GB/T 37871-2019

Active

Technical specification for quality evaluation of nucleic acid test kit

核酸检测试剂盒质量评价技术规范

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, test methods, and evaluation criteria for assessing the quality of nucleic acid test kits. It is applied in clinical diagnostics, disease control laboratories, and in vitro diagnostic manufacturing to ensure the accuracy, sensitivity, and specificity of kits used for detecting pathogens such as viruses or bacteria. The standard is particularly relevant for quality control during production, procurement, and regulatory approval of test kits.

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.