The U.S. Food and Drug Administration on Tuesday said it had granted Emergency Use Authorization to Ortho Clinical Diagnostics’ total antibody test for COVID-19. The test is one of the first high-throughput, automated COVID-19 antibody tests to be granted Emergency Use Authorization.
High-throughput instruments can output a large number of test results in a short period of time. When running infectious disease tests such as the COVID-19 tests, Ortho’s instruments can process up to 150 tests per hour.
“The COVID-19 pandemic continues to impact individuals, families and communities around the world,” said Chris Smith, Ortho Clinical Diagnostics CEO. “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 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.”
A limited quantity of test kits already have been shipped to high priority areas. 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 test was developed at Ortho’s Global Center of Excellence for R&D in Rochester and can be run on the company’s flagship laboratory analyzer, the VITROS T 7600 Integration System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and soon on the VITROS ECi/ECiQ Immunodiagnostic Systems, which are installed in more than 1,000 hospitals and labs in the U.S.
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