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Reliable and rapid OneStep detection of toxigenic C. difficile without re-testing

Wednesday, February 11, 2015

The portfolio of CE-IVD certified molecular diagnostic tests of Greiner Bio-One for the detection of nosocomial infections is growing. The Genspeed®C.diffOneStep test identifies toxigenic C. difficile by combining detection of Glutamatdehydrogenase (GDH), Toxin A, Toxin B and binary toxinin 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 death1. In a 2013 published report, the Center for Disease Control (CDC) in the USA categorized C. difficile infections as “Threat Level Urgent”, the highest level available2. 

OneStep ahead – a new way to detect C. difficile

The Genspeed®C.diffOneStep 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.diffOneSteptest provides conclusive results without the need for confirmatory re-testing and enables inter-laboratory comparisons of test results.