On December 21, 2020, Australia, Beroni Group Limited (“Beroni Group”) announces it has received notification from its European Authorized Representative, CMC Medical Devices & Drugs SL, that its newly developed SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) complies with the applicable essential requirements of the European Parliament and of the Council’s directive 98/79/EEC on in vitro diagnostics as amended, and has received CE certification.
The SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) is the latest product of Beroni Group to detect the novel coronavirus. Compared with SARS-CoV-2 IgG/IgM Antibody Detection Kit, the new product 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. The kit is used for qualitative assays of SARS-CoV-2 antigen samples in vitro for professional use.
At present, Beroni Group’s SARS-CoV-2 IgG/IgM Antibody Detection Kit has been exported to Britain, Japan and other countries. The launched new product SARS-CoV-2 Antigen Test Kit is another significant milestone in our ongoing efforts to develop diagnostic tools for rapid detection of the COVID-19 virus.
