FDA has created a page on its website devoted to providing information about the impact of SARS-CoV-2 viral mutations on covid-19 tests, recommendations for clinical laboratory staff and healthcare 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’s analysis to date has identified the following EUA-authorized molecular tests whose performance could be impacted by SARS-CoV-2 viral mutations:
- Accula SARS-CoV-2 Test (Mesa Biotech Inc.)
- Linea COVID-19 Assay Kit (Applied DNA Sciences, Inc.)
- TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2 DoD, Xpert Omni SARS-CoV-2 (Cepheid)
For more information, visit FDA.