GB/T 40984-2021
ActiveQuality assessment requirements for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） IgM antibody detection kit
新型冠状病毒IgM抗体检测试剂盒质量评价要求
Application Summary AI generated
This standard specifies quality assessment requirements for SARS-CoV-2 IgM antibody detection kits, including performance criteria such as sensitivity, specificity, and precision. It is applied in medical and public health settings for evaluating the reliability of serological test kits used in COVID-19 diagnosis, surveillance, and immune response monitoring. The standard ensures consistent quality control for manufacturers and regulatory bodies in China.
Related Standards
GB/T 19634-2005
In vitro diagnostic test systems-General technical requirements for blood-glucose monitoring systems for self-testing
GB/T 47486-2026
General technical requirements for vasculature-on-a-chip
GB/Z 30154-2013
Medical laboratories―Guidance on laboratory implementation of GB/T 22576-2008
GB/Z 16886.22-2022
Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/Z 43281-2023
Guidance for supervisors and operators of point-of-care testing(POCT) devices
GB/Z 43280-2023
Medical laboratories—Practical guidance for the estimation of measurement uncertainty
GB/Z 44363-2024
Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/Z 136-2026
Medical laboratories—Reagents for staining biological specimen—Guidance for users
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.