Avacta’s AffiDX COVID-19 Antigen Self-Test Receives CE Mark

Cambridge, UK-based Avacta Group has received a CE mark certification for its AffiDX SARS-CoV-2 rapid antigen self-test.

The company partnered with Medusa Healthcare to secure regulatory approval for the test, which Medusa will market under the brand name MeduFlow.

The AffiDX test, which delivers a result in 20 minutes, was clinically validated at the Carlos III hospital in Madrid, Spain, where it was shown to have a sensitivity across a broad range of viral loads of 98 percent and a specificity of 99 percent.