METADATA
last updated: 2026-03-04 by BA
file_name: 2022-11-01_FDA Website - Antigen EUA Revisions for Serial Repeat Testing.md
file_date: 2022-11-01
title: FDA Website - Antigen EUA Revisions for Serial Repeat Testing
category: regulatory
subcategory: fda-policy
tags: 
source_file_type: website
xfile_type: NA
gfile_url: NA
xfile_github_download_url: NA
pdf_gdrive_url: NA
pdf_github_url: NA
conversion_input_file_type: docx
conversion: manual cut and paste
license: Public Domain
tokens: 394
words: 265
notes: date converted 2024-04-05
web_url: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2#SerialTesting
summary_short: The Antigen EUA Revisions for Serial Repeat Testing summarizes FDA’s November 1, 2022 revision updating authorized uses and labeling for all authorized SARS-CoV-2 antigen tests to emphasize repeat testing after a negative result. It sets new serial-testing instructions—at least twice over three days for symptomatic use and at least three times over five days for asymptomatic use, with 48 hours between tests—and requires EUA holders to submit supplemental requests with updated labeling. The revision also adds one new Condition of Authorization and removes one that FDA determined was no longer needed.


CONTENT

On November 1, 2022, the FDA revised the authorized uses and required updates to product labeling regarding repeat, or serial, testing, for all currently authorized SARS-CoV-2 antigen tests.  The revised Letter of Authorization establishes one additional Condition of Authorization and also eliminates one Condition of Authorization that is no longer needed.

This action is in response to available data about the performance of COVID-19 antigen tests showing that repeat testing after a negative COVID-19 antigen test result increases the chance of an accurate result in people with and without symptoms and could help prevent people from unknowingly spreading the SARS-CoV-2 virus to others. The FDA communicated recommendations consistent with this revision in the August 11, 2022, Safety Communication: [At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative](https://www.fda.gov/medical-devices/safety-communications/home-covid-19-antigen-tests-take-steps-reduce-your-risk-false-negative-results-fda-safety). 

The November 1, 2022 revision requires test developers in the scope of the revision to take certain actions, including submitting a supplemental EUA request to the FDA with updated labeling to reflect the revised authorized uses, as follows:

Where a test was previously authorized for testing of symptomatic individuals (for example, within the first [number specific to each test] days of symptom onset), the test is now authorized for use at least twice over three days with at least 48 hours between tests.
Where a test was previously authorized for testing of asymptomatic individuals (for example, individuals without symptoms or other epidemiological reasons to suspect COVID-19), the test is now authorized for use at least three times over five days with at least 48 hours between tests. 
[Repeat Testing Revision Letter - November 1, 2022](https://www.fda.gov/media/162799/download?attachment)