MONDAY, JUNE 18, 2018

Cobas MRSA/SA Test gets FDA approval

FDA OKs new test to detect MRSA, SA infections.
FDA OKs new test to detect MRSA, SA infections. |

The Food and Drug Administration recently issued 510(k) clearance for Roche’s cobas MRSA/SA Test, Roche said Monday.

The test detects methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) in their early stages.

The cobas MRSA/SA test operates through the automated cobas 4800 System. The lab staff de-caps and loads a sample vial into the system and lets the test -- a polymerase chain reaction (PCR)-based assay -- run its course. The test provides results from a single nasal specimen.

This new method should help researchers further prevent and contain MRSA/SA infections.

The test saves resources, as it requires little hands-on-time, so lab staff are free to perform other tasks, increasing productivity. The test also shortens turnaround time, which should reduce lab costs.

"Health-care-associated infections continue to be a leading cause of mortality in U.S. medical settings,” Paul Brown, head of Roche Molecular Diagnostics, said. “With the addition of the cobas MRSA/SA Test to our expanding menu of tests for the cobas 4800 System, Roche offers laboratories and clinicians a highly efficient molecular solution to aid in the overall management and prevention of health-care-associated infections, leading to lower costs for hospitals and optimal patient care."