SBIR Phase II: Inexpensive and Effecient System for Signal Amplification

这个小型企业创新研究(SBIR)第二阶段项目建议开发一种新的信号放大系统，该系统价格低廉，使用简单，可以与抗体或其他探针分子结合，可以将传统的酶联免疫吸附试验(ELISA)的检测极限提高100到1000倍。酶联免疫吸附试验在科学和诊断方面已经使用了40多年。酶联免疫吸附试验是一种简单、可靠、廉价的检测方法。然而，由于这项技术中使用的酶作为信号产生和放大装置的性质，它的灵敏度相对较低。在第一阶段，研究表明，用能够繁殖并同时产生光信号的噬菌体取代这些酶，大大提高了ELISA的灵敏度，同时在不使其操作复杂的情况下降低了检测成本。在第二阶段，目标是进一步提高系统的灵敏度和响应时间，并创造两种类型的产品：1)可插入传统ELISA系统的组件，2)专为检测特定毒素和其他病原体而设计的试剂盒。该项目的更广泛影响/商业潜力预计将影响基础研究、生物防御和医学领域。拟议的系统将允许非常灵敏和廉价的选择抗原检测。对于那些参与基础研究的人来说，拟议的免疫分析将允许对生物过程进行更详细的分析，甚至可能打开监测那些以前无法检测到的过程和分子的大门。在生物防御和医学诊断中，更高的灵敏度将意味着更高的安全性，因为它允许更早地检测有害病原体，以及人类有机体的病理变化。

This Small Business Innovation Research (SBIR) Phase II project proposes to develop a new signal amplification system that, while being inexpensive and simple to use, can be combined with antibodies or other probe molecules and can increase detection limits of conventional Enzyme-linked immunosorbent assay (ELISA) by 100 to 1000-fold. ELISA has been used both in science and diagnostic for more than 40 years. ELISA is simple, reliable, and inexpensive technique. However, because of the nature of enzymes used in this technique as signal-generating and amplifying device, it has a relatively low sensitivity. During Phase I, it was demonstrated that substitution of these enzymes with phages that can propagate and simultaneously generate light signal substantially increases the sensitivity of ELISA and simultaneously reduces cost of the assay without complicating its protocol. In Phase II, the goal is to further improve sensitivity and response time of the system and create two types of products: 1) components that can be plugged-in into conventional ELISA system, and 2) kits designed for detection of specific toxins and other pathogens.The broader impact /commercial potential of this project is expected to impact the areas of basic research, biodefense, and medicine. The proposed system will allow very sensitive and inexpensive detection of antigens of choice. For those involved in basic research, the proposed immunoassay will allow a significantly more detailed analysis of biological processes, possibly even opening the doors to monitoring those processes and molecules previously undetectable. In biodefense and medical diagnostics, increased sensitivity will mean an increased security by allowing earlier detection of harmful pathogens, as well as pathological changes in the human organism.