Roche Wins Emergency Approval for its COVID-19 Antibody Test

Testing blood serum

The U.S. Food and Drug Administration (FDA) green-lit Roche’s new Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus that has swept across the globe and developed antibodies to the disease.

The Elecsys Anti-SARS-CoV-2 immunoassay is an in vitro test, which uses human serum and plasma drawn from a blood sample to detect antibodies and determine the body’s immune reaction to SARS-CoV-2. The FDA gave the nod to the serology test that Roche said has a specificity greater than 99.8% and sensitivity of 100% at two weeks following PCR confirmation. It was approved under Emergency Use Authorization (EUA). That high specificity for SARS-CoV-2 should mean that few false-positive results will appear, particularly if the individual has antibodies for other coronaviruses. The high specificity of the test is crucial to determine reliably if a person has been exposed to the virus and if the patient has developed antibodies, Roche said in its announcement.

Roche is ramping up production and has already begun to ship the new antibody test to laboratories in the United States and Europe, where it also received emergency approval. The company believes it can deliver tens of millions of tests per month.

Severin Schwan, Roche’s chief executive officer, said the new antibody test will support healthcare systems across the globe in the battle against the pandemic. He touted the high specificity and sensitivity of the test, which Schwan said is “crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.” As researchers learn more about potential immunity to COVID-19, the company believes the test may help to assess who has built up any immunity to the virus, which is a key concern as governments begin to initiate efforts to loosen stay-at-home orders in hopes of re-energizing stagnant economies. It is important to note that at this time, it is unknown what kind of immunity to COVID-19 the presence of antibodies will provide.

“Our best scientists have worked 24/7 over the last few weeks and months to develop a highly reliable antibody test to help fight this pandemic,” Thomas Schinecker, CEO of Roche Diagnostics said in a statement. “Roche is committed to helping laboratories deliver fast, accurate, and reliable results to healthcare professionals and their patients.”

The new antibody test is available on Roche’s cobas e analysers which are widely used in hospitals and labs around the world. The approval of its Elecsys test follows EUA of its cobas SARS-CoV-2 Test for the presence of the virus in the body, which won approval in March.

Roche’s test joins a number of other antibody tests that have recently come on the market. Earlier this month the U.S. Food and Drug Administration approved the first blood test for COVID-19 antibodies. Research Triangle Park, N.C.-based Cellex was granted an EUA for its test. The FDA approved Ortho Clinical Diagnostics’ VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrators, a high-throughput, automated COVID-19 antibody test. Abbott Laboratories has also launched an antibody test. Abbott's SARS-CoV-2 IgG test identifies the IgG antibody, which is a protein that the body produces in the late stages of infection.

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