NORTH CHICAGO (dpa-AFX) - Abbott (ABT) announced the FDA has issued Emergency Use Authorization for the company's AdviseDx SARS-CoV-2 IgM (Immunoglobulin M) lab-based serology test for use on the ARCHITECT and Alinity platforms. The company said its data showed 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset.
Abbott earlier developed an IgG blood test, which often is the antibody that is longer-lasting in the body after infection. The IgM antibody is useful for determining a recent infection as these antibodies become undetectable weeks to months following infection.
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