Beckman Coulter nabs EUA for COVID-19 IgM assay

By LabPulse.com staff writers

October 9, 2020 -- 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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Beckman Coulter has released its Access SARS-CoV-2 Immunoglobulin M assay, a new antibody test for the novel coronavirus. The assay targets antibodies...
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Beckman Coulter secures EUA for SARS-CoV-2 test
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...
Beckman Coulter's SARS-CoV-2 IgG assay hits CE Mark countries
Beckman Coulter announced its Access SARS-CoV-2 immunoglobulin G (IgG) assay is now available in markets that accept the CE Mark.

Copyright © 2020 LabPulse.com

Last Updated ls 10/9/2020 3:48:02 PM



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