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Beckman Coulter's SARS-CoV-2 IgG Antibody Test Obtains FDA Emergency Use Authorization

Beckman Coulter said that its Access SARS-CoV-2 IgG assay has received Emergency Use Authorization or EUA from the U.S. Food & Drug Administration.

The company noted that it has already shipped tests to more than 400 hospitals, clinics and diagnostics laboratories in the U.S.

The company said it is able to deliver more than 30 million tests per month. It has begun distribution of the new antibody test globally to countries that accept the FDA EUA and CE Mark.

The Access SARS-CoV-2 IgG Assay is a qualitative immunoassay that detects IgG antibodies directed to the receptor binding domain of the spike protein of the novel coronavirus that is driving the ongoing global pandemic. It is believed that these antibodies have the potential to be neutralizing antibodies and may play a role in lasting immunity.

The test has a confirmed 100% Positive Percent Agreement (sensitivity) and 99.6% Negative Percent Agreement (specificity) and at 18 days post PCR confirmed positive test.

The company said it will seek EUA for IL-6 and Access SARS-CoV-2 IgM in the near future.

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