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CE mark

Ortho Clinical Diagnostics’ COVID-19 Antigen Tests Gets CE Mark

April 15, 2021

Ortho Clinical Diagnostics has received CE mark certification for its Vitros SARS-CoV-2 antigen test.

The test is designed for high-volume testing and is now cleared for use with nasal swabs after receiving European clearance in October 2020 for use with nasopharyngeal swabs. The test can be processed at a rate of up to 130 tests per hour using a single analyzer and is capable of delivering same-day results.

The antigen test can be used for patients suspected of COVID-19 infection within seven days of the onset of symptoms.

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