Industry News: Ortho's COVID-19 total antibody test receives CE Mark

12 May 2020

Ortho Clinical Diagnostics has announced its COVID-19 total antibody test has received CE Mark. The test is designed to offer excellent performance, with 100% specificity and sensitivity.

Ortho’s total antibody test detects all COVID-19 related antibodies (IgA, IgM and IgG), including IgM, which appears in the early, acute stage of infection, and helps determine the onset of a patient’s immune response by monitoring all antibodies generated through disease progression. It can help health care professionals understand if a patient has been exposed to and has developed antibodies to the SARS-CoV02 virus causing COVID-19. 

The test runs 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. VITROS Systems are self-contained and do not require an external water source to run, offering labs placement flexibility. 

“Ortho’s test runs on the widely used Ortho VITROS platform and the results will paint a vivid picture of a patient’s immune response status,” said Chockalingam Palaniappan, Ph.D., chief innovation officer, Ortho Clinical Diagnostics. “Clinicians will now have invaluable information that may assist them to make decisions about the propriety of a patient returning to work. This is critical information for first responders, health care professionals and other essential personnel working with affected populations.”

Ortho plans to manufacture several million COVID-19 total antibody tests each month in Rochester, New York and Pencoed, Wales. 

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