Ortho's COVID-19 IgG Antibody Test Receives CE Mark

Ortho Clinical Diagnostics (Raritan, NJ, USA) has received CE Mark for its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test which offers 100% specificity.

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 had received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) on April 24, 2020, while its total antibody test received CE Mark on May 8, 2020 and FDA EUA 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 plans to manufacture several million COVID-19 IgG antibody tests in the coming weeks.

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

"Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity," said Chris Smith, Ortho Clinical Diagnostics' Chief Executive Officer. "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."