Several COVID-19 antigen detection reagents have been approved for marketing recently

Recently, the domestic epidemic situation is severe, and the release of the "Plan" further optimizes the COVID-19 detection strategy to serve the needs of epidemic prevention and control.

The "Plan" specifies the applicable population for antigen testing:

First, people who go to primary medical and health institutions for treatment, have respiratory symptoms, fever and other symptoms and have symptoms within 5 days; Second, the people in isolation observation, (including home isolation observation), the close and sub-close contact, people entry isolation observation, closed control area and personnel in control area; Third, community residents who need antigen self-testing.

The “Plan” defines the main condition, for the three types of people above, and clear the obtaining methods of detection reagents. If the virus is detected, the “plan” also formulates the management process.

On March 13, the State Food and Drug Administration issued the second batch of 5 COVID-19 antigen self-test approval documents, all of which are colloidal gold methods.  The approved companies this time are Beijing WANTAI Biological Pharmacy Enterprise Co.,Ltd. （A2-2909 in 2022 CACLP）, Beijing Hotgen Biotech Co.,Ltd. (A4-2809) , Beijing LEPU Medical Technology Co.,Ltd. (A2-0601), Tianjin Bioscience Diagnostic Technology Co.,Ltd. (A3-2201) and Chongqing M&d Biotechnology Co. Ltd.

Up to now : A total of 10 novel coronavirus antigen detection reagents have been approved for marketing. Among them, 7 are colloidal gold methods, namely Guangzhou Wondfo Biotech Co.,Ltd. (A4-0501 in CACLP 2022), Nanjing Vazyme Medical Co.,Ltd. (A4-1319), Beijing Hotgen Biotech Co.,Ltd. (A4-2809), Beijing WANTAI Biological Pharmacy Enterprise Co.,Ltd. (A2-2909), Tianjin Bioscience Diagnostic Technology Co.,Ltd. (A3-2201), Beijing Lepu Medical Technology Co.,Ltd. (A2-0601), Chongqing M&d Biotechnology Co. Ltd. One is latex method, Beijing Jinwofu Bioengineering Technology Co., Ltd. Two of them are fluorescence immunochromatography, BGI PathoGenesis Pharmaceutical Technology Co., Ltd and Beijing Savant Biotechnology Co.,Ltd. (A3-2319).