FDA’s Convalescent Plasma EUA Requires All Donor Blood Units be Tested Only with Ortho’s COVID-19 IgG Antibody Test

Raritan, NJ

In its August 23 Emergency Use Authorization (EUA) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19, the U.S. Food and Drug Administration (FDA) requires all units of donor blood to be tested on Ortho Clinical Diagnostics’ VITROS® Anti-SARS-CoV-2 IgG test for anti SARS-CoV-2 antibodies as a manufacturing step before release to hospitals and patients.*

The EUA was based in part on data from the FDA’s Expanded Access Program (EAP), run by the Mayo Clinic.

“COVID-19 convalescent plasma is a promising therapy that the FDA has reason to believe demonstrates clinical benefit in hospitalized patients treated early and with higher antibody levels,” said Mike Iskra, executive vice president, Commercial Excellence and Strategy, Ortho Clinical Diagnostics. “Ortho is pleased to offer a broadly available, high-throughput, low-cost test that can help health care teams identify convalescent plasma to aid the most critically ill patients. Because Every Test is a Life,™ we will continue to and continue to work to deliver large-scale solutions to help identify, control, and treat this devastating virus.”

Ortho’s COVID-19 IgG antibody test runs on Ortho’s VITROS® systems, already installed in more than 1,000 hospitals and reference labs throughout the United States. When running infectious disease tests such as our COVID-19 tests, Ortho’s instruments can process up to 150 tests per hour.

The new COVID-19 convalescent plasma EUA is a groundbreaking announcement and Ortho is proud to have product offerings that are key in the major advancements being made by the scientific and medical communities to assure patients are able to access critical therapies in the continued fight against this unprecedented virus. 

Ortho manufactures its COVID-19 IgG antibody test in Rochester, New York and Pencoed, UK and produces millions of tests per week. 

Questions from laboratories, healthcare providers, or government officials regarding the COVID-19 antibody test can be directed to: OrthoCOVID19Test@orthoclinicaldiagnostics.com. 

The VITROS Anti-SARS-CoV-2 IgG test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization and testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate and high complexity tests. The test has been authorized only for the detection of IgG antibodies from SARS-CoV-2, not for any other viruses or pathogens, and results should not be used as the sole basis for diagnosis. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

*If a blood establishment is considering using an alternative test in manufacturing for convalescent plasma release, they should contact the FDA Center for Biologics Evaluation and Research (CBER) to determine acceptability of the proposed test, which if accepted, would require an amendment to the newly issued EU.