Ortho Clinical Diagnostics, an in vitro diagnostics company, announced it is collaborating with the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to further advance the development of the company’s SARS-CoV-2 total and IgG antibody tests as part of BARDA’s and the federal government’s ongoing COVID-19 medical countermeasure development efforts. BARDA has awarded Ortho $678,000 in support of the company’s COVID-19 antibody testing program.
Ortho manufactures two SARS-CoV-2 antibody tests—total and IgG—which were granted Emergency Use Authorization by the U.S. Food & Drug Administration in April.
Ortho’s total antibody test detects all COVID-19 related antibodies (IgA, IgM and IgG) and Ortho’s COVID-19 IgG antibody test detects the IgG antibody, which appears in a patient’s blood in the later phase of the infection and remains elevated even after recovery. The tests offer greater choice in tracking, surveillance and patient management. As noted on the U.S. Food and Drug Administration’s website, test results also can help aid in determining who may be eligible to donate a part of their blood called convalescent plasma, which may serve as a possible treatment for those who are seriously ill from COVID-19. Both of Ortho’s tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.
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. Ortho has over 5,600 Immunodiagnostic systems installed around the world, with more than 1,000 already installed in hospital and reference labs throughout the United States. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.
