SARS-CoV-2 Antigen Test Kit Receives CE Certification

Beroni Group 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 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 (Colloidal Gold Method) optimizes the sample collection process. It requires no blood, and only a nasopharyngeal swab is needed to collect samples. 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.

“Beroni is committed to providing protection and detection of the Covid-19 virus. At present, Beroni SARS-CoV-2 IgG/IgM Antibody Detection Kit has been exported to Britain, Japan and other countries. This new product is another significant milestone in our fight against the epidemic. We plan to distribute it to the European countries and other markets,” said Jacky Zhang, Chairman and CEO of Beroni Group. “People may never know they had Covid-19 with mild or even no symptoms. But Beroni’s SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) can let testers know whether they have the antigen. This can help them prepare for vaccination.”