The antigen test is the first to run on Ortho's fully automated VITROS platform from swabs
FDA accepts Emergency Use Notification for VITROS test (Credit: PIRO4D from Pixabay.)
The US Food and Drug Administration (FDA) has accepted Ortho Clinical Diagnostics’ Emergency Use Notification (EUN) for its new VITROS SARS-CoV-2 Antigen test, to detect active SARS-CoV-2 infection.
The in vitro diagnostics company has filed an Emergency Use Authorization (EUA) application with the US FDA on 23 October 2020.
The company has previously obtained CE Mark approval to market the diagnostic test across the European Union (EU).
Ortho said that its VITROS SARS-CoV-2 antigen test, offering high sensitivity and specificity, will facilitates enhanced utility for mass-scale testing.
Also, the test is a feasible alternative to real-time polymerase chain reaction (PCR) testing for people with suspected SARS-CoV-2 infection or with symptoms of infection.
Ortho Clinical Diagnostics chairman and chief executive officer Chris Smith said: “At Ortho, we never stop innovating.
“As Covid-19 cases continue to rise across the globe, Ortho is working to bring to market Covid-19 solutions that help labs meet an ever-growing testing demand and best serve their communities with high-quality, accurate, cost-effective tests that run at high volumes.”
Ortho’s new SARS-CoV-2 antigen test runs on hight-throughput VITROS System
The VITROS SARS-CoV-2 Antigen test adds to the company’s Covid-19 testing solutions, including Total and IgG, which received FDA Emergency Use Authorization in April 2020, and CE Mark in May 2020.
Ortho has designed the new SARS-CoV-2 antigen test for use on its VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, and the VITROS 5600 Integrated System.
The antigen test is the first to run on Ortho’s fully automated VITROS platform from swabs, instead of the typical blood and body fluid samples used by the systems.
The test run on Ortho’s high-throughput VITROS Systems, which are capable of processing up to 130 antigen samples per hour, while PCR tests take hours to obtain results.
Also, the samples for new SARS-CoV-2 antigen test can be collected in bulk, stored for up to 24 hours at room temperature or 48 hours if refrigerated.
Ortho is manufacturing its new SARS-CoV-2 antigen test in Rochester, New York, and intends to scale up production in Pencoed, UK.