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NEW YORK – Beckman Coulter announced Monday its Access SARS-CoV-2 IgG assay received Emergency Use Authorization from the US Food and Drug Administration.

The serology test targets IgG antibodies that recognize the receptor binding domain of the spike protein that SARS-CoV-2 uses to bind to a human cell receptor. These antibodies have the potential to be neutralizing, the company said. The test has confirmed 100 percent sensitivity and nearly 100 percent specificity, the firm added. 

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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.