GB/T 42216.2-2022

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded(FFPE) tissue—Part 2:Isolated proteins

分子体外诊断检验 福尔马林固定及石蜡包埋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 pre-examination processes for isolating proteins from formalin-fixed and paraffin-embedded (FFPE) tissue samples used in molecular in vitro diagnostic testing. It is applied in clinical laboratories and pathology settings to ensure consistent, high-quality protein extraction for downstream diagnostic assays, such as immunohistochemistry or mass spectrometry-based proteomics. The standard helps minimize variability and errors in protein analysis from archived FFPE specimens, which are commonly used in cancer research and personalized medicine.

Related Standards

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.