Ortho Clinical Diagnostics has secured CE mark approval for its new VITROS SARS-CoV-2 antigen test for the identification of SARS-CoV-2 infection.

The firm also filed an emergency use notification and submitted an application with the US Food and Drug Administration (FDA) for emergency use authorisation (EUA) status for the VITROS SARS-CoV-2 antigen test.

With 97.8% sensitivity and 99.2% specificity, Ortho’s VITROS SARS-CoV-2 antigen test is said to serve as a viable alternative to real-time polymerase chain reaction (PCR) testing for individuals with known or suspected exposure to SARS-CoV-2 or who are showing symptoms suggestive of viral infection.

According to Ortho, it is also the first test to run on the company’s fully automated VITROS platform from swabs rather than the blood and body fluid samples generally run by the systems.

Samples for Ortho’s SARS-CoV-2 antigen test can be collected in large quantities and stored at room temperature for up to 24 hours or 48 hours if refrigerated.

The collected samples are run on Ortho’s high-throughput VITROS systems, which can process up to 130 antigen samples per hour.

The SARS-CoV-2 antigen test is designed to run on Ortho’s VITROS XT 7600 integrated system, VITROS 3600 immunodiagnostic system and VITROS 5600 integrated system.

Ortho also offers two other Covid-19 antibody tests

Ortho also offers two other Covid-19 antibody tests, including Total and IgG, which have secured FDA EUA status in April and CE mark approval in May.

In May this year, the company secured CE mark approval for its Covid-19 IgG antibody test. The company’s VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG test has been designed for the identification of IgG antibody.

Ortho produces its SARS-CoV-2 antigen test at the Rochester facility in New York. It plans to scale up the production of the test at the Pencoed facility in the UK.

Ortho Clinical Diagnostics chairman and CEO Chris Smith said: “At Ortho, we never stop innovating. As COVID-19 cases continue to rise across the globe, the world is in urgent need of highly accurate tests that detect active infection and can be processed in high volumes.

“Ortho continues to bring to market COVID-19 solutions that help labs and healthcare professionals identify, treat and ultimately contain this virus.”