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Antibody test that offers ‘100% specificity and sensitivity’ receives CE mark

Antibody test that offers ‘100% specificity and sensitivity’ receives CE mark

In vitro diagnostics firm Ortho Clinical, has received the CE mark for its COVID-19 total antibody test. The company says the test offers 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.

The test runs on Ortho’s high-throughput, fully automated analysers including its 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. 

Chockalingam Palaniappan, chief innovation officer, Ortho Clinical Diagnostics, said: “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. 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. 

Ortho’s COVID-19 total antibody test is 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 has been authorised by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 to perform moderate and high complexity tests. The test has been authorised only for the detection of total antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis.

Med-Tech Innovation

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