GB/T 42080.1-2022

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for frozen tissue—Part 1: Isolated RNA

分子体外诊断检验 冷冻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 requirements for the handling, storage, and processing of frozen tissue specimens prior to RNA extraction for molecular in vitro diagnostic testing. It is applied in clinical laboratories and pathology settings to ensure the quality and integrity of isolated RNA, which is critical for downstream analyses such as gene expression profiling or disease diagnosis. The standard helps standardize pre-examination procedures to minimize variability and errors in diagnostic results.

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.