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Cleveland Clinic Gets FDA Emergency Use Authorization for Molecular COVID-19, Flu Combo Test

NEW YORK — The US Food and Drug Administration this week granted Emergency Use Authorization for the Cleveland Clinic's SelfCheck Cobas SARS-CoV-2 + Flu Assay.

The PCR-based test uses Roche's Cobas SARS-CoV-2 & Influenza A/B test, which received EUA from the FDA in late 2020. It is designed for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in anterior nasal swab specimens that are self-collected at home using the SelfCheck Nasal Swabbing Kit.

Use of the test is limited to the Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute, according to the FDA.

In late 2021, the Cleveland Clinic received EUA from the FDA for the SelfCheck Cobas SARS-CoV-2 Assay, which is designed to detect the SARS-CoV-2 genes in anterior nasal swab specimens self-collected using the SelfCheck COVID-19 Swabbing Kit.