Beckman Coulter secures EUA for SARS-CoV-2 test

By staff writers

June 29, 2020 -- Beckman Coulter has secured an emergency use authorization (EUA) from the U.S. Food and Drug Administration for its SARS-CoV-2 immunoglobulin G antibody test.

The company said that is able to offer 30 million tests per month in all countries that accept the EUA and the CE Mark, and has already distributed tests to 400 hospitals, clinics, and laboratories in the U.S. The test, which targets antibodies that recognize the receptor binding domain of the spike protein that SARS-CoV-2 uses to bind to a human cell receptor, has 100% sensitivity and 99.6% specificity, according to the firm.

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Last Updated eh 6/29/2020 11:13:19 AM

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