In a letter to San Juan Capistrano, Calif.-based Quest Diagnostics, the FDA said that, while it has approved tests for influenza A and influenza B, there are no FDA-approved multiplexed tests for flu/SARS-CoV-2 combination testing.
Additionally, no self-collected, at-home FDA-approved tests exist to simultaneously detect and differentiate among the flu types and the virus causing COVID-19, the FDA said.
Quest’s test detects and differentiates nucleic acid from the viruses through nasal swab specimens collected at home by individuals for whom home collection is deemed appropriate by a healthcare provider. The home self-collection is intended for those 18 years of age and older.
“Respiratory viral infections caused by the influenza A and B viruses and SARS-CoV-2 can have similar clinical presentation and diagnostic considerations,” the FDA wrote. “Thus, to differentially detect SARS-CoV-2, information from a test that detects and differentiates the virus that causes COVID-19 and the common influenza viruses that cause seasonal epidemics of flu, influenza A and B (not influenza C), is needed during the flu season that coincides with the COVID-19 pandemic.”