Beckman Coulter nabs EUA for COVID-19 IgM assay

2019 08 20 21 56 4830 Beckman Coulter Aacc 2019 400

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Beckman Coulter's Access SARS-CoV-2 immunoglobulin M (IgM) assay, which detects antibodies that recognize the receptor-binding domain (RBD) of the spike protein on the virus.

The Access SARS-CoV-2 IgM assay has 99.9% specificity and 98.3% sensitivity, according to Beckman Coulter.

The firm is also developing a SARS CoV-2 antigen assay as well as a quantitative IgG assay that it anticipates will be launched later this year.

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