SYNTHETIC CONTROLS FOR IMMUNOHISTOCHEMICAL ASSAYS

本提案旨在开发用于临床免疫组织化学（IHC）检测的替代组织质控品。目前，每个临床组织学实验室识别，切片，验证和存档自己的组织控制。该方法是劳动密集型的，非标准的，并且不能检测早期试剂失效或程序错误。在I期研究中，我们为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）开发了合成对照品。我们的“合成”质控品是（1）廉价的，（2）抗原特异性的，（3）取之不尽，用之不竭，（4）标准化的，（5）稳定的，易于储存，和（6）可定量的，用于提供参考标准，以测量测定灵敏度。II期的具体目标包括：（1）临床验证，导致ER/PR质控品获得FDA批准，以及（2）开发完整的分析物质控品组。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扩展。我们将完成第一阶段开始的任务，创建一组满足临床实验室质量控制需求的合成对照。这些合成质控品是一种独特的工具，可用于验证正确的检测性能并最大限度地减少分析误差。拟议的商业应用：本资助申请中描述的技术将为临床免疫组织化学检测提供第一个商业化生产的标准化质量控制系统。 控制是重要的，以确保患者的测试结果是准确的，无论哪个实验室进行测试。

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.