Finnish molecular diagnostics company Mobidiag has launched Amplidiag C difficile+027, a qualitative qPCR-based test carried out using DNA extracted from stool in suspected cases of clostridium difficile infection (CDI).
The company also secured CE Mark approval for CDI and hypervirulent 027 ribotype, which will be immediately available throughout Europe.
The test is claimed to accurately 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 the test was evaluated with 309 prospective and 35 spiked samples against toxigenic stool culture findings and through independent molecular methods.
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 company said that Amplidiag C difficile+027 showed maximum specificity for both tcdB and 027 ribotype, and sensitivities of 97.8% and 94.4% for tcdB and 027 ribotype.
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.
The new gene markers were discovered based on whole-genome sequencing of 88 C difficile strains.
The company continues to expand its Amplidiag product line for gastrointestinal infections and the next product in development is intended to detect Helicobacter pylori and related clarithromycin resistance directly from a stool sample in a rapid, single-reaction qPCR test.