Ortho Clinical Diagnostics (NSDQ:OCDX) announced that it received a CE mark for its Vitros SARS-CoV-2 antigen test for COVID-19.
European approval follows the Vitros test’s initial launch in October 2020. The CE mark allows for more convenient sample collection and expanded viral transport media, according to a news release.
Personnel at hospitals, labs and other settings will now be able to use a nasal sample for the test rather than a nasopharyngeal swab specimen. Additionally, labs can now utilize three more viral transport media (VTM) options to expand options and testing capacity.
“Regions across the world are in various stages of reopening and recovering, yet there remains a great need for reliable tests that can be performed quickly and in bulk to ensure the continued safety of these ‘back-to-normal’ measures,” Ortho Clinical Diagnostics chief innovation officer Chockalingam Palaniappan said in the release. “Ortho’s customers continue to trust its COVID-19 testing solutions — including the updated antigen test — to efficiently meet the demand for accurate mass testing and fast, trusted results.”
Raritan, N.J.–based Ortho’s Vitros antibody assay received a CE mark last month for the qualitative and semi-quantitative detection of COVID-19 antibodies.