Ortho's VITROS SARS-CoV-2 Antigen Test Becomes First High-Volume COVID-19 Antigen Test to Receive FDA EUA

Ortho Clinical Diagnostics’ (Raritan, NJ, USA) VITROS SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive US Food and Drug Administration (FDA) Emergency Use Authorization (EUA).

Ortho's COVID-19 antigen test is an alternative to real-time polymerase chain reaction (PCR) testing, which although highly sensitive, can be expensive and require long processing times during testing surges. Other COVID-19 diagnostic testing platforms, including rapid antigen tests, have limited capacity to run multiple tests simultaneously or require short time windows to read results, making it challenging to test more than a handful of patients at a time. With utility for mass-scale testing and same-day results for labs, Ortho's latest COVID-19 solution can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results.


The VITROS SARS-CoV-2 Antigen Test produces accurate, clinically reliable results on Ortho's high-volume VITROS Systems, which are installed in over 5,600 laboratories around the world. These analyzers normally run a broad menu of over 150 different tests from blood and body fluid samples, but now are also able to run samples derived from swabs.

"As the pandemic continues to devastate our communities and economy, laboratory professionals have been working under extraordinary circumstances to deliver critical COVID-19 testing data to patients, clinicians and communities," said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. "Even as vaccine inoculation programs roll out, mass-scale testing remains an essential tool in fighting COVID-19. Ortho's accurate, high-volume COVID-19 antigen test can play a pivotal role in the global response to this virus."