Beckman Coulter secures EUA for SARS-CoV-2 test

2019 08 09 22 20 6739 Beckman Coulter Aacc 2019 400

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.

Page 1 of 10
Next Page