Roche announced that the Food and Drug Administration (FDA) has granted clearance for the cobas MRSA/SA Test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (SA) directly from nasal specimens to prevent and control MRSA/SA infections.
The cobas MRSA/SA Test is an automated, qualitative, in vitro polymerase chain reaction (PCR)-based assay that runs on the cobas 4800 System. It allows 6–94 specimens to be run using real-time PCR amplification and detection. The simple de-cap and sample loading process reduces hands-on time, which offers a more efficient workflow. In clinical tests, the cobas MRSA/SA Test showed excellent performance in detecting both MRSA and SA strains in the collected samples.
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Other cobas system tests include the CT/NG Test (chlamydia/gonorrhea), HPV Test, BRAF V600 Mutation Test, and the EGFR Mutation Test.
For more information call (800 526-6367 or visit Roche.com.