Molecular Test Diagnoses Patients with Clostridium difficile Infections

A molecular assay for the rapid diagnosis of patients with Clostridium difficile infection (CDI) offers sensitivity, simplicity, and speed in one test procedure.

The GeneOhm Cdiff assay targets the toxin B gene found in toxigenic C. difficile strains. The CDI test has a rapid turnaround time of less than two hours, facilitating earlier treatment of patients and earlier implementation of infection control interventions to prevent transmission of bacteria to other patients. Until now, rapid diagnosis of CDI has been difficult because traditional methods consist of immunoassays, which lack sufficient sensitivity, and so-called "gold standard” tissue culture cytotoxicity methods, which are difficult to perform and yield results only after several days.

In the United Kingdom, the incidence of C. difficile infections has increased by 40% in the last three years, infecting eight times as many patients as methicillin-resistant Staphylococcus aureus (MRSA) and killing twice as many. In the United States, annually, an estimated 500,000 people are hospitalized and more than 28,000 die from CDI. Rates continue to increase, due to a hypervirulent strain known as BI/NAP1/027. This dangerous strain has now been isolated in at least 38 states, Canada, and 14 European countries.

BD Diagnostics (San Diego, CA; USA), a segment of BD (Becton, Dickinson and Company), announced the CE marking of the BD GeneOhm Cdiff A molecular assay. BD has also submitted the assay to the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) for clearance.

A global medical technology company, BD develops, manufactures, and sells medical devices, instrument systems, and reagents.


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U.S. Food and Drug Administration