BD launches C.difficile assay
Fully-automated system accurately identifies infected patients
BD Diagnostics has obtained CE Mark approval for its BD MAX Cdiff Assay.
The test is designed to detect 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 infected patients, including those with 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 infection 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 of BD Diagnostics’ diagnostic systems division. “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.
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.