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

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Releases Updated SARS-CoV-2 Antigen Testing Template

FDA maze of regulations

Antigen testing template updated to recommend including information about asymptomatic testing and multiplexed antigen tests

The US Food and Drug Administration (FDA) announced an update Oct. 26, 2020, to its recommendations for the SARS-CoV-2 antigen testing emergency use authorization (EUA) application template.

The updated recommendations to the antigen test EUA template include additional data and information that should be submitted to support claims for screening asymptomatic patients. With this, the FDA also addresses study data that is recommended when applying for multiplexed antigen tests.

The SARS-CoV-2 antigen test template update and recommendations come at a time when antigen-based COVID-19 testing is becoming more commonly and widely used. Asymptomatic testing has been a recent area of increased attention, and multiplexed tests have gained more interest from many as flu season approaches.

The US government has focused increasing attention and resources on making antigen testing more widely available because of this type of test’s rapid turnaround time and ease of use. “Expanding America’s testing capabilities is the result of partnership and ingenuity between the federal government, private sector and academia,” FDA Commissioner Stephen M. Hahn, MD, said when announcing the issuance a recent antigen EUA. “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.”

The FDA’s updated COVID-19 antigen EUA template can be viewed here. As of Nov. 3, 7 antigen tests have been authorized by the FDA under EUA, compared to 223 molecular tests.

Related Resource: