Cleveland Clinic Gets FDA Authorization for its COVID-19 and Flu Assay

The Cleveland Clinic has received the FDA’s Emergency Use Authorization for its SelfCheck cobas SARS-CoV-2 + Flu assay.

The real-time polymerase chain-reaction test is authorized for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus and/or influenza B virus RNA in anterior nasal swab specimens. The test is not intended to detect influenza C.

Swab samples can be self-collected at home using the SelfCheck nasal swabbing kit by adults age 18 and up or at an in-person visit with a healthcare provider. Analysis of the test samples is limited to the Cleveland Clinic’s laboratory.