Research & Development
Beckman Coulter's SARS-CoV-2 IgG antibody test wins FDA's EUA
30 June 2020 -

Healthcare company Beckman Coulter reported on Monday the receipt of Emergency Use Authorization (EUA) from the US Food & Drug Administration (FDA) for its Access SARS-CoV-2 IgG antibody test.

SARS-CoV-2 is the virus that causes COVID-19.

Beckman Coulter has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the United States, and has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark.

According to the company, the Access SARS-CoV-2 IgG test with 100% sensitivity and 99.6% specificity can also be run on its Access 2 analyzer, a compact table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics.

The test is claimed to be the only SARS-CoV-2 IgG assay which targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. Many vaccine developers are targeting the RBD of the spike protein in their vaccine development.

Beckman Coulter will be seeking EUA for IL-6 and Access SARS-CoV-2 IgM in the near future.



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