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 :
- Tests with Reduced Ability to Detect the SARS-CoV-2 Omicron Variant
- Tests with S-Gene Drop Out – SARS-CoV-2 Detection Should Not Be Impacted
The FDA will update this page as significant new information becomes available.
Update date : 06/12/2021