Roche receives EUA for Cobas SARS-CoV-2 Duo

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September 2022—Roche announced that the FDA issued emergency use authorization for the Cobas SARS-CoV-2 Duo for use on the fully automated Cobas 6800/8800 systems. The real-time RT-PCR assay is for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of the assay is intended for use as an aid in diagnosing SARS-CoV-2 infection in patients suspected of COVID-19 by their health care provider.