SYNTHETIC CONTROLS FOR IMMUNOHISTOCHEMICAL ASSAYS

描述：(改编自申请者的摘要) 这个新的第一阶段应用程序是开发组织替代控件，用于 临床免疫组织化学检测。这些代理控件将是 标准化，从而取代目前的组织控制，对于 大部分是独一无二的实验室。这种自主开发的方法是劳动密集型的，并不 解决每个样品的试剂故障或程序错误的问题 基础。人们一致认为，临床上的标准化控制措施 免疫组织化学分析是必要的，并将在以下情况下容易采用 可用。由于组织特异性对照提供了重要的准备 问题，而且调查人员和同伙的费用将高得令人望而却步 建议开发将使用噬菌体开发的代理控件 显示技术。这一第一阶段的应用将开发组织抗原 三种常用的单抗的替代物。这些工具的效用 替代物将在确定的临床方案中进行测试，在技术测试之后 方法确保代理抗原呈递作为 免疫组织化学程序已被证明。 建议的商业应用：不可用

DESCRIPTION: (Adapted from the applicant's abstract) The long-term objective of this new Phase I application is to develop tissue surrogate controls for clinical immunohistochemical assays. These surrogate controls are to be standardized and thus replace the tissue controls that are currently, for the most part, lab unique. This homegrown approach is labor intensive and does not address the question of reagent failure or procedure error on a per sample basis. There is a consensus that standardized controls for clinical immunohistochemical analysis are needed and would be readily adopted if available. Since tissue specific controls present significant preparation problems and would be prohibitedly expensive the investigator and associates propose to develop surrogate controls which will be developed using phage display technology. This Phase I application will develop tissue antigen surrogates for three commonly used monoclonal antibodies. The utility of these surrogates will be tested in defined clinical scenarios after the technical methods to insure surrogate antigen presentation as part of the immunohistochemical procedure have been proven. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE