Ortho Clinical and Quest Diagnostics to Broaden Availability of COVID-19 Antibody Testing

Quest will use Ortho’s VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Test (COVID-19 IgG antibody test) to test patients for detectable levels of SARS-CoV-2 antibodies, which are generated by the body in response to infection. Ortho’s test, which has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration, can be used as an aid in identifying patients with an immune response, indicating recent or prior infection, and may provide helpful information regarding decisions for getting people back to work. Individuals may have the virus for weeks after developing antibodies. The test offers 100% specificity, which helps prevent false positives.

Ortho currently offers two COVID-19 antibody tests. Ortho’s total antibody test, granted EUA in on April 14, 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 COVID-19 IgG test, granted Emergency Use Authorization on April 24, 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 SARS-CoV-2 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 US, are self-contained and do not require an external water source to run, offering labs placement flexibility. The company began shipping its antibody tests weeks ago to hotspot areas with highest priority and continues to ramp up its production. Ortho plans to manufacture several million COVID-19 IgG antibody tests each month for Quest and other laboratory providers.

“Together with Quest, Ortho Clinical Diagnostics is pleased to make available a high quality, large-scale COVID-19 testing solution to quickly reach millions of Americans,” said Michael S. Iskra, president, North America Commercial Operations, Ortho Clinical Diagnostics. “100% specificity highlights the accuracy of Ortho’s antibody test. In this widespread health crisis, Ortho strongly believes that every test is a life and is proud to join with Quest in the fight against coronavirus.”

“Antibody testing can play an important role in helping individuals understand if they’ve been exposed to the virus that causes COVID-19 and may have mounted an immune response,” said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. “Through our relationship with Ortho Clinical Diagnostics, we are broadening the range of high quality COVID-19 antibody test platforms we use in our laboratories to serve growing demand.”