的独特之处在于它能够 每年引起呼吸道疾病的流行，并位居领先地位 美国死亡率过高的原因。建议的化验方法将 提供一种快速、低成本的工具来检测机构暴发的 甲型流感(金刚烷胺或金刚乙胺可用于控制)和 用于作出鉴别诊断(例如，年轻人的流感与呼吸道合胞病毒 老年、流感与所有年龄段的汉坦病毒感染)。

This proposal addresses the continued development of a rapid, inexpensive assay to screen nasopharyngeal secretions for influenza A. The assay utilizes a novel biosensor, with molecular recognition/binding as the detection element and a proprietary, integrated optic interferometer as the transducer. The unique design of the interferometer allows direct quantification of very low concentrations of specific biomolecules in a fluid sample. The approach relies on the detection of small refractive index changes at the surface of the interferometer. When receptor molecules are immobilized on the interferometer surface, the subsequent binding of specific ligands results in a pronounced refractive index change. An assay based on this approach has a number of key advantages: 1) it is rapid (less than 5 minutes), 2) it is sensitive (less than 104 pfu/milliliter), 3) it is simple (no labeling or tagging) and 4) it is low cost (less than cost, no expensive analytic instrumentation). The biosensor can be packaged as a hand-held device, suitable for out-of-lab use. Moreover, the technology offers the potential of simultaneously testing for several respiratory infections (e.g.; influenza A, influenza B, RVS, parainfluenza) in a single assay. Phase I experiments have demonstrated concept feasibility, and it is now proposed to proceed to Phase II development and testing of a clinical prototype. PROPOSED COMMERCIAL APPLICATION: Influenza is unique in its ability to cause annual epidemics of respiratory illness and ranks among the leading causes of excess mortality in the United States. The proposed assay would provide a rapid, low-cost tool for detecting institutional outbreaks of influenza A (which amantadine or rimantadine might be used to control) and for making differential diagnoses (eg; influenza vs. RSV in the young and old, influenza vs. hantavirus infection at all ages).