Finland-based molecular diagnostics firm Mobidiag has received CE mark approval for its qPCR-based test, Amplidiag C. difficile+027.
Suitable for high-volume screening purposes, the qPCR-based test has been carried out using DNA extracted from stool in suspected cases of C. difficile infection (CDI).
Mobidiag CEO Tuomas Tenkanen said: "CDI is a major cause of mortality and increased healthcare costs globally. 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 to meet high-volume screening needs."
The test is said to detect pathogenic C. difficile by discovering tcdB (toxin B) gene and can accurately differentiate hypervirulence-associated 027 ribotype in a single reaction.
The working of Amplidiag C. difficile+027 was assessed with 309 prospective and 35 spiked samples against toxigenic stool culture findings and through independent molecular methods.
Amplidiag C. difficile+027 showed maximum specificity for both tcdB and the 027 ribotype, and sensitivities of 97.8% and 94.4% for tcdB and the 027 ribotype, according to the company.
The 027 ribotype identification was based on two new gene markers, whose combination produces a very high accuracy in identifying 027 ribotype from other ribotypes.