FDAnews
www.fdanews.com/articles/200599-beronis-covid-19-antigen-test-kit-gets-european-clearance
ClearanceStamp_Blue.gif

Beroni’s COVID-19 Antigen Test Kit Gets European Clearance

December 23, 2020

The Beroni Group has earned a CE mark in Europe for its SARS-CoV-2 antigen test kit that uses a colloidal gold method — the suspension of gold nanoparticles in a liquid to improve the sensitivity of optical sensors.

The test analyzes nasopharyngeal swab samples to identify patients with the SARS-CoV-2 virus that causes COVID-19 infections, even if the patients are asymptomatic, and it can deliver results in 10 minutes.

Beroni previously released a blood-based antibody test kit for the SARS-CoV-2 virus but said the new antigen test is “another significant milestone.”

Incorporated in Australia in 2016, Beroni has its origins in China’s Tianjin Beroni Biotechnology, which was established in 2014. The group’s main business is the development and sale of healthcare-related products.

View today's stories