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

RARITAN, New Jersey, May 11, 2020 /PRNewswire/ -- Ortho Clinical Diagnostics, a global leader of in vitro diagnostics with a rich history of bringing critical tests for infectious diseases to market, today announced it is working with Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, to expand COVID-19 antibody testing to more than 20 Quest laboratories across the U.S.

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, among only a small number in the world to be granted Emergency Use Authorization by the U.S. 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. 

"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."

Quest offers two ways to access COVID-19 antibody testing. Healthcare providers can order testing on behalf of their patients, or individuals can initiate physician-directed testing online, without visiting a doctor's office, through QuestDirect.

Ortho currently offers two COVID-19 antibody tests. Ortho's total antibody test, granted Emergency Use Authorization 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.