High-Volume COVID Antigen Test Receives FDA EUA

Ortho Clinical Diagnostics’ VITROS SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
 
U.S. distribution of the test commenced in November 2020 under an FDA Emergency Use Notification (EUN); the test was also granted CE Mark in November 2020. 
 
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. Roughly one-third of individuals who underwent a PCR test waited more than four days for a result—including 10 percent who waited more than 10 days, according to an article published by researchers from Harvard, Northeastern, Northwestern, and Rutgers.¹
 
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.
 
Ortho says it is currently able to deliver 5 million tests per month and can scale up to 15 million tests per month in February.
 
Increasing Testing Capacity
Ortho’s antigen test comes at a critical time. A recent Rockefeller Foundation report estimates that the U.S. will need to increase coronavirus testing capacity by nearly 10-fold — from 21 million to 193 million tests per month — in order to reopen schools safely and protect nursing homes. 
 
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. 
 
“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.” 
 
The test is run on Ortho’s high-volume VITROS Systems, which are installed in over 5,600 laboratories around the world with 1,500 installed in the U.S. Through this authorization, Ortho expects to increase delivery from its current rate of 5 million tests per month to 15 million by February.
 
Reference:
¹ Lazer, David. The COVID-19 Consortium for Understanding the Public’s Policy Preferences Across States. Northeastern University, Harvard University, Rutgers University, and Northwestern University, covidstates.net/COVID19%20CONSORTIUM%20REPORT%208%20TEST%20JULY%202020.pdf.