Abbott wins U.S. emergency use authorization for new Covid-19 antibody test
Abbott wins U.S. emergency use authorization for new COVID-19 antibody test
(Reuters) – Abbott Laboratories said on Monday the U.S. Food and Drug Administration has issued an emergency use authorization for its lab-based COVID-19 antibody blood test.
The test, AdviseDx, can be used to identify a type of antibody called Immunoglobulin M (IgM) in blood samples to determine if someone has been exposure to the novel coronavirus, potentially indicating a recent or prior infection.
Abbott has already received emergency use authorization for seven tests, including molecular tests, a rapid antigen test and another test which can detect a type of antibody called IgG.
The FDA’s emergency use authorization allows the use of unapproved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases with no adequate or approved alternatives.
IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to the coronavirus as these antibodies become undetectable weeks to months following an infection, Abbott said here.
FILE PHOTO: A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker and a medical syringe in this illustration taken April 10, 2020. REUTERS/Dado Ruvic/File Photo
Unlike molecular tests, which can detect whether someone has the coronavirus, antibody tests determine if someone has had a previous infection by detecting disease-fighting proteins called antibodies.
However, antibody tests are not recommended as the sole basis of diagnosis of COVID-19 as these antibodies may not be detected in the early days of the infection.
Shares of Abbott were up 0.5% at $110.21 in early trading.
Reporting by Manojna Maddipatla in Bengaluru; Editing by Amy Caren Daniel
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