NEW YORK ─ Ortho Clinical Diagnostics said Tuesday evening that the US Food and Drug Administration has granted Emergency Use Authorization for its Vitros Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators.
The total antibody assay is one of the first high-throughput, automated antibody tests for the coronavirus to be granted an EUA and can process up to 150 tests per hour, Ortho said. To date, tests from Chembio Diagnostics and Cellex are the only other serology SARS-CoV-2 tests to receive FDA EUA.
Ortho said it launched its test on April 3 under the FDA’s notification pathway for serology tests and has shipped a limited quantity to areas of highest priority. It anticipates reaching 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.
Raritan, New Jersey-based Ortho said its test systems are installed in more than 1,000 hospitals and reference laboratories in the US. The antibody tests can be run on its Vitros XT 7600 Integrated System, Vitros 3600 Immunodiagnostic System, and Vitros 5600 Integrated System, and it will soon be available for use with the Vitros ECi/ECiQ Immunodiagnostic Systems.
When coupled with information from a molecular test, which detects active infection, the antibody test can monitor disease progression by measuring when antibodies appear in the blood, Ortho said. Its total antibody test can identify people who are currently infected or were previously exposed to the coronavirus and may have developed immunity, and the test can be used to help determine who can be responsibly permitted to go back to work, the firm added.
The test can also help screen plasma donations for convalescent plasma therapy, which helps critically ill patients fight the virus and helps medical professionals and epidemiologists to better understand the spread of the disease. The test could also be used as a tool to aid vaccine development to monitor immune responsiveness, Ortho said.