Abbott gets emergency authorization for new COVID antibody test

Abbott Labs said Monday its new AdviseDx COVID-19 blood test has been granted emergency use authorization from FDA. The lab-based test can detect the Immunoglobulin M (IgM) antibody, which is useful for determining if a recent infection occurred. IgM antibodies become undetectable weeks to months following infection. Abbott already has an antibody test on the market that can detect IgG antibodies, which last longer in the body after infection. The IgG test is more suitable for determining if a person has recovered from the coronavirus, and for contact tracing and epidemiological studies. Robert Ford, Abbott’s president and CEO, says: “Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery.” In contrast to molecular and antigen tests, antibody tests do not show if a person is currently infected with the coronavirus. Abbott says similar to its IgG antibody test, AdviseDx demonstrated 99.56% specificity and 95% sensitivity.