New Assay Released for Rapid Identification of Clostridium difficile Infection

BD Diagnostics has announced CE Marking of the BD MAX^TM Cdiff Assay. The assay detects the toxin B gene (tcdB), which has been shown to be present in all toxigenic C. difficile infections and is essential for Cdiff virulence.

The BD MAX^TM Cdiff Assay is designed to run on the fully automated BD MAX^TM System, for the rapid and accurate detection of patients with Clostridium difficile infection (CDI). Rapidly identifying these patients enables appropriate treatment and infection control measures to be implemented quickly, and may improve patient outcomes.

“As CDI rates continue to increase in healthcare facilities worldwide, rapid molecular testing for detection of toxigenic C. difficile can help expedite appropriate treatment, reduce length of stay, and improve patient outcomes,” said Tom Polen, President, BD Diagnostics – Diagnostic Systems. “The BD MAX Cdiff Assay launch is another important milestone in our effort to deliver a range of clinical tests on the BD MAX System, offering laboratories improved efficiency, turnaround time, and productivity.”

According to a recent study in the American Journal of Infection Control, nucleic acid amplification tests provide better sensitivity over enzyme immunoassay and glutamate dehydrogenase testing algorithms for detection of toxigenic C. difficile. C. difficile is a gram-positive bacterium that is responsible for the development of antibiotic-associated diarrhea and colitis that can progress to toxic megacolon, sepsis and death. More than 95 percent of antibiotic-associated pseudomembranous colitis cases are caused by CDIs, resulting in more than $1 billion in healthcare costs annually.

The BD MAX™ Cdiff Assay represents the third CE-Marked assay on the BD MAX™, the first fully automated bench-top molecular system designed to perform a broad range of molecular testing. The BD MAX™ System was developed to offer laboratories a simplified platform with true walk-away automation and the versatility to perform a broad range of molecular tests.