A new CE-IVD certified molecular test provides rapid, accurate, single-test detection of toxigenic Clostridium difficile without the need for confirmatory retesting.

Greiner Bio-One International GmbH (Frickenhause, Germany, and Kremsmünster, Austria) has now added the Genspeed C.diff OneStep assay to its growing portfolio of CE-IVD certified molecular diagnostic tests for nosocomial infections. Genspeed C.diff OneStep identifies toxigenic C. difficile by combining detection of 4 biomarkers: glutamatdehydrogenase (GDH), Toxin A, Toxin B, binary toxin in a single test. Complete analysis takes under 100 min (depending on PCR-cycler used), including detection on the Genspeed R2 Analyzer.

Genspeed C.diff OneStep’s new “1-test – 4-results” procedure avoids the currently used sequential 2-step procedures that combine different test systems and assay principles for GDH and the C. difficile toxins. It also provides conclusive results without the need for confirmatory re-testing and enables inter-laboratory comparisons of results.

Ready-to-use reagents and automated dispensing minimize the number of manual processing steps within the workflow. The Genspeed R2 Analyzer represents a reliable solution that is virtually service-free system, simple to operate, and available at an attractive cost-benefit ratio.

The new test addresses one of the most serious threats worldwide as C. difficile causes one of the most common serious healthcare system associated infections. In a 2013 report, the USA Center for Disease Control (CDC) categorized C. difficile infections as “Threat Level Urgent,” the highest level available.

All Genspeed products are currently available for sale in the EU and EFTA countries only.

Related Links:
Greiner Bio-One 
Genspeed Analyzer and Assays
Genspeed C.diff OneStep, assay brochure