BD Diagnostics, a segment of BD (Becton, Dickinson and Company), has announced that it obtained CE Marking of the BD MAX™ Cdiff Assay. The assay detects the toxin B gene (tcdB), which has been shown to be present in all toxigenic C. difficile and is essential for disease.
Run on the fully automated BD MAX™ System, the assay is designed to rapidly and accurately identify patients with Clostridium difficile infection (CDI), including those caused by hypervirulent strains. Rapidly and accurately identifying these patients enables appropriate treatment and infection control measures to be implemented quickly, which 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 diarrhoea and colitis that can progress to toxic megacolon, sepsis and death. More than 95% of antibiotic-associated pseudomembranous colitis cases are caused by CDIs, resulting in more than $1 billion in healthcare costs annually.