SYNTHETIC CONTROLS FOR IMMUNOHISTOCHEMICAL ASSAYS

本提案的目的是发展替代组织对照临床免疫组化（IHC）分析。目前，每个临床组织学实验室识别，切片，验证，并存档自己的组织对照。这种方法是劳动密集型的，非标准的，并且不能检测到早期的试剂故障或程序错误。在I期研究中，我们开发了IHC实验室中两种最重要的分析物——雌激素和孕激素受体（ER/PR）的合成对照。我们的“合成”对照物是(1)廉价，(2)抗原特异性，(3)取之不尽，(4)标准化，(5)稳定，便于储存，(6)可量化，为测量检测灵敏度提供参考标准。II期具体目标包括：(1)临床验证，导致FDA批准ER/PR对照，以及(2)开发完整的分析物对照面板。第一个具体目标定义了产品的临床效用。第二个目标是我们第一阶段技术的延伸。我们将完成第一阶段开始的任务，创建一个符合临床实验室质量控制需求的合成控制面板。这些合成控制是一个独特的工具，以验证适当的分析性能和最小化分析误差。拟议的商业应用：本拨款提案中描述的技术将为临床免疫组织化学分析提供第一个商业化生产的标准化质量控制系统。无论哪个实验室进行检测，控制对于确保患者检测结果的准确性都很重要。

The objective of this proposal is the development of surrogate tissue controls for clinical immunohistochemical (IHC) assays. Presently, each clinical histology laboratory identifies, sections, validates, and archives their own tissue controls. This method is labor-intensive, non-standard, and does not detect either early reagent failure or procedure error. In the Phase I study, we developed synthetic controls for two of the most important analytes in the IHC laboratory - - estrogen and progesterone receptors (ER/PR). Our "synthetic" controls are (1) inexpensive, (2) antigen-specific, (3) available in an inexhaustible supply, (4) standardized, (5) stable, for ease of storage, and (6) quantifiable, for providing a reference standard against which to measure assay sensitivity. The Phase II specific aims include: (1) Clinical Validation, leading to FDA clearance for the ER/PR controls, and (2) Development of a complete panel of analyte controls. The first specific aim defines the product's clinical utility. The second aim is an extension of our Phase I technology. We will finish the task started in Phase I, to create a panel of synthetic controls that meet the clinical laboratories' quality control needs. These synthetic controls are a unique tool to verify proper assay performance and minimize analytic error. PROPOSED COMMERCIAL APPLICATIONS: The technology described in this grant proposal will provide the first commercially produced, standardized quality control system for clinical immunohistochemical assays. Controls are important to ensure that a patient's test result is accurate, regardless of which laboratory performs the test.