FDA grants Emergency Use Authorization for first antibody point-of-care COVID-19 test

pharmafile | September 24, 2020 | News story | Research and Development  

The FDA has issued an Emergency Use Authorization (EUA) for the first antibody (serology) point-of-care test for coronavirus. 

This is in regard to the Assure COVID-19 IgG/IgM Rapid Test Device, which was first authorised for emergency use by certain labs in July 2020 to help identify individuals with antibodies to indicate a prior infection from COVID-19. 

The EUA means that fingerstick blood samples can now be tested in a point-of-care setting like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing. This means the FDA have granted authorisation to almost 50 antibody tests since the start of the pandemic. 

Stephen Hahn, the Commissioner of the FDA, said: “Authorising point-of-care serology tests will enable more timely and convenient results for individuals who want to understand if they have previously been infected with the virus that causes COVID-19. Until today, serology test samples were generally only able to be evaluated in a central lab, which can be time consuming and use additional resources to transport samples and run the test. 

“As more and more point-of-care serology tests are authorised, they will help conserve those resources and may help reduce processing time for other types of COVID-19 tests, as less time is spent on serology tests.”

It is unknown how long antibodies remain after a coronavirus infection, and not enough is known about how much this contributes to immunity to reinfection. Due to this, the FDA cautions people who receive results from an antibody test to keep taking the necessary steps to protect themselves from the virus, including social distancing and wearing masks. The tests also should not be used to diagnose an active infection. 

Conor Kavanagh

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