Today, Shanghai's first COVID-19 antigen detection product was obtained from China's medical device registration certificate. The New Coronavirus antigen detection kit developed by Shanghai core Biotechnology Co., Ltd. was obtained by the State Administration of pharmacy registration certificate. With the support of the Municipal Science and Technology Commission, the Municipal Food and drug administration, the Municipal Economic and Information Technology Commission and the Municipal Health Commission, the core super biological team has worked all night for half a month, and finally completed the application process of registration certificate, allowing covid-19 antigen detection products produced in Shanghai to enter the Chinese market.
On March 11, the National Health Commission issued the application scheme for covid-19 virus antigen detection (Trial), promoted the monitoring mode of "antigen screening and nucleic acid diagnosis", and added antigen detection as a supplementary means of nucleic acid detection. After the release of the plan, the Shanghai Municipal Science and Technology Commission, the Shanghai food and drug administration, the Shanghai Municipal Economic and Information Technology Commission and the Shanghai Municipal Health and Health Commission immediately set up a special working class to focus on the application of covid-19 antigen detection product registration certificates of five enterprises, including core superbiology, Shanghai Zj Bio-Tech Co.Ltd(688317) , Shanghai Kehua Bio-Engineering Co.Ltd(002022) , Fosun diagnosis and Berger medical, and complete clinical trials, production coordination and material approval as soon as possible.
At present, core superorganism is at the forefront. The company is a subsidiary of biochip Shanghai National Engineering Research Center. In April 2020, the New Coronavirus antibody detection kit (colloidal gold method) developed by the company was approved by the State Administration of drug supervision and quarantine, and became the only COVID-19 antibody test kit approved in Shanghai. In the same year, the covid-19 nucleic acid, antibody, antigen and neutralizing antibody test kits developed by this enterprise obtained EU CE certification and entered the export white list of China Medical Insurance chamber of Commerce.
After the release of China's covid-19 antigen detection application scheme, the antigen detection products have been quickly responded by the core superorganism recognized by the EU, and a research team was immediately established. Professor Gao Hengjun, director of biochip Shanghai National Engineering Research Center and general manager of core super biology, led by Dr. Zhang Xiaoyan, deputy general manager of core super biology, led the R & D team, registration department, clinical trial, logistics support and other departments to work day and night. After nearly half a month of hard work, this antigen detection kit called "xinsaixin" entered the covid-19 emergency medical device approval channel of the State Food and drug administration, passed the registration inspection of the Central Inspection Institute, and completed the Chinese clinical trial.
According to reports, "xinsaixin" covid-19 antigen detection kit includes sampling swab, sampling tube (including lysate), detection card, biological hazard bag, etc. it can be used for personal home self-test. It has been verified by a large number of samples outside China and has excellent sensitivity and specificity.
The principles of antigen detection and nucleic acid detection are different. In short, nucleic acid detection adopts the principle of molecular biology. Reverse transcription, amplification and qualitative detection of nucleic acid sequences of pathogens have high sensitivity, specificity and cost. Antigen detection adopts the principle of immunology, which can complete the detection quickly in non laboratory environment. The sensitivity and specificity are worse than nucleic acid detection. Therefore, antigen detection can be used as a supplementary means of nucleic acid detection.
Gao Hengjun introduced that covid-19 antigen detection has been used in some countries for more than two years. Practice has proved that the antigen detection sensitivity is very high for patients with fever, cough and other symptoms. This is completely consistent with the characteristic that antigen products are easier to detect when the virus is highly infectious.
