Clostridium Difficile Test Gets Regulatory Approval

difficile is an anaerobic, toxin producing microorganism known to cause severe diarrhea, pseudomembranous colitis or toxic megacolon, in patients where normal bacterial flora of the gut has been altered following antibiotic therapy.

In a clinical trial program conducted at sites throughout the USA, the Cdiff Test demonstrated excellent performance compared to direct and enrichment toxigenic culture. The test combines high assay sensitivity with rapid turnaround time and a minimum number of pre-analytic steps, to facilitate earlier intervention of patients suffering from C. difficile-associated disease. Earlier intervention can also lead to more effective implementation of infection control measures, which can prevent further transmission to additional patients.

The cobas Cdiff Test (Roche Molecular Systems; Pleasanton, CA, USA) targets the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients. The US Food and Drug Administration (FDA; Silver Springs, MD, USA) has provided 510(k) clearance for the cobas Cdiff Test to detect C. difficile in stool specimens. The test selectively detects a specific C. difficile toxin gene directly from unformed stool samples using real-time polymerase chain reaction (PCR). It can detect the presence of 31 C. difficile toxinotypes and 20 ribotypes and generates robust results automatically, using patented, state-of-the art algorithms.

Paul Brown, PhD, CEO of Roche Molecular Diagnostics, said, “With the addition of the cobas Cdiff Test to the cobas 4800 System menu, Roche is able to expand the tools available to assist clinicians in the management of healthcare associated infections. The cobas Cdiff Test requires less sample handling and provides laboratories with a simplified workflow, when compared to other molecular methods. It also delivers a lower inhibition rate, which means fewer repeat samples and chances for error, enabling better patient care.”

Related Links:
Roche Molecular Systems
US Food and Drug Administration