GB/T 37868-2019

Active

Technical specification for traceability of nucleic acid test kit

核酸检测试剂盒溯源性技术规范

Standard Type
GBT
ICS
07.080
CCS
G00
Status
Active
Issue Date
2019-08-30
Implementation
2019-08-30
Centralized Committee
国家标准委
Issuing Authority
国家市场监督管理总局、中国国家标准化管理委员会

Application Summary AI generated

This standard specifies the technical requirements for establishing and maintaining the metrological traceability of nucleic acid test kits, ensuring that measurement results are linked to reference standards. It is applied in clinical diagnostics, biotechnology, and public health laboratories for quality control of PCR-based kits used in detecting pathogens like SARS-CoV-2 or genetic markers. The standard supports regulatory compliance and inter-laboratory result comparability in medical testing and in vitro diagnostics.

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.