Ortho receives CE mark for COVID-19 IgG antibody test

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced its second COVID-19 antibody test—the VITROS^® Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) received CE Mark. The test offers 100% specificity.

The observed 100% specificity with Ortho's VITROS SARS-CoV-2 tests allows an extremely high level of confidence so that people will not be identified as having an immune response to the virus when in fact they do not. Statistically, the chance of error rises dramatically even with a very small decline from 100% in specificity, given our understanding of the prevalence of the COVID-19 virus today."

Christopher D. Hillyer, MD, President and CEO, New York Blood Center

Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity. During this health crisis, good is simply not good enough. This high level of specificity is a testament to Ortho's strong belief that every test is a life."

Chris Smith, Chief Executive Officer, Ortho Clinical Diagnostics

Ortho's COVID-19 IgG antibody test detects the IgG antibody. It closely follows the introduction of Ortho's COVID-19 Total test and the two tests offer greater choice in tracking and surveillance, patient management, and screening convalescent plasma. 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.

Ortho's COVID-19 IgG antibody test received Emergency Use Authorization from the U.S. Food and Drug FDA administration on April 24, 2020. Ortho's total antibody test received CE Mark on May 8, 2020 and FDA Emergency Use Authorization on April 14, 2020.

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 will soon be available on VITROS^® ECi/ECiQ Immunodiagnostic Systems. Ortho has over 5,600 Immunodiagnostic systems installed around the world. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility.

Ortho is manufacturing the COVID-19 IgG antibody tests at its Pencoed, U.K., facility. It plans to manufacture several million tests in the coming weeks.

Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: [email protected].