FDA provides clearance for Roche MRSA/SA test

The Food and Drug Administration has provided 510(k) clearance for a test that detects methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus.

The cobas MRSA/SA test — created by Switzerland-based pharmaceutical and diagnostics biotech company Roche — uses nasal specimens to detect both organisms, providing accurate and reliable results to prevent and control MRSA/SA infections.

Lance R. Peterson, MD, director of microbiology and infectious diseases research at NorthShore University HealthSystem in Chicago and clinical professor of pathology and medicine at the University of Chicago's Pritzker School of Medicine expressed optimism regarding the newly cleared test.

"The cobas MRSA/SA test demonstrated excellent performance in detecting both MRSA and SA strains in samples collected throughout the U.S.," said Dr. Peterson. "Compared to culture testing, the cobas MRSA/SA test offers confidence in identifying colonized patients the first time they are evaluated, aiding in the prevention of MRSA disease and post-operative SA surgical infections."

The new test also offers less hands-on-time for laboratory staff, streamlining the process, which should reduce costs and decrease turnaround time.



More articles on MRSA:
Preventing HAIs: How the states stack up to the nation
Pulsed xenon UV light kills C. diff and MRSA in hospital rooms, study finds
Healthcare-associated MRSA infections increase mortality risk

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