The FDA has granted 510(k) clearance to the cobas Cdiff Test for detection of Clostridium difficile in stool specimens, the manufacturer announced today. The cobas Cdiff Test (Roche) is the most recent addition to the cobas 4800 System menu, which improves lab efficiency by automating nucleic acid purification, polymerase chain reaction (PCR) set-up and real-time PCR amplification and detection, according to a press release. The Cdiff Test directly targets the toxin B gene in toxigenic strains of C. difficile in symptomatic patients’ stool specimens, helping clinicians make timely decisions and prevent further infections.
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