GB/T 42080.2-2022

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part2:Isolated proteins

分子体外诊断检验 冷冻组织检验前过程的规范 第2部分：分离蛋白质

Standard Type
GBT
ICS
11.100.10
CCS
C30
Status
Active
Issue Date
2022-12-30
Implementation
2023-07-01
Centralized Committee
国家药监局
Issuing Authority
国家市场监督管理总局、国家标准化管理委员会

Application Summary AI generated

This standard specifies the requirements for the handling, documentation, and processing of frozen tissue specimens prior to protein isolation for molecular in vitro diagnostic examinations. It is applied in clinical laboratories and pathology settings to ensure the quality and integrity of proteins extracted from frozen tissue samples, directly impacting the accuracy of downstream diagnostic tests such as immunohistochemistry or mass spectrometry-based proteomics. The standard is particularly relevant for healthcare professionals and manufacturers involved in pre-analytical processes for cancer diagnostics or biomarker research.

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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.