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NEW YORK – Beckman Coulter announced Tuesday its Access SARS-CoV-2 IgM assay received CE marking and will launch in countries accepting the CE mark. 

The quantitative antibody test showed nearly 100 percent specificity with 1,400 negative samples, as well as 98.3 percent sensitivity 15 to 30 days after symptoms began, the company said in a statement. It binds IgM antibodies on the magnetic particle solid phase and uses a recombinant SARS-CoV-2 protein and enzyme conjugate to detect the antibody. 

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