The FDA issued a letter confirming that all emergency use-authorized COVID-19 antibody serology tests should be supplemented with a second, independent test.
The letter, dated Dec. 1, 2020, states that the FDA concurs with the additional statement to Abbott’s (NYSE:ABT) fact sheet for healthcare providers which outlines the risk of false-positve results. FDA received the supplement from Abbott on Oct. 7, 2020. The letter confirms that all serology tests that received FDA emergency use authorization (EUA) should be confirmed with a separate test.
Abbott’s SARS-CoV-2 IgG test, at the time of its approval, was performing with at 99.6% specificity and 100% sensitivity for patients tested 14 days after symptoms began.
Recipients of the Abbott SARS-CoV-2 IgG test should consider confirming positive results by using a second, different antibody assay designed for detecting the same type of antibody.
Abbott received EUA for its SARS-CoV-2 IgG serology blood test for use on its Architect system in April, then won EUA for use of the assay on its Alinity system the following month.
This story has been updated to clarify that