SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests – Announcement from USFDA

The SARS-CoV-2 virus has mutated over time, resulting in genetic variation in the population of circulating viral strains over the course of the COVID-19 pandemic. Molecular, antigen, and serology tests are affected by viral mutations differently due to the inherent design differences of each test.

This announcement provides information regarding the impact of viral mutations on COVID-19 tests, recommendations for clinical laboratory staff and health care providers, and information about certain tests for which the FDA has identified potential impacts on performance due to SARS-CoV-2 genetic mutations.

The FDA will list tests on this page as the FDA’s analyses identify tests for which performance may be impacted for known SARS-CoV-2 variants.

Information Update in USFDA Portal covers the following :

Genetic Variations: Background and Considerations

General Information for Clinical Laboratory Staff and Health Care Providers

Omicron Variant: Molecular Tests That May Be Impacted

Other Variants: Molecular Tests that May Be Impacted


The FDA will update this page as significant new information becomes available.

Source :

Update date : 06/12/2021

Leave a Reply