CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
May 12, 2020—Abbott announced that the FDA issued an EUA for the company’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system. Abbott plans to ship nearly 30 million antibody tests worldwide this month across its Architect and Alinity i platforms and will have capacity for 60 million tests in June.
The company reported that a study to determine the clinical performance of the SARS-CoV-2 IgG assay found it had greater than 99.6 percent specificity and 100 percent sensitivity in patients tested 14 days after symptoms began.
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