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FDA approves Roche test that detects antibodies that fight coronavirus

By Don Jacobson
FDA approves Roche test that detects antibodies that fight coronavirus
Roche said its test works by detecting antibodies in the body's immune system that fight the virus' spike protein "crown." File Photo by Steffen Schmidt/EPA-EFE

Dec. 2 (UPI) -- Federal regulators have given emergency approval for a new blood test that can measure antibodies in people who have been exposed to the novel coronavirus that causes COVID-19.

The Food and Drug Administration granted emergency use authorization Tuesday for the Elecsys Anti-SARS-CoV-2 S antibody test, manufactured by Swiss pharmaceutical and diagnostics company Roche.

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The manufacturer said the test works by detecting antibodies sent by the body's immune system to fight the coronavirus spike protein "crown."

Several vaccines in development use genetic information to activate an antibody response against the spike protein. So, Roche said, a test is needed to measure that response over time.

"Antibody tests like these will play a critical role in measuring a person's vaccine-induced immune response, and supporting the development of convalescent plasma therapy to help other patients fight the disease," Roche Diagnostics CEO Matt Sause said in a statement.

Roche's antibody test received European Union approvals in September. The company said it will begin shipping kits to U.S. laboratories next week, with the first going to national diagnostics firm LabCorp.

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