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Ortho Clinical Diagnostics Gets CE Mark for High-Throughput SARS-CoV-2 Antigen Test

NEW YORK ─ Ortho Clinical Diagnostics on Monday announced it has received the CE mark for an antigen test to detect active SARS-CoV-2 infection, enabling its use in Europe and other countries that accept such designation.

The Raritan, New Jersey-based diagnostics company said it has also submitted an Emergency Use Authorization request to the US Food and Drug Administration for its Vitros SARS-CoV-2 Antigen test.

Ortho added that the antigen test is the first to run on its high-throughput, fully automated Vitros testing platform from swabs rather than blood and body fluid samples.

Samples for the SARS-CoV-2 antigen test can be collected in bulk, stored at room temperature for up to 24 hours or 48 hours if refrigerated, and run on Ortho’s high-throughput Vitros systems, which are capable of processing up to 130 antigen samples per hour, the firm said. 

Ortho said that its antigen test is a viable alternative to RT-PCR for people with known or suspected exposure to SARS-CoV-2 or who are displaying symptoms suggestive of viral infection.

With 97.8 percent sensitivity and 99.2 percent specificity, the test "offers exceptional utility for mass-scale testing where appropriate," the company said in a statement.

The firm already also has two COVID-19 antibody tests on the market. One detects total antibodies to SARS-CoV-2 and the other detects IgG antibodies, and both have received CE marking and FDA EUA.

Ortho recently was awarded almost $12.9 million by the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop its SARS-CoV-2 antigen test and to further develop its two SARS-CoV-2 antibody tests currently authorized for emergency use.

Ortho said it manufactures its SARS-CoV-2 antigen test in Rochester, New York, and will soon scale up production in Pencoed, UK. The test will be available worldwide in large volumes beginning in early November.