GB/T 42216.3-2022

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 3:Isolated DNA

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3部分:分离DNA

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 requirements for the pre-examination handling, documentation, and processing of formalin-fixed and paraffin-embedded (FFPE) tissue specimens to ensure the quality and integrity of isolated DNA for molecular in vitro diagnostic testing. It is applied in clinical laboratories and pathology settings where FFPE tissue samples are used for downstream molecular analyses, such as genetic testing or cancer biomarker detection. The standard ensures consistent and reliable DNA extraction procedures, minimizing variability that could affect diagnostic accuracy.

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.