T/ZSMM 0004-2023 Active Group standards

T/ZSMM 0004-2023 Immunohistochemistry staining color calibration quality control method

Publish Date: 2023-12-22 Implement Date: 2024-01-22 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/ZSMM 0004-2023

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Laboratory medicine

Publish Date: 2023-12-22

Implement Date: 2024-01-22

Scope

Scope: This standard specifies the terminology and definitions, abbreviations, methodological principles, reagents and materials, instruments and equipment, preparation of general quality control materials, IHC experimental steps, and immunohistochemical staining colorimetric calibration (MCC) and immunohistochemical staining quality control data related to the calibration of immunohistochemical staining colorimetry. This standard is applicable to pathologists or researchers conducting colorimetric calibration and quality control of immunohistochemical staining reactions, validating and evaluating the quality of immunohistochemical reaction processes, and establishing final quality control norms for immunohistochemical staining results. Main technical content: Currently, pathologists in China have long lacked a technical method for conducting in-house quality control (IQC) and inter-laboratory quality assessment (EQA) of immunohistochemical staining. In recent years, with the application of digital pathology, remote diagnosis, and artificial intelligence, especially targeted drugs such as PD1/PDL1, there is an increasing demand for objective and quantitative evaluation standards for immunohistochemical staining quality. After research, it was decided to develop the "Immunohistochemical Staining Colorimetric Calibration Quality Control Methods" group standard to guide relevant practitioners and researchers to familiarize themselves with and master the key points of immunohistochemical staining colorimetric calibration quality control methods represented by MCC technology, which can effectively solve the most core problem of specimen quality control, achieve unified evaluation standards among different laboratories, achieve mutual recognition and interoperability of diagnostic results, share data, avoid medical resource waste caused by different quality standards among different institutions, and simultaneously improve the efficiency of pathological diagnosis and tre