Molecular Assay Detects Clostridium difficile Toxin B Gene

A molecular assay rapidly detects the toxin B gene found in toxigenic Clostridium difficile, the bacterial pathogen responsible for C. difficile infection (CDI). It is the first CDI molecular diagnostic that offers sensitivity, simplicity, and speed in one test procedure.

The test, performed directly from stool specimens, targets the toxin B gene found in toxigenic C. difficile strains, including the BI/NAP1/027 epidemic strain associated with a major CDI outbreak in 2003. It can lead to a definitive diagnosis in less than two hours and may facilitate earlier and more appropriate antibiotic treatment of CDI patients. It may also lead to earlier implementation of infection controls.

Becton, Dickinson and Company (BD; Franklin Lakes, NJ, USA) has added this test, which is called the GeneOhm Cdiff assay, to its expanding menu of rapid molecular tests to help prevent healthcare-associated infections, including tests for Staphylococcus aureus and methicillin-resistant S. aureus (MRSA). In addition, BD recently submitted a test to detect the resistant genes associated with vancomycin-resistant Enterococci to Health Canada (Ottawa, ON, Canada) for licensure.

Until now, diagnosing CDI rapidly has proven difficult. Traditional methods, including immunoassays, lack sufficient sensitivity, while tissue culture cytotoxicity methods are difficult to perform and require several days to yield results.

BD announced that Health Canada has licensed the new BD GeneOhm: "Clostridium difficile poses a significant challenge for healthcare facilities across Canada," said Jay Glasscock, Vice President and General Manager, BD in Canada. "We applaud Health Canada for fast-tracking the licensing of this important new test, which will help provide more definitive and more rapid diagnoses of CDI patients. The BD GeneOhm Cdiff assay was developed by BD research scientists in Quebec and will be produced in our new manufacturing facility in Parc Technologique du Quebec Metropolitain."

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Becton, Dickinson and Company
Health Canada