Research & Development
The FDA approves first POC antibody test for COVID-19 using fingerstick blood samples
24 September 2020 -

Public health agency The US Food and Drug Administration on Wednesday announced an emergency use authorization (EUA) for the first serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples.

In July 2020, the Assure COVID-19 IgG/IgM Rapid Test Device was first authorized for emergency use by certain labs to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, added the agency.

Currently, the Assure COVID-19 IgG/IgM Rapid Test is the only FDA authorized COVID-19 POC serology test and is available by prescription only. The fingerstick blood samples can now be tested in POC settings including doctor's offices, hospitals, urgent care centres and emergency rooms.

The agency stated the Assure test is a lateral flow assay and is authorized for use with venous whole blood, serum, plasma and fingerstick whole blood. This serology POC test, unlike POC COVID-19 diagnostic tests, uses a blood sample from the fingertip to run the test.



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