Ortho Clinical Diagnostics announced the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to its second COVID-19 antibody test—the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test). This test is one of only a handful of antibody tests to be granted Emergency Use Authorization.
Ortho previously received FDA Emergency Use Authorization for its COVID-19 total antibody test on April 14, 2020. Of note, both tests have 100 percent specificity.
Ortho’s total antibody test’s launch to market in the U.S. was announced on April 3, 2020. It detects 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.
