Therapy Areas: Devices
US FDA issues Abbott emergency use authorisation for new COVID-19 antibody test
12 October 2020 -

American medical devices and healthcare company Abbott Laboratories (Abbott)(NYSE:ABT) said that the US Food and Drug Administration (FDA) has issued an emergency use authorisation for its lab-based COVID-19 antibody blood test, Reuters news agency reported on Monday.

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 COVID-19, potentially indicating a recent or prior infection.

US FDA's emergency use authorisation 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.

According to Abbott, IgG is longer lasting in the body after an infection, but IgM is more useful for determining a recent exposure to COVID-19, as these antibodies become undetectable weeks to months following an infection.

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, Reuters added.



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