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news.Cepheid, an on-demand molecular diagnostics company, has released Xpert Clostridium difficile as a European CE IVD Mark product under the European Directive on in vitro diagnostic medical devices.
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For the first time, European hospitals will have access to a reliable, rapid test for Clostridium difficile, which simultaneously detects and identifies the commonly occurring strains and specifically identifies the more virulent Type 027 strain, the company said.
The new 50-minute test runs on Cepheid’s GeneXpert system, an HAI molecular testing platform, and eliminates the need for multiple tests using less reliable methods, added Cepheid. The GeneXpert system is said to be a closed, self-contained, fully integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination.
David Persing, executive vice president, chief medical and technology officer of Cepheid, said: “The ability to specifically identify the 027 strain will enable tracking of local hospital outbreaks of this strain, which is likely to be of significant value to infection control professionals in curbing the spread of Clostridium difficile.
“Xpert Clostridium difficile comprises the attributes of high accuracy and rapid, on-demand results that are of the greatest importance in controlling transmission of this emerging pathogen.”