CE Marking for Dual-Detection Test for Clostridium difficile

CE-IVD approval has been given for a new multiplex test to detection C. difficile infection (CDI) and simultaneous differentiation of the hypervirulence-associated 027 ribotype.

Mobidiag Ltd. (Espoo, Finland) has launched Amplidiag C. difficile+027, a qualitative qPCR-based test performed from DNA extracted from stool in suspected cases of CDI. The CE-marked test, now available throughout Europe, is both economical and well suited to high-volume screening.

In a single reaction, the test offers highly sensitive and specific detection of pathogenic C. difficile by detecting the tcdB (toxin B) gene, and highly accurate differentiation of the hypervirulence-associated 027 ribotype, which has been linked with more severe disease, hospital outbreaks, increased mortality rates, and recurrent infections. The 027 ribotype identification is based on two novel gene markers, whose combination produces very high accuracy in differentiating 027 from other ribotypes. The novel gene markers were identified based on whole-genome sequencing of 88 C. difficile strains.

Performance was evaluated with 309 prospective and 35 spiked samples against toxigenic stool culture findings (the “gold standard”) and through independent molecular methods. Amplidiag C. difficile+027 demonstrated 100% specificity for both tcdB and 027 ribotype, and sensitivities of 97.8% and 94.4% for tcdB and 027 ribotype, respectively.

“Early identification is important for guiding patient management and infection control measures. It is important not only for patient outcome, but also in lowering the overall healthcare costs of CDI. That is why we are very excited to bring this new product to the market,” said Tuomas Tenkanen, CEO of Mobidiag.

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