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# Revised Template for Covid Antigen Tests
- URL: https://www.fdaweb.com/revised-template-for-covid-antigen-tests/
- Published: 2020-10-26T12:00:00.000Z
- Updated: 2026-09-14T16:33:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147948

FDA has revised its template that provides current recommendations about data and information that should be submitted to support a pre-Emergency Use Authorization submission for a Covid-19 antigen test. The template is intended to help test developers provide validation data and other information, but it says alternative approaches can be used. It recommends that the following validation studies be conducted for an antigen assay:

- Limit of Detection/Analytical Sensitivity
- Cross-reactivity/Analytical Specificity
- Microbial Interference
- and a Clinical Agreement Study