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The United States Food and Drug Administration (FDA) has granted emergency use authorisation to the Assure COVID-19 IgG/IgM Rapid Test Device.
This device, manufactured in China, allows for point of care (POC) testing of blood from a finger prick to determine whether a person has antibodies to COVID-19. Results are given within 15 minutes.
This is the first antibody test to be approved without the need for a lab, meaning rapid diagnosis of a recent or prior COVID-19 infection can be made at a doctor’s office, emergency department or similar location.
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