GB/T 42216.1-2022

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 1:Isolated RNA

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1部分:分离RNA

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 RNA from formalin-fixed and paraffin-embedded (FFPE) tissue samples used in molecular in vitro diagnostic testing. It is applied in clinical pathology laboratories and diagnostic settings to ensure consistent handling, storage, and preparation of FFPE tissue-derived RNA for downstream molecular analysis, such as gene expression profiling or biomarker detection. The standard aims to minimize variability and degradation, thereby improving the reliability and reproducibility of diagnostic results 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.