Ortho Clinical Diagnostics announced its continued collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, in a new contract as part of BARDA’s and the federal government’s ongoing COVID-19 medical countermeasure development efforts, according to a press release.
BARDA awarded Ortho $12,850,000 to support the development of the company’s SARS-CoV-2 antigen test, a diagnostic test designed for the rapid detection of the virus that causes COVID-19 and continued regulatory pathway support for Ortho’s total and IgG antibody tests. Ortho manufactures two SARS-CoV-2 antibody tests—total and IgG—which were granted Emergency Use Authorization (EUA) by the U.S. Food & Drug Administration (FDA) in April.
The tests run on Ortho’s high-throughput, fully automated analyzers including its flagship VITROS XT 7600 Integrated System, the VITROS 3600 Immunodiagnostic System, the VITROS 5600 Integrated System and VITROS ECi/ECiQ Immunodiagnostic Systems. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.
The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests. The VITROS Antibody tests have been authorized only for the detection of either Total or IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis.
