Ortho Clinical Diagnostics’ second COVID-19 antibody test—the Vitros Immunodiagnostic Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) has received CE Mark. The test offers 100% specificity.
Chris Smith, Ortho Clinical Diagnostics chief executive officer, said: "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."
Ortho's COVID-19 IgG antibody test detects the IgG antibody. It closely follows the introduction of Ortho's COVID-19 Total test. Both of Ortho's tests help healthcare professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV-2 virus.
Christopher D. Hillyer, president and CEO, New York Blood Center, said: "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."
Ortho's COVID-19 IgG antibody test received Emergency Use Authorisation 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 analysers 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 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.
The 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. The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been FDA cleared or approved. They have been authorised by the FDA under an emergency use authorisation.
