TOPIC 442: QUANTITATIVE TRACEABLE REFERENCE MATERIALS AS MDDTS FOR TISSUE BIOMARKERS

该项目的目标是使免疫组织化学（IHC）测试中的第一个参考标准和测量可追溯性系统成为医疗器械开发工具（MDDT），主题442。在所有其他类型的实验室测试中，如临床化学，这些计量工具是实验室实践的标准。FDA要求测试制造商确定测定校准方法。IHC是个例外。取而代之的是，基于各种组织的免疫反应性，标准化程度很低的临时校准系统。这一缺陷导致免疫组化的错误率是其他实验室检测学科的十倍。波士顿细胞标准公司开发了解决这个问题的工具，并在3个大型临床试验中进行了验证。

This goal of this project is to qualify the first system of reference standards and measurement traceability in immunohistochemistry (IHC) testing as a Medical Device Development Tool (MDDT), topic 442. In all other types of laboratory testing, such as clinical chemistry, these metrologic tools are a standard of laboratory practice. FDA requires test manufacturers to identify methods of assay calibration. IHC is the exception. Instead, there are poorly standardized, improvised systems of calibration based on immunoreactivity with various tissues. This deficiency has led to IHC error rates that are ten times those in other laboratory testing disciplines. Boston Cell Standards developed tools to solve this problem and validated them in 3 large clinical trials. Our proposed MDDT, a system of IHC assay calibration traceable to NIST SRM 1934, is applicable to any manufacturer’s IHC assay. This Phase I proposal addresses 4 improvements that were identified during clinical testing: (1) commutability of reference materials, (2) calculating the difference between “ERF” and molar concentrations, (3) improving traceability to NIST SRM 1934, and (4) developing a better method for calibrator value assignment. These small steps will make a large impact in the field of surgical pathology and IHC.