Reliable and Rapid Detection of Toxigenic C. difficile without Re-testing 

The portfolio of CE-IVD certified molecular diagnostic tests of Greiner Bio-One for the detection of nosocomial infections is growing. The Genspeed® C.diff OneStep test identifies toxigenic C. difficile by combining detection of Glutamatdehydrogenase (GDH), Toxin A, Toxin B and binary toxin in a single, molecular diagnostic test. The complete analysis including the detection on the Genspeed® R2 Analyzer takes under 100 min.

The new test addresses one of the most serious threats to health care systems worldwide, the infection with Clostridium difficile infections (CDI), which is believed to be the most common healthcare-associated infection. The disease is causing antibiotic-associated diarrhoea (AAD) that may lead to pseudomembranous colitis and even to death. In a 2013 published report, the Center for Disease Control (CDC) in the USA categorised C. difficile infections as ‘Threat Level Urgent’, the highest level available.

The Genspeed® C.diff OneStep test features a simple, one-step molecular diagnostic test following the motto ‘OneStep - one test - four results’. The test is avoiding the currently used sequential 2-step diagnostic test procedures, which combine different test systems and assay principles for GDH and the C. difficile toxins. The rapid Genspeed® C.diff OneStep test provides conclusive results without the need for confirmatory re-testing and enables inter-laboratory comparisons of test results.

Ready-to-use reagents and automated dispensing minimise the number of manual process steps within the workflow. The Genspeed® R2 Analyzer represents a reliable solution for customers interested in fast and accurate results. The virtually service-free system is simple to operate and is available at an attractive cost-benefit ratio.