FDA approves new test for intestinal superbug
A new test is available that can rapidly detect Clostridium difficile and the presence of toxin B gene, a strain of bacteria that causes diarrhea, colitis and in some cases, severe intestinal conditions that can result in death.
Cepheid Xpert C. difficile/Epi assay can help clinicians determine if C. difficile is present in a patient's stool, but also if the bacteria is of the epidemic 027/NAP1/BI strain, known for its increased prevalence and hypervirulence.
“Health care professionals in the infectious disease community who have seen various outbreaks of C. difficile-associated infections with aggressive strains in recent years now have a new testing tool to detect this disease,” Alberto Gutierrez, PhD, the director of the Office of In Vitro Diagnostics Device Evaluation and Safety at the FDA's Center for Devices and Radiological Health, said in a press release.
Those at highest risk of developing C. difficile infection include the elderly, patients in hospitals or those that live in a nursing home and people who are taking an antibiotic for another infection.
FDA encourages clinicians to monitor the number of C. difficile infections at their health care facility, particularly if the rate of disease increases or patient outcomes worsen.