Clostridium difficile is a bacterial pathogen of major importance to European public health. The pathogen causes deaths in hospitals and is spread easily. Humans can be asymptomatic carriers and pre-screening of patients prior to hospital admittance would be desirable enabling containment and informed decisions regarding antibiotic therapy before illness results.

Currently, C. difficile is detected by a combination of clinical observation, bacterial culture and/or immunological analysis of toxins. This approach carries a number of inherent flaws:

  • Diagnosis is performed only after the patient has already developed symptoms,
  • The methods are relatively slow where the speed of detection is of the essence,
  • The methods used to detect toxins mean that the patient is already exhibiting symptoms, or is about to,
  • Existing immunological methods are relatively insensitive.

What is also needed is a method for detecting the spore form of C. difficile. If this could be achieved then it would be possible to detect the pathogen in patients before surgery enabling a more informed choice of antibiotic therapy and containment. Moreover, the ability to detect the spore would allow detection of spores that contaminate the hospital (this being a major problem for the NHS as well as being a financial burden with regard to hospital hygiene). Lastly, the ability to detect the spore would enable environmental detection of C. difficile in farmed animals for example.

SporeGen® has developed monoclonal antibodies that detect only spores of C. difficile and we are currently using these antibodies to develop diagnostic kits for rapid identification of C. difficile. SporeGen® is also developing a more sophisticated method for spore detection referred to as an affinity biosensor, a device that in its final form would be hand held, portable and for use for environmental detection.