Ortho Collaborates with BARDA to Accelerate Development of High Specificity SARS-CoV-2 Antibody Tests

Ortho Clinical Diagnostics (Raritan, NJ, USA) is collaborating with Biomedical Advanced Research and Development Authority (BARDA) to further advance the development of the company's SARS-CoV-2 total and IgG antibody tests.

The collaboration is a part of ongoing COVID-19 medical countermeasure development efforts by BARDA, a component of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and the federal government. BARDA has awarded Ortho USD 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 US 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. 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 US. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.

"Ortho is proud to produce high-quality, reliable tests with 100% specificity that provide patients with results they can trust as we continue to learn more about COVID-19," said Chris Smith, chief executive officer, Ortho Clinical Diagnostics. "We are unwavering in our belief that every test is a life."