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Mobidiag C. difficile Test Receives CE Mark

NEW YORK (GenomeWeb) — Finland's Mobidiag announced today that its qualitative qPCR-based Clostridium difficile infection (CDI) test has received CE-IVD marking and is now available throughout Europe.

Called Amplidiag C. difficile+27, the test is able to detect CDI in stool samples by identifying the toxin B gene (tcdB), as well as differentiate the hypervirulence-associated 027 ribotype, in a single reaction.

In a study evaluating the test in 309 prospective and 35 spiked samples against toxigenic stool culture findings and independent molecular methods, it showed 100 percent specificity for both tcdB and the 027 ribotype, and sensitivities of 97.8 percent and 94.4 percent, respectively.

"CDI is a major cause of mortality and increased healthcare costs globally," Mobidiag CEO Tuomas Tenkanen said in a statement. "Early identification is important for guiding patient management and infection control measures … [as well as] lowering the overall healthcare costs of CDI."