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Ortho Clinical Diagnostics Brings in CE Mark for Antibody Test

The Raritan, NJ-based company’s antibody test being granted CE mark comes shortly after it received emergency use authorization from FDA. It also comes on the heels of Abbott Laboratories’ antibody test receiving positive marks from University of Washington researchers.

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Ortho Clinical Diagnostics has received CE mark for its COVID-19 total antibody test. The CE mark comes just a few weeks after the Raritan, NJ-based company was granted an emergency use authorization by FDA for the test.

The company said the 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.

The firm said the test 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.

"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," Chockalingam Palaniappan, PhD, CIO, Ortho Clinical Diagnostics, said in a release. "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, healthcare professionals, and other essential personnel working with affected populations."

The CE mark comes on the heels of Abbott Laboratories’s antibody test being evaluated by University of Washington researchers. The team found the Abbott Park, IL-based company’s test performed well.  

In the study, researchers tested 1,020 serum specimens collected prior to SARS-CoV-2 circulation in the U.S. and found one false positive, indicating specificity of 99.9%. The researchers also looked at 125 patients who tested RT-PCR positive for SARS-CoV-2 for which 689 excess serum specimens were available and found sensitivity reached 100% at day 17 after symptom onset and day 13 after PCR positivity.

The research was published in the Journal of Clinical Microbiology.


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