Ortho Launches New VITROS SARS-CoV-2 Antigen Test for Accurate Mass-Scale Testing in Markets Accepting 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).

Ortho’s COVID-19 IgG antibody test detects the IgG antibody and offers 100% specificity. 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. 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’s COVID-19 IgG antibody test received Emergency Use Authorization from the US Food and Drug FDA administration in April this year. The company’s total antibody test received CE Mark in May and FDA Emergency Use Authorization in April 2020. Ortho is manufacturing the COVID-19 IgG antibody tests at its UK facility and plans to manufacture several million tests in the coming weeks.

“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.”

“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.”