www.fdanews.com/articles/203735-scope-fluidics-covid-19-test-gets-ce-mark
Scope Fluidics’ COVID-19 Test Gets CE Mark
July 29, 2021
Scope Fluidics has received the CE mark for its PCR ONE polymerase chain reaction test for COVID-19.
The test has a 91.2 percent sensitivity in identifying those infected with the disease and 100 percent specificity in correctly identifying people without the disease, Scope Fluidics said.
Because it is designed to test for a number of targets in the SARS-CoV-2 genome, it can be adapted to pick up new variants of the virus, the company said.