COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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FDA Issues EUA for Third Diagnostic SARS-CoV-2 POC Antigen Test

FDA maze of regulations

As antigen-based COVID-19 testing becomes more prevalent, a third test and EUA may mark another breakthrough, adding momentum for wider use of rapid point-of-care coronavirus diagnostic testing.

The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for a third SARS-CoV-2 antigen-based diagnostic test. This EUA was granted on Aug. 18, 2020, and was granted to LumiraDx for their LumiraDx SARS-CoV-2 Ag Test.

This new EUA is similar to the previous two COVID-19 antigen EUAs in that it permits point-of-care (POC) applications of the test and requires that it be used in clinical settings under Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Previously, the FDA had granted EUAs for POC SARS-CoV-2 antigen tests to Quidel and Becton Dickinson. Use of these tests has quickly become prominent, with several federal and state-level funding initiatives and purchase commitments. 

FDA Commissioner Stephen M. Hahn, MD, has promoted antigen COVID-19 tests, saying, “Antigen tests play an important role in the overall response against COVID-19, including as a point-of-care test that can potentially scale up to test millions of Americans quickly.”

Related Resources:

LumiraDx UK Ltd. EUA Letter

Quidel EUA Letter

Becton Dickinson EUA Letter