Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 | FDA

Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 | FDA

COVID-19 Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19

The U.S. Food and Drug Administration (FDA) re-issued an emergency use authorization (EUA) for the Assure COVID-19 IgG/IgM Rapid Test Device, making it the first authorized serology (antibody) test that can be used at the point of care (POC), meaning it is authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

• The test is authorized for the qualitative detection and differentiation of antibodies against SARS-CoV-2 indicating recent or prior SARS-CoV-2 (COVID-19) infection.
• This EUA authorizes the test for direct use with fingerstick blood samples in patient care settings, like doctors’ offices, hospitals, urgent care centers, and emergency rooms, rather than the samples being sent to a central laboratory for testing.
• Serology test results should not be interpreted to mean that a patient is immune to the virus or as an indication to stop taking steps to protect themselves and others against the spread of COVID-19.

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Questions?

If you have questions about FDA's authorization of this diagnostic test, contact COVID19DX@fda.hhs.gov.