Posted by Michael Wonder on 24 Sep 2020
FDA authorises first point of care antibody test for COVID-19
23 September 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first serology (antibody) point of care test for COVID-19.
The Assure COVID-19 IgG/IgM Rapid Test Device was first authorised for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. Today, that emergency use authorisation is being reissued to authorise the test for point of care use using fingerstick blood samples.
This authorisation means that fingerstick blood samples can now be tested in POC settings like doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab for testing.
