Ortho Clinical Diagnostics and Quest Diagnostics to broaden availability of COVID-19 antibody testing

May 12, 2020

Ortho Clinical Diagnostics has announced it is working with Quest Diagnostics 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 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 percent specificity, which helps prevent false positives.

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 (EUA) 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 EUA 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 U.S, are self-contained and do not require an external water source to run, offering labs placement flexibility.

Ortho began shipping its antibody tests 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 Diagnostics and other laboratory providers.

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