As of April 7 there was only one antibody test that had received an Emergency Use Authorization (EUA) from the
FDA: a test by Cellex (headquarters in Research Triangle Park). According to the
EUA it takes fifteen to twenty minutes to get the test results but the test must be performed in an authorized lab. This test, according to
testing done in China, has a specificity rate of 95.6% and a sensitivity rate of 93.8%. A
highly sensitive test rarely overlooks an actual positive. A highly specific test rarely registers a positive classification for anything that is not the target of testing.
However Dr. Marc Siegel said on the
Tucker Carlson show, concerning the Cellex test, that “we are not entirely there yet.” He said that he had contacted Adm. Brett Giroir, the assistant secretary for health at the U.S. Department of Health and Human Services (HHS), who told him the current approved tests, made by Cellex Inc., have a one in three rate of not getting it right. But he apparently then went on to say that he prefers the test by Abbott Labs on their ID NOW platform which does not require a central lab and allows doctors to swab a nose and get a result in five to fifteen minutes. But that’s comparing apples and oranges, since Abbott tests for the presence of the virus and Cellex tests for antibodies. So it’s unclear to me exactly what he was talking about. Why would the FDA approve a test with a one in three chance of not getting it right?