Detection of Prion Protein in Blood

描述（由申请人提供）：朊病毒疾病是100%致命的， 没有可用的治疗方法，并且在治疗前无法诊断。 出现症状。有公共卫生需求和巨大的市场 对于一个筛选测试，可以帮助保护血液供应，屏幕活 动物，确保食品安全。我们建议开发和验证一个 创新的，高灵敏度的筛选方法，用于检测 人类和动物血液中的传染性朊病毒蛋白。我们选择 扩增增强分析方法，免疫聚合酶链反应 （I-PCR），其利用与特异性抗体偶联的可扩增DNA标记， 并结合血清学和分子诊断潜力来扩增微量 将蛋白质含量提高到可检测的水平;这种方法是无与伦比的 亚毫微微克范围内的灵敏度符合为 血液中朊病毒的检测将产生重组噬菌体抗体， 用作特定试剂。初步结果表明， IPCR方法具有所需的灵敏度。优势包括：（1）科学 具有诊断和产品开发专业知识的小组，（2）选择 高灵敏度的分析方法和新型检测探针，以及（3） 强大的业务合作伙伴，具有将原型分析转化为 灵敏、特异、可重复的产品。 拟定商业应用：检测朊病毒疾病的能力对于确保血液供应的安全和消除通过摄入某些食物（如牛肉和牛脑）获得疾病的可能性具有重要意义。 敏感的朊病毒I-PCR检测还将防止通过使用人类生长激素、硬脑膜、器官移植进行医源性传播的有据可查的病例，以及通过使用手术治疗进行传播的可能性。 商业应用还扩展到人类和动物健康计划的流行病学监测，以及食品，药品和疫苗行业。

DESCRIPTION (provided by applicant): Prion diseases are 100 percent fatal, there is no treatment available, and cannot be diagnosed prior to the occurrence of symptoms. There is a public health need and an enormous market for a screening test that can help protect the blood supply, screen live animals, and ensure food safety. We propose to develop and validate an innovative, highly sensitive screening method for the detection of the infectious prion protein in the blood of humans and animals. We have selected an amplification-boosted analytical method, immuno-polymerase chain reaction (I-PCR) that utilizes an amplifiable DNA-label coupled to a specific antibody, and combines serologic and molecular diagnostic potentials to amplify micro quantities of protein to detectable levels; the method's unparalleled sensitivity in the sub-femtogram range meets the criterion proposed for detection of prion in blood. Recombinant phage antibodies will be produced and used as specific reagents. Preliminary results have shown proof of concept that IPCR method has the needed sensitivity. The strengths include: (1) a scientific group with expertise in diagnostics and product development, (2) the selection of a highly sensitive analytical approach and novel detection probes, and (3) a strong business partner having expertise in translating prototype assays into sensitive, specific, and reproducible products. PROPOSED COMMERCIAL APPLICATION: The ability to detect prion diseases is significant for ensuring the safety of the blood supply and eliminating the possibility of acquiring disease through the ingestion of certain foods such as beef and beef brains. The sensitive I-PCR assay for Prion will also prevent well-documented cases of iatrogenic transmission through the use of human growth hormone, dura mater, organ transplantation, and the likelihood of transmission through the use of surgical treatment. Commercial applications also extend to the epidemiologic surveillance of human and animal healthy programs, as well as food, drug and vaccine industries.