CE mark

Orthos Gains CE Mark for COVID-19 Antigen Test

October 28, 2020

Orthos Clinical Diagnostics’ Vitros SARS-CoV-2 high-throughput antigen test has earned a CE mark certification.

With a 97.8 percent sensitivity and 99.2 percent specificity, the test offers “a viable alternative” to real-time polymerase chain reaction testing for individuals with known or suspected exposure to SARS-CoV-2 or who are displaying symptoms suggestive of viral infection, the company said.

The antigen test runs on Orthos’ Vitros platform, using samples that can be stored at room temperature for up to 48 hours, according to Orthos.

The company has also applied for an Emergency Use Authorization from the FDA.

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