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7th September 2020  Product update: rapidmicrobiology staff writer

FDA Authorizes Flu & SARS-CoV-2 Multiplex Assay 

The US FDA has granted the Roche cobas® SARS-CoV-2 & Influenza A/B Test Emergency Use Authorization (EUA). The test is already CE-IVD certified.

The test is a multiplex assay authorized to run on the 6800/8800 systems and intended for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A and Influenza B in nasal or nasopharyngeal swab samples. The test is not intended for the detection of Influenza C virus.

With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” said Thomas Schinecker, CEO of Roche Diagnostics.

Roche’s widely-available, fully-automated cobas 6800/8800 Systems, which are used to perform the SARS-CoV-2 & Influenza A/B Test, offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.

The systems provide up to 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift.

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Date Published: 7th September 2020

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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.

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