GB/T 40982-2021

Active

Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) nucleic acid detection kit

新型冠状病毒核酸检测试剂盒质量评价要求

Standard Type
GBT
ICS
11.100.10
CCS
C44
Status
Active
Issue Date
2021-11-26
Implementation
2022-03-01
Centralized Committee
国家药监局
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 quality assessment requirements for SARS-CoV-2 nucleic acid detection kits, including performance indicators such as sensitivity, specificity, and precision. It is applied in the manufacturing, quality control, and regulatory evaluation of these kits used in clinical laboratories and medical testing facilities. The standard ensures the reliability and accuracy of COVID-19 diagnostic tests in China.

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.