Abbott wins U.S. emergency use authorization for new COVID-19 antibody test
(Reuters) - Abbott Laboratories announced Monday that the U.S. Food and Drug Administration has granted emergency approval for its laboratory-based COVID-19 antibody blood test.
The AdviseDx test can be used to identify a type of antibody called immunoglobulin M (IgM) in blood samples to determine if someone has been exposed to the new coronavirus, which may indicate a recent or previous infection.
Abbott has already received emergency approval for seven tests, including molecular tests, a rapid antigen test, and another test that can detect a type of antibody called IgG.
FDA emergency approval allows unapproved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening illnesses without adequate or approved alternatives.
IgG lasts longer in the body after infection, but IgM is more useful for determining recent exposure to the coronavirus because these antibodies are undetectable weeks to months after infection, Abbott said. Http://newsfile.refinitiv.com / getnewsfile / v1 / story? guid = urn: newsml: reuters.com: 20201012: nPn8KFxtXa.
Unlike molecular tests that can tell if someone has the coronavirus, antibody tests determine if someone has previously had an infection by detecting disease-fighting proteins called antibodies.
Antibody testing is not recommended as the sole basis for diagnosing COVID-19, however, as these antibodies may not be detected in the early days of infection.
Abbott's shares rose 0.5% in early trading to $ 110.21.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel)
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