By Bill Galluccio
Jan 8, 2021
The agency said that three FDA-approved tests, MesaBiotech Accula, TaqPath Covid-19 Combo Kit, and Linea Covid-19 Assay Kit, may be impacted by the new coronavirus strains but said the impact on testing accuracy is low. If a patient is exhibiting symptoms of COVID-19 and tests negative, the FDA advised them to undergo a different test to confirm the results.
"The FDA will continue to monitor SARS-CoV-2 genetic, viral variants to ensure authorized tests continue to provide accurate results for patients," FDA Commissioner
Stephen M. Hahn, M.D. said in a statement. "While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants."