Beroni Group announced that it has received notification from its European Authorized Representative, CMC Medical Devices & Drugs SL, that its newly developed SARS-CoV-2 Antigen Test Kit complies with the applicable essential requirements of the council directive 98/79/EEC in vitro diagnostics as amended. Based on Beroni’s SARS-CoV-2 IgG/IgM Antibody Detection Kit, the SARS-CoV-2 Antigen Test Kit optimizes the sample collection process. It requires no blood, and only a nasopharyngeal swab is needed to collect samples. This greatly improves the convenience of testing and the test results can be obtained within 10 minutes. This antigen test kit was prepared using colloidal gold solid-phase immunochromatography. A monoclonal antibody SARS-CoV-2 was pre immobilized on the cellulose nitrate membrane. The monoclonal antibody against the core protein of SARS-CoV-2 was labeled on colloidal gold on the glass fiber membrane. The double antibody sandwich immunoassay was used to detect the monoclonal antibody against the core protein of the SARS-CoV-2. The kit is used for qualitative assays of SARS-COV-2 antigen samples in vitro for professional use.