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FDA approves stool test for C. difficile
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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.
“Having the ability to provide a result quickly is important when supporting infection control for Clostridium difficile," Steve Young, PhD, from the department of pathology at University of New Mexico Health Sciences Center and Tricore Reference Lab, said in the release. “The cobas 4800 System has the capability to allow for mixed batch testing of the cobas Cdiff Test alongside testing for Methicillin-resistant Staphylococcus aureus, Staphylococcus aureus, and herpes simplex virus 1 and 2 (pending FDA approval), all on one platform. We can run these assays together at least once in each shift rather than once a day, which can greatly improve laboratory efficiency, ultimately leading to better infection control and patient care.”
The approval follows a clinical trial program in which the Cdiff Test “demonstrated excellent performance compared to direct and enrichment toxigenic culture,” with high sensitivity, quick turnaround time and few pre-analytic steps, the release 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 health care associated infections,” Paul Brown, head of Roche Molecular Diagnostics, said in the release. “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.”
Disclosure: Brown is an employee of Roche. Young’s financial disclosures could not be determined at this time.