At present, pathologists in my country have long lacked a technical method that can conduct indoor quality control (IQC) and inter-laboratory quality assessment (EQA) of each immunohistochemistry slice. In recent years, with the application of digital pathology, remote diagnosis, and artificial intelligence, especially targeted drugs represented by PD1/PDL1, there has been an increasing demand for objective and quantitative evaluation standards for immunohistochemistry color development quality. After research, it was decided to compile a group standard for "Quality Control Methods for Immunohistochemistry Staining and Color Calibration" to guide relevant practitioners and researchers to become familiar with and master the key points of quality control methods for immunohistochemistry and color calibration represented by MCC technology, which can effectively solve The core issue of production quality control is to achieve unified evaluation standards between different laboratories, achieve mutual recognition and interoperability of diagnostic results, and data sharing, avoid the waste of medical resources caused by different quality standards between different institutions, and also synchronize It has improved the efficiency of pathological diagnosis and treatment in our country and benefited the general public. This document is suitable for pathological technicians or researchers to perform color calibration quality control management of immunohistochemical staining reactions, verify and evaluate whether the immunohistochemical reaction process is qualified, and form the final quality control specification for immunohistochemical staining results. This standard provides terms and definitions, abbreviations, method principles, reagents and materials, instruments and equipment, preparation of general quality control substances, IHC experimental procedures, and immunohistochemical staining and color calibration methods related to immunohistochemical staining and color calibration methods. Methods and immunohistochemical staining quality control data storage format.
T/ZSMM 0004-2023 history
2023T/ZSMM 0004-2023 Method of calibrating coloration for immunohistochemistry