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

本项目的目标是将免疫组织化学（IHC）试验中的第一个参考标准和测量可追溯性系统鉴定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要求检测试剂盒制造商确定检测试剂盒校准方法。IHC是个例外。相反，存在基于与各种组织的免疫反应性的标准化差的临时校准系统。这一缺陷导致IHC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一问题的工具，并在3项大型临床试验中进行了验证。 我们提出的MDDT是一种可追溯至NIST SRM 1934的IHC测定校准系统，适用于任何制造商的IHC测定。本I期提案涉及临床试验期间确定的4项改进：（1）参比物质的可重复性，（2）计算“ERF”和摩尔浓度之间的差异，（3）提高NIST SRM 1934的可追溯性，以及（4）开发更好的校准品赋值方法。这些小步骤将在外科病理学和IHC领域产生巨大影响。

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.