BARDA and Ortho Collaborate to Advance Development of High Specificity SARS-CoV-2 Antibody Tests

Raritan, NJ

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced it is collaborating with 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 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.

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. 

Ortho manufactures its antibody tests in Rochester, New York and Pencoed UK and are producing millions of tests per week. 

Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. For more information on BARDA visit BARDA’s COVID-19 Portfolio. 

Ortho’s antibody tests are designed and solely intended to be performed by laboratory professionals and cannot be directly used by patients as they are not for home use. Patients should consult with their health care provider to discuss antibody testing and back-to-work options. 

This project has been funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00123. 

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), 42 U.S.C. §263a, 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. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.