GB/T 43279.1-2023

Active

Molecular in vitro diagnostic examinations—Specifications for pre-examination processes for venous whole blood—Part 1: Isolated cellular RNA

分子体外诊断检验 静脉全血检验前过程的规范 第1部分:分离细胞RNA

Standard Type
GBT
ICS
11.100.10
CCS
C30
Status
Active
Issue Date
2023-11-27
Implementation
2024-06-01
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 requirements for the handling, transport, storage, and processing of venous whole blood specimens prior to the isolation of cellular RNA for molecular in vitro diagnostic testing. It is applied in clinical laboratories and diagnostic settings to ensure the integrity and quality of RNA extracted from blood cells, which is critical for accurate gene expression analysis and molecular pathology. The standard is particularly relevant for tests involving reverse transcription PCR (RT-PCR) or RNA sequencing used in disease diagnosis, monitoring, and research.

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.