On March 17th, NMPA has approved the 14th New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) produced by Zybio. Up to now, 14 COVID-19 antigen detection kits have been approved for sale. Since the outbreak of the COVID-19, NMPA has approved 37 New Coronavirus nucleic acid detection kits, 36 antibody detection kits, and 14 antigen detection kits, helping to prevent and control the epidemic.
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, NMPA issued the second batch of 5 COVID-19 antigen self-test approval documents, all of which are colloidal gold methods. The approved companies on that 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 14 COVID-19 antigen detection reagents have been approved for marketing. Among them, 10 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.
ZHEJIANG ORIENT GENE BIOTECH Co.,Ltd.( A2-0301)
Wuhan EasyDiagnosis Biomedicine Co.,Ltd.( A4-1314)
Zybio Inc.( A3-2809)
Two are latex method: Beijing Jinwofu Bioengineering Technology Co., Ltd. and ACon Biotech(Hangzhou)Co.,Ltd.( A2-2514).
Two of them are fluorescence immunochromatography, BGI PathoGenesis Pharmaceutical Technology Co., Ltd and Beijing Savant Biotechnology Co.,Ltd. (A3-2319).
