Two COVID-19 Antigen Detection Kits Have Been Approved

On November 3, COVID-19 (2019-NCOV) antigen detection kit (Colloidal Gold method) of Guangzhou Wondfo Biotech Co., Ltd. and COVID-19 (2019-NCOV) antigen detection kit (Latex method) of Beijing Kingcraft Biotech Co., Ltd. were approved by China National Medical Products Administration.

These two products approved above are the first COVID-19 antigen detection reagent approved in China. The testing time is controlled within 20 minutes. Those tests could quickly screen positive cases at high viral load during acute infectious period, so they can be used for early triage and rapid management of suspected populations.

Antigen detection can be used as a supplement to existing detection methods and cannot be used solely for the diagnosis of COVID-19 infection. Instead, it should be combined with other diagnostic information such as nucleic acid test, imaging, medical history and contact history to determine the status of infection. Further nucleic acid testing should be performed for both positive and negative antigen results in suspected populations.

The approval of above two products enriched the category of COVID-19 detection reagents, expanded the supply of COVID-19 detection reagents, and further served the need of epidemic prevention and control.

So far, National Medical Products Administration has approved 24 nucleic acid detection reagents, 25 antibody detection reagents and 2 antigen detection reagents for COVID-19 in total.