Ortho’s Second COVID-19 Antibody Test with 100% Specificity Launched

Ortho Clinical Diagnostics (Raritan, NJ, USA) has introduced its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test).

The test is among only a handful of antibody tests to be granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). Ortho had previously received FDA EUA for its first COVID-19 total antibody test on April 14, 2020 and both the tests have 100% specificity.

Ortho's total antibody tests detect all COVID-19 related antibodies, 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. Ortho's newest test detects only the IgG antibody which appears in a patient's blood in the later phase of the infection and remains elevated even after recovery. Both of Ortho's tests help health care professionals understand if a patient has been exposed to and has developed antibodies to the COVID-19 virus.

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. VITROS Systems, already installed in more than 1,000 hospitals and reference labs in the U.S., 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 IgG antibody tests each month.

"Ortho is proud that both of our COVID-19 total and IgG tests are achieving 100% specificity," said Chris Smith, Ortho Clinical Diagnostics' Chief Executive Officer. "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."

"Both tests run 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 will allow 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."