GB/T 42216.4-2024

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue—Part 4: In situ detection technique

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4部分:原位检测技术

Standard Type
GBT
ICS
11.100.10
CCS
C30
Status
Active
Issue Date
2024-08-23
Implementation
2025-03-01
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 of formalin-fixed, paraffin-embedded (FFPE) tissue samples intended for in situ detection techniques, such as immunohistochemistry or fluorescence in situ hybridization. It is applied in clinical pathology laboratories and molecular diagnostic settings to ensure consistent sample preparation, fixation, and processing prior to testing. The standard aims to minimize variability and pre-analytical errors, supporting reliable diagnostic outcomes in cancer and other disease testing.

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.