Features of Production Process and Risk Prevention and Control Points of Corona Virus Disease 2019 (2019-nCoV) Antigen Detection Reagent (Colloidal Gold Method)

Corona Virus Disease 2019 (2019-nCoV) antigen detection reagent (colloidal gold method) has been applied to people who go to basic medical and health institutions for medical treatment and have respiratory tract, fever and other symptoms within 5 days, isolate observers, community residents who need antigen self-testing. The wide application of the reagent can effectively shorten the detection time, reduce the detection cost and time cost, and alleviate the pressure of nucleic acid detection. The article details the structural components, testing principles, production process and key risk points of the new coronavirus antigen test reagents, with the aim of providing a reference for the development of relevant work specifications for manufacturers, the organization of safe production and the verification and supervision of regulatory authorities.