North American Diagnostics’ COVID-19 Antigen Test Earns CE Mark

Daytona Beach, Fla.-based North American Diagnostics’ oral rapid antigen test for COVID-19 has received CE mark certification.

The point-of-care SARS-CoV-2 Rapid Test, which is for use in both symptomatic and asymptomatic patients, returns results in 20 minutes and has demonstrated sensitivity of 97 percent and specificity of 100 percent in two clinical trials, the company said.

North American Diagnostics plans to file for Emergency Use Authorization from the FDA after it completes supplemental clinical trials of the test.