GB/T 40966-2021 Active National standards

GB/T 40966-2021 Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) antigen detection kit

Publish Date: 2021-11-26 Implement Date: 2022-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 40966-2021

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-11-26

Implement Date: 2022-03-01

Pages: 9 pages

Scope

This document sets out the quality evaluation requirements, test methods, labels and instructions, packaging, transportation, and storage for novel coronavirus antigen detection kits. This document is applicable to the quality evaluation of novel coronavirus antigen detection kits that use upper respiratory tract samples such as pharyngeal swabs, nasal swabs, and saliva; blood samples such as serum, plasma, and whole blood; and lower respiratory tract samples such as sputum, respiratory tract aspirates, bronchial lavage fluid, and alveolar lavage fluid as detection samples.