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

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Antigen SARS-CoV-2 Diagnostic Test EUA Update

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The FDA has issued emergency use authorization for two diagnostic COVID-19 antigen tests as of July 7, 2020. This new category of test is making its way with unique benefits and risks.

The US Food and Drug Administration (FDA) announced its second emergency use authorization (EUA) for antigen testing to now include the BD (Becton Dickinson) SARS-CoV-2 antigen test. 

The EUA announced July 6, 2020, describes this as a point-of-care test marketed as the BD Veritor System for Rapid Detection of SARS-CoV-2. The test can only be operated under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

With the release, FDA Commissioner Stephen M. Hahn, MD, emphasized the role of antigen tests, describing them as a point-of-care test that “can potentially scale up to test millions of Americans quickly.”

Antigen tests have been recognized for their speed in providing results in minutes, at a lower cost, according to the FDA in a May 9 statement. “However,” notes the agency, “antigen tests may not detect all active infections, as they do not work the same way as a PCR test. Antigen tests are very specific for the virus but are not as sensitive as molecular PCR tests.

“This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection. With this in mind, negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions or to prevent the possible spread of the virus due to a false negative,” stated FDA guidance at the time of the first EUA for a COVID-19 antigen test.

The first EUA for a rapid antigen diagnostic test was announced May 9 to Quidel Corporation for its Sofia 2 SARS Antigen FIA.

The FDA provides a list of EUAs that have been granted for SARS-CoV-2 antigen tests. This list will be updated as more EUAs for COVID-19 antigen tests are issued.

Related Resources:

FDA Press Release for BD Antigen Test

FDA Letter of Authorization for BD Veritor System

FDA Press Release for Quidel Corporation Antigen Test

EUA Letter of Authorization for Quidel Corporation Antigen Test

BD Press Release

FDA List of EUAs for SARS-CoV-2 Antigen Tests

COVID-19 TESTING DATA

Helping Your Lab Stay Afloat During Challenging Times

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Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

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