SYNTHETIC CONTROLS FOR IMMUNOHISTOCHEMICAL ASSAYS

描述：（改编自申请人的摘要）的长期目标 这项新的第一阶段应用是开发组织替代控制， 临床免疫组织化学测定。这些替代控件将 标准化，从而取代目前的组织控制， 大部分是实验室独有的这种本土的方法是劳动密集型的， 解决每个样本的试剂故障或程序错误问题 基础有一个共识，即标准化控制的临床 免疫组织化学分析是必要的，如果 available.由于组织特异性对照品具有显著的制备性， 问题，并将是昂贵的调查员和同事 建议开发替代对照，其将使用噬菌体开发 显示技术第一阶段的申请将开发组织抗原 三种常用单克隆抗体的替代物。这些的效用 替代品将在技术测试后在定义的临床场景中进行测试。 确保替代抗原呈递作为免疫治疗的一部分的方法 免疫组织化学方法已得到证实。 拟议商业应用：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