In April 13th, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) announced that New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method), which was independently developed by the company's Fosun diagnostic technology (Shanghai) Co., Ltd. (Fosun diagnostics), was approved by the State Drug Administration ("State Administration of drug administration").
It is reported that the New Coronavirus (2019-nCoV) antigen detection kit (colloidal gold method) is used to qualitatively detect the Nucleocapsid (N) antigen of New Coronavirus (2019-nCoV) in nasal swabs samples in vitro. It can be used for the qualitative detection of New Coronavirus N antigen in nasal swabs of patients who have respiratory symptoms, fever and other related symptoms within 7 days, isolated observers and other people with antigen detection needs. Fosun diagnostic antigen detection kit has high sensitivity, specificity and strong anti-interference ability, and has no cross reaction with a variety of viruses and bacteria. The operation of the kit is simple and fast. The test results can be obtained in 15 minutes. There are various specifications of reagents. It can be used flexibly. It can be tested on demand and has low requirements for the test environment.
Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) said that the product had passed the EU CE certification, completed the German bfarm registration and was listed in the EU health and Safety Commission HSC common list. In the near future, the State Council has decided to add the antigen test as a supplement to the New Coronavirus disease prevention and control mechanism integrated group on the basis of nucleic acid detection, and has formulated the "COVID-19 virus antigen detection application plan (Trial Implementation)". After the Fosun diagnostic covid-19 virus antigen detection kit is approved for marketing, it will serve the needs of covid-19 epidemic prevention and control.
