Rapid Immunoassays for Detecting Pathogenic Bacteria

描述(申请人提供)：建议开发一种手持式电化学免疫分析系统，用于同时检测环境样品中的多种致病菌。该系统满足了对便携式、灵敏、定量设备的需求，供急救人员使用，能够快速识别疑似接触细菌战(BW)制剂的样本。该系统将通过提高检测灵敏度并允许对病原体进行量化，改进目前可用的BW试剂快速检测。 第一阶段的具体目标是制造用于检测两种不同致病菌类型的概念验证电化学免疫检测方法，展示同时检测和量化细菌的方法，并证明与目前可用的BW快速检测相比，电化学检测方法的灵敏度有所提高。该系统将用于分析疑似BW制剂污染的样本，但也将应用于其他领域，如食品和水安全、农业和牲畜监测、法医和临床诊断。除细菌外，该系统还将适用于其他BW制剂类型的检测，包括病毒、立克次体和毒素。第一阶段计划将展示我们系统的可行性，提供概念验证电化学分析，将在第二阶段开发成包含传感电极的更高密度的分析条，用于更广泛的BW重要细菌，以及开发原型电化学分析读取器。快速筛选多种致病污染物的可靠且经济有效的方法有可能成为许多国防、环境、临床和生物应用中的宝贵工具。在生物恐怖主义的威胁以及对更便宜和更好的探测的需求的推动下，化学和生物战探测器的世界市场可能会增长。这是为我们的技术创造一个利基市场的绝佳机会，我们的技术比目前的检测方法更具优势。客户包括军事服务、安全部队、急救人员、紧急医疗服务、处理化学/生物武器非军事化的项目以及食品和水行业。EIC通过内部制造、销售电化学分析和手持检测读取器，以及我们的多分析免疫分析技术的外部许可，为检测技术提供了一条商业途径。

DESCRIPTION (provided by applicant): The development of a hand-held electrochemical immunoassay system for the simultaneous detection of multiple pathogenic bacteria in environmental samples is proposed. The system addresses the need for portable, sensitive, quantitative devices for use by first-responders, capable of rapidly identifying samples suspected of exposure to bacterial biological warfare (BW) agents. The system will improve on currently available BW agent rapid tests by increasing assay sensitivity and allowing quantification of pathogens. The specific aims of the Phase I are to fabricate proof-of-concept electrochemical immunoassays for detecting two different pathogenic bacteria types, demonstration of the assays to simultaneously detect and quantify the bacteria, and demonstration of improved sensitivity of the electrochemical assays compared to currently available BW rapid tests. The system will be used for the analysis of samples suspected of BW agent contamination, but will also have applications in other areas such as food and water safety, agricultural and livestock monitoring, forensics and clinical diagnosis. In addition to bacteria, the system will be suitable for the detection of other BW agent types, including viruses, rickettsiae and toxins. The Phase I program will demonstrate the feasibility of our system, providing proof-of-concept electrochemical assays which will be developed in Phase II into higher-density assay strips containing sensing electrodes for a wider range of bacteria of BW significance, together with the development of a prototype electrochemical assay reader. Robust and cost-effective methods for rapidly screening for multiple pathogenic contaminants hold the potential to becoming valuable tools in numerous defense, environmental, clinical, and biological applications. The world market for chemical and biological warfare detectors will likely grow, fueled by the threat of bioterrorism, and the demand for cheaper and improved detection. There is an excellent opportunity to create a niche for our technology, which has advantages over current methods of detection. Customers include military services, security forces, first responders, emergency medical services, programs that deal with chemical/biological weapons demilitarization, and food and water industry. EIC has a commercial path for assay technology through in-house manufacturing, sale of electrochemical assays and hand-held assay readers, and out-licensing of our multianalyte immunoassay technology.