Views: 0 Author: Site Editor Publish Time: 2022-09-14 Origin: Site
The detection of new coronavirus antigen is carried out on the test strip by antigen and antibody binding reaction, which is convenient and quick. The results can be obtained in 15-20 minutes. However, the antigen antibody reaction will appear false positive because of some interference, and the specificity of methodology is less than 100%. Therefore, the results of antigen detection cannot replace the results of nucleic acid detection.
On March 11, 2022, the Application Scheme for Detection of New Coronavirus Antigen (Trial) was released. As of April 13, the State Food and drug administration has approved 27 novel coronavirus antigen detection reagent products.
On March 12, 2022, the State Food and Drug Administration issued a notice to approve the change of self-test application of covid-19 antigen products of Nanjing novozan, Beijing jinwofu, Shenzhen Huada Yinyuan, Guangzhou Wanfu biology and Beijing huaketai biology. Since then, five self-test products for covid-19 antigen have been officially launched.
On March 13, 2022, the State Food and Drug Administration approved the registration application of five new crown antigen test kit products, including Beijing Wantai Biomedical Co., Ltd., Beijing Rejing Biotechnology Co., Ltd., Tianjin Boosis Biotechnology Co., Ltd., Chongqing Mingdao Jiete Biotechnology Co., Ltd., and Beijing Lepu Diagnostic Technology Co., Ltd.
On the evening of March 15, 2022, the State Food and Drug Administration approved the registration application of Wuhan Mingde Biotechnology Co., Ltd. and Zhejiang Dongfang Gene Biological Products Co., Ltd. for new crown antigen self-test products.
On the evening of March 16, 2022, the State Food and Drug Administration approved the registration application for the new crown antigen self-test product of Aikang Biotechnology (Hangzhou) Co., Ltd.
On March 17, 2022, the registration application of novel coronavirus antigen detection reagent products of Zhongyuan Huiji Biotechnology Co., Ltd. was approved by the State Food and drug administration.
On March 18, 2022, the new coronavirus (2019 nCoV) antigen test kit (colloidal gold method) developed by Shandong Kanghua Biotech&Qingdao Hantang Biotech was approved by the State Food and Drug Administration for official listing, which is the first new coronavirus antigen test kit approved for listing in Shandong.
In March 2022, Qinghai Province will temporarily add a new type of coronavirus antigen detection project, with the government guidance price of 5 yuan/person time.
On April 3, 2022, Shanghai will conduct an antigen test in the whole city.
On March 11, 2022, according to the news on the official website of the National Health Commission, after research, the Comprehensive Group of the Joint Prevention and Control Mechanism of the State Council for New Coronavirus Pneumonia decided to add antigen detection as a supplement on the basis of nucleic acid detection, and organized the formulation of the Application Scheme for New Coronavirus Antigen Detection (Trial).
Annex 1: basic requirements and procedures for novel coronavirus antigen testing in primary medical and health institutions
Annex 2: basic requirements and process of novel coronavirus antigen self-test [5]
National Medical Insurance Bureau: the covid-19 antigen testing reagents and corresponding testing items will be temporarily included in medical insurance. Basis: Notice of the Office of the National Medical Security Bureau on Doing a Good Job in the Medical Security Work for the Prevention and Control of the Current Epidemic Situation (YIBF [2022] No. 3)
