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，并且在检查之前无法诊断 症状的发生。存在公共卫生需求和巨大市场 对于有助于保护血液供应的筛查测试，请进行实时筛查 动物，确保食品安全。我们建议开发并验证 用于检测的创新、高灵敏度筛选方法 人类和动物血液中的传染性朊病毒蛋白。我们已经选择了 增强扩增的分析方法，免疫聚合酶链式反应 (I-PCR) 利用与特定抗体偶联的可扩增 DNA 标记， 并结合血清学和分子诊断潜力来放大微量 蛋白质含量达到可检测水平；该方法是无与伦比的 亚飞克范围内的灵敏度满足建议的标准 检测血液中的朊病毒。将产生重组噬菌体抗体并 用作特异性试剂。初步结果表明概念证明 IPCR方法具有所需的灵敏度。其优势包括：（1）科学的 具有诊断和产品开发专业知识的团队，(2) 选择 高度灵敏的分析方法和新颖的检测探针，以及（3） 强大的业务合作伙伴，拥有将原型检测转化为专业知识的专业知识 敏感、特异和可重复的产品。 拟议的商业应用：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（例如牛肉和牛脑）而感染疾病的可能性具有重要意义。 针对朊病毒的灵敏 I-PCR 检测还可防止有据可查的通过使用人类生长激素、硬脑膜、器官移植引起的医源性传播病例，以及通过手术治疗传播的可能性。 商业应用还扩展到人类和动物健康项目的流行病学监测，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.