GenoType CDiff permits the detection and differentiation of non-pathogenic, virulent and hypervirulent (including ribotype 027) strains of C.difficile directly from stool & rectal swabs, or from culture.

Clostridium difficile (C.difficile) is a gram positive, anaerobic, spore forming intestinal bacteria found in approximately 3% of adults and 66% of infants. Infections rarely occur in these patient groups as normal intestinal bacterial flora help to maintain a healthy balance. Generally problems occur if patients are being treated with antibiotics for other infections. This therapy can cause disruption of the normal bacterial population allowing C.difficile to grow in unusually large numbers.

C.difficile infections vary in severity from mild diarrhoea to sometimes life threatening inflammation of the intestines. The term Clostridium Difficile Associated Diarrhoea (CDAD) is used to refer to symptomatic patients with C.difficile infections.

Since its discovery back in the late 1970s, C.difficile has emerged as a major cause of Hospital Acquired Infection. The bacteria can be spread via contact between patients, staff and visitors or via environmental surfaces. Spores produced by the bacteria can survive on surfaces for a long time and are difficult to eradicate.

Clinically relevant strains of C.difficile produce Toxins A & B and in some cases a binary toxin. In recent years, the emergence of more virulent strains, that have increased toxin production, has added burden and demand on health services. This increase in toxin production results in higher pathogenicity, elevated risk of transmission and makes eradication more difficult. CDAD patients stay up to 3 weeks longer in hospital and require more complex and expensive management. This in turn results in major financial costs. In Europe it is estimated that €3bn is spent per year on CDAD patients.

It is important to be able to differentiate patients who have non-pathogenic strains of C.difficile from those with virulent or hyper-virulent strains as early as possible. With this information, clinicians and infection control practitioners are able to take measures to treat appropriately, implement isolation procedures, identify outbreaks and also spot emerging strains.

Current laboratory methods for testing C.difficile are either time consuming (cytotoxicity or toxigenic culture), offer poor sensitivity (EIA) or are expensive (PCR). Additional to this, all of these methods offer limited information about different strains without further work needing to be performed.

The Hain Lifescience GenoType CDiff offers hospitals a same day, simple to use, proven platform that can differentiate between non-pathogenic, virulent and hypervirulent (including ribotype 027) strains. As well as having in built controls the assay also has markers for: