Roche’s COVID Antibody Test Receives FDA Authorization
(photo courtesy of Roche Diagnostics USA)
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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowThe U.S. Food and Drug Administration has issued an Emergency Use Authorization for the new COVID-19 antibody test developed by Roche Diagnostics in Indianapolis. Roche says the test is designed to help determine if someone has been exposed to the SARS-CoV-2 virus and if they’ve developed antibodies against it.
Roche says its SARS-CoV2 antibody test has high specificity which is crucial in determining if a person has been exposed to the virus and if they have developed antibodies. The company says this can help assess patients’ immune response to the virus, and as more is understood about immunity to SARS-CoV-2, the test may help assess who has built up immunity to the virus.
Roche says it is already shipping the new antibody test to leading laboratories around the world and expects to ramp up production capacity.
“Thanks to the enormous efforts of our dedicated colleagues we are now able to deliver a high-quality antibody test in high quantities, so we can support healthcare systems around the world with an important tool to better manage the COVID-19 health crisis,” said Severin Schwan, chief executive officer at Roche Group. ”I am in particular pleased about the high specificity and sensitivity of our test, which is crucial to support health care systems around the world with a reliable tool to better manage the COVID-19 health crisis.”
The company says hospitals and laboratories can run the test on Roche’s cobas e analysers, which are widely available around the world.