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NEW YORK – Beckman Coulter announced Monday that its Access SARS-CoV-2 IgG antibody test is now available in countries accepting the CE mark after receiving CE marking last week.

The serology test detects IgG antibodies that target the receptor-binding domain of the spike protein and has 100 percent sensitivity and nearly 100 percent specificity, the firm said in a statement. A spokesperson for Beckman Coulter, a Danaher business, said the company has submitted the test to the US Food and Drug Administration for Emergency Use Authorization and is expecting the decision soon.

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