NEW YORK – New South Wales, Australia-based Beroni said Friday it has received CE certification for its SARS-CoV-2 IgG/IgM Antibody Detection Kit.
Based on colloidal gold, the rapid single-use immunochromatographic test is used to detect IgG and IgM proteins from the SARS-CoV-2 virus in capillary fingerstick whole-blood, plasma, and serum samples.
The point-of-care test kit, intended for professional use, delivers clinical results within 10 minutes, Beroni said.
Jacky Zhang, chairman and CEO of Beroni, said in a statement that the company wants to make its test kit available in European Union countries and other markets as soon as possible.
The company said it is commencing discussions with potential distributors.