FDA authorizes COVID-19 antibody test’s emergency use

Oct 13, 2020 - 02:43 PM
FDA product update

The Food and Drug Administration Oct. 12 issued an emergency use authorization for Abbott Laboratories’ AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test.

Abbott said the test, which is used on its ARCHITECT and Alinity platforms, has demonstrated high reliability in its research and external virology laboratory studies, with 99.56% specificity and 95% sensitivity for patients tested 15 days after symptom onset.

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