FDA clears Roche’s cobas Cdiff test to detect Clostridium difficile

26 May 2015 (Last Updated May 26th, 2015 18:30)

The US Food and Drug Administration (FDA) has provided 510(k) clearance to Roche to use the cobas Cdiff test to detect Clostridium difficile (C. difficile) in stool specimens.

The US Food and Drug Administration (FDA) has provided 510(k) clearance to Roche to use the cobas Cdiff test to detect Clostridium difficile (C. difficile) in stool specimens.

By targeting the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients, the cobas Cdiff test provides accurate data that helps clinicians in making timely treatment decisions, while aiding in prevention of further infection in healthcare settings.

UNMHSC and Tricore Reference Lab Department of Pathology professor Dr Steve Young said: "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, all on one platform.

"By targeting the toxin B gene found in toxigenic C. difficile strains directly in specimens from symptomatic patients, the cobas Cdiff test provides accurate data that helps clinicians in making timely treatment decisions."

"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."

Roche Molecular Diagnostics head Paul Brown said: "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."

During a clinical trial programme conducted at sites across the US, the test is claimed to have demonstrated superior 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 allow for earlier intervention of patients suffering from C. difficile-associated disease.

According to Roche, earlier intervention can also lead to more effective implementation of infection control measures that can prevent further transmission to additional patients.

The cobas 4800 system provides walk-away automation of nucleic acid purification, polymerase chain reaction (PCR) set-up and real-time PCR amplification and detection to help laboratories achieve maximum efficiency.