Ortho's Total Antibody Test for COVID-19 Secures FDA Emergency Use Authorization

Ortho Clinical Diagnostics (Raritan, N.J., USA) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its total antibody assay for COVID-19—the VITROS® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. The test is one of the first high-throughput, automated COVID-19 antibody tests to be granted EUA and follows Ortho's launch of the test under the FDA's notification pathway for serology tests on April 3.

Ortho's COVID-19 total antibody test can help determine who can responsibly be permitted to go back to work by aiding in the identification of currently infected or previously exposed individuals who may have developed immunity. The test can also help screen plasma donations for convalescent plasma therapy, which helps critically ill patients fight the virus, help medical professionals and epidemiologists better understand the spread of the disease, and is an important tool for aiding vaccine development efforts to monitor immune responsiveness. When coupled with information from a molecular test, which detects active infection, it can monitor disease progression by measuring when antibodies appear in the blood.


The tests can be run on Ortho's flagship laboratory analyzer, the VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and will soon be available on VITROS® ECi/ECiQ Immunodiagnostic Systems. Ortho will be in full production in the coming weeks and plans to manufacture several million SARS-CoV-2 antibody tests over the next month, with rapid production expansion following thereafter.

"The COVID-19 pandemic continues to impact individuals, families, and communities around the world," said Chris Smith, chief executive officer, Ortho Clinical Diagnostics. "Ortho is proud to be working toward large-scale solutions that will help people return to work, reducing the strain on both employees and the economy as a whole. Our focus on improving patients' lives through diagnostics led us to rapidly develop this test, providing the one of the key resources needed for diagnosing and treating COVID-19. We remain committed to helping laboratories deliver fast, accurate, reliable results to healthcare professionals, patients and the researchers developing the long-term, sustainable management of this disease."