It is convenient and quick to detect COVID-19 antigen on the test paper through the binding reaction between antigen and antibody, and the result can be obtained in 15-20 minutes. However, the antigen-antibody reaction will be false positive due to some interference, and the specificity of the method can not reach 100%. Therefore, the antigen test results cannot replace the nucleic acid test results.
On March, 2022, 1 1, "COVID-19 Antigen Detection Application Scheme (Trial)" was released. As of April 65438, 2003, the State Administration of Pharmaceutical Products has approved 27 kinds of COVID-19 antigen detection reagent products.
On March 12, 2022, the State Administration of Pharmaceutical Products issued an announcement, approving the changes in the self-inspection applications for COVID-19 antigen products of Novozymes Nanjing, Jinwowu Beijing, Yuan Yin Huada Shenzhen, Wanfu Bio Guangzhou and Huaketai Bio Beijing. Since then, five COVID-19 antigen self-test products have been officially listed.
On March 65438+March 3, 2022, the State Administration of Pharmaceutical Products approved the applications for registration of five COVID-19 antigen detection kits, including Beijing Wan Tai Biopharmaceutical Co., Ltd., Beijing Rejing Biotechnology Co., Ltd., Tianjin Boao Seth Biotechnology Co., Ltd., Chongqing Ming Dow Jiece Biotechnology Co., Ltd. and Beijing Lepu Diagnostic Technology Co., Ltd.
On the evening of March 65438+May, 2022, the State Administration of Pharmaceutical Products approved the application for registration of COVID-19 antigen self-test products of Wuhan Mingde Biotechnology Co., Ltd. and Zhejiang Dongfang Gene Biological Products Co., Ltd.
On the evening of March 16, 2022, the State Administration of Medical Supplies approved the application for registration of COVID-19 antigen self-test products of Ai Kang Biotechnology (Hangzhou) Co., Ltd.
On March 7, 2022, the State Medical Supplies Supervision and Administration approved the application for registration of COVID-19 antigen detection reagent products of Zhongyuan Huiji Biotechnology Co., Ltd.
March, 2022 18 Kang Hua Biology &; Novel coronavirus (20 19-nCoV) antigen test kit (colloidal gold method) developed by Qingdao Hantang Biological Co., Ltd. was officially listed with the approval of the State Administration of Pharmaceutical Products, which is the first COVID-19 antigen test kit approved for listing in Shandong Province.
In March, 2022, novel coronavirus antigen testing project was temporarily added in Qinghai Province, and the government-guided price was 5 yuan/person. On April 3, 2022, antigen testing was conducted in Shanghai.