FDA grants Emergency Use Authorization to Ortho’s COVID-19 total antibody test

The U.S. Food and Drug Administration (FDA) today announced it granted Emergency Use Authorization to Ortho Clinical Diagnostics' total antibody assay for COVID-19—the VITROS^® Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators. This test is one of the first high-throughput, automated COVID-19 antibody tests to be granted Emergency Use Authorization.

Across the globe, health care professionals, researchers, and government officials are racing to find solutions to better manage COVID-19 and prevent it from impacting additional lives. 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 COVID-19 pandemic continues to impact individuals, families, and communities around the world. 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."

Chris Smith, chief executive officer, Ortho Clinical Diagnostics

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. VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the U.S., are self-contained and do not require an external water source to run, offering labs placement flexibility.

A limited quantity of tests kits have already been shipped to areas of highest priority. 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.

Following Ortho's April 3 launch of the test under the FDA's notification pathway for serology tests, Ortho further worked with the FDA to secure additional review of the data under its Emergency Use Authorization pathway, which allows the FDA to expedite review and authorization of SARS-CoV-2 diagnostic tests to rapidly expand testing capacity during the COVID-19 public health emergency.

The VITROS^® Anti-SARS-CoV-2 antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use.

Questions from laboratories, healthcare providers, government, or media regarding the COVID-19 antibody test can be directed to: [email protected].