Abbott receives FDA EUA for COVID-19 antibody test

May 12, 2020

Abbott announced that the U.S. Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) for the company's SARS-CoV-2 IgG lab-based serology blood test, the company said in a press release.

The test, which detects the IgG antibody, runs on the Abbott’s Alinity system.

The company said a study to determine the performance of the SARS-CoV-2 IgG assay found it had greater than 99.6 percent specificity (ability to exclude false positives) and 100 percent sensitivity (ability to exclude false negatives) in patients tested 14 days after symptoms began. Abbott also said it is collaborating with virology labs to validate test results.

Last month, Abbott received FDA EUA and CE Mark for its SARS-CoV-2 IgG antibody blood test on its ARCHITECT system.

Abbott said it plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity platforms, increasing capacity to 60 million tests in June.

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