Now Ortho’s COVID Antibody Test Gains CE Mark

CE mark for Ortho Covid 19 Antibody Test

Ortho Clinical Diagnostics, a global leader of in vitro diagnostics has announced that its COVID-19 total antibody test received CE Mark. Ortho says the test offers excellent performance, with 100 percent specificity and sensitivity.

Background

Ortho’s COVID-19 total antibody test is designed and solely intended to be performed by laboratory professionals. The company launched the test to market in the U.S. on April 3, 2020 and received U.S. FDA Emergency Use Authorization on April 14, 2020.

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

Company comments

“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.”

Source: PR Newswire

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