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# FDA Viral Mutation Impact on Tests Web Page
- URL: https://www.fdaweb.com/fda-viral-mutation-impact-on-tests-web-page/
- Published: 2021-03-30T12:00:00.000Z
- Updated: 2026-09-14T16:52:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149001

FDA has posted a new Web page for clinical laboratory staff and healthcare providers on the impact of viral mutations on Covid-19 molecular, antigen, and serology tests. The agency says it will update the [page](https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-viral-mutations-impact-covid-19-tests?utm%5Fmedium=email&utm%5Fsource=govdelivery) as significant new information become available.

The new Web page includes background on SARS-C0V-2 viral mutations, general information for clinical laboratory staff and healthcare providers, and specific molecular tests affected by viral mutations and recommendations for those tests.

The agency says the Web page builds on a 1/8/21 letter alerting clinical laboratory staff and healthcare providers to the potential for false negative results due to the impact of viral mutations on molecular SARS-CoV-2 tests.