Ortho Clinical’s Second COVID-19 Antibody Test Receives CE Mark

Ortho Clinical Diagnostics, a global developer of in-vitro diagnostics with a 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 percent specificity.
 
“The observed 100 percent 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, M.D., president and CEO, New York Blood Center. “Statistically, the chance of error rises dramatically even with a very small decline from 100 percent in specificity, given our understanding of the prevalence of the COVID-19 virus today.”
 
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 Administration (FDA) on April 24. Ortho’s total antibody test received CE Mark on May 8 and FDA Emergency Use Authorization on April 14.
 
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.

“Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100 percent specificity,” said Chris Smith, Ortho Clinical Diagnostics’ CEO. “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 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.
 
The VITROS Anti-SARS-CoV-2 Total and IgG tests have not been cleared or approved by the FDA. 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.