New Guidelines for Accurate Diagnosis of C. difficile Infection


Clostridium difficile infection (CDI), a potentially lethal bacterial infection, causes colon inflammation and is responsible for 3,700 deaths in Europe per year.1 This highly symptomatic infection causes fever, diarrhea, abdominal cramping, elevated levels of white blood cells, and blood or mucus in stool.

In spite of these distinct and serious signs, CDI testing is often not performed on patients. In fact, nearly two-thirds of CDI cases are not reported because of the failure of clinicians to request testing for C. difficile toxins in unexplained diarrhea cases, highlighting the necessity to take more actions to prevent the outbreak of this dangerous infection.2

There are a number of systemic reasons behind the underscreening of CDI. First is that screening is carried out based only on the request from a physician in half of all hospitals in Europe.3 Due to these diagnostic strategies, based on physician request, the prevalence of this infection is underestimated.4

According to a recent study, diagnosis was missed in 82 patients with CDI across Europe in a single day, which translates to over 39,000 missed diagnoses per year throughout the continent.5

Secondly, the most accurate testing procedure is not used for CDI in over half of hospitals. More than 20% of samples that tested positive for this infection by study investigators was not diagnosed at the local hospital level. 6

Accurate diagnosis of C. difficile infection

While CDI remains untested and untreated, not only is the health of the patient in danger, but the healthcare system will also incur a significant cost.

The potential cost of this infection is projected to be around €3 billion per annum in Europe and the loss is projected to nearly double over the next four decades.7

The impact of CDI on healthcare systems is serious, as affected patients have to be treated at an additional cost of up to €14,000 for a period of one to three weeks, in comparison with unaffected patients.8

As the occurrence and severity of this infection continues to rise, CDI testing procedures in hospitals need to improve.

Major medical organizations have initiated measures to address the lack of screening for CDI with new guidelines. For instance, the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) has recently made key amendments to their guidelines on CDI diagnosis.9

One of the key updates is a recommendation for empiric diagnosis of all unformed stool samples collected from patients more than three years old. Another recommendation from ESCMID is to use a follow-up Toxin A/B test to assess a positive result obtained from a molecular test for optimal sensitivity and specificity of results.

Fortunately, integrating both test components in a rapid procedure is readily available, enabling healthcare professionals to carry out accurate CDI diagnosis and administer the right treatment immediately.

Other regions in the world, where CDI diagnosis is a challenge, have also started incorporating this testing procedure. For instance, most hospitals in the US diagnose CDI using molecular tests, often as stand-alone diagnoses. Now, they have started adopting the new guidelines outlined by ESCMID.

CDI is responsible for about 30,000 deaths in the US per year – about twice federal estimates and rivaling 32,000 deaths caused by traffic accidents.10 These guidelines should be considered as a roadmap by hospitals in the United States and other nations in order to control the outbreak of CDI and prevent deaths caused by this fatal infection.


Produced from materials originally authored by Gosia Leitch, MBA, MSc, Global Product Director, Alere.


  1. European Centre for Disease Prevention and Control. Clostridium difficile infections. Available at: Accessed on December 5, 2016.
  2. Oake N, et al. The effect of hospital-acquired Clostridium difficile infection on in-hospital mortality. Arch Intern Med. 2010;170:1804-10.
  3. UK Health Protection Agency. English national point prevalence survey on healthcare-associated infections and antimicrobial use, 2011: preliminary data. London; Health Protection Agency, 2012.
  4. Hensgens MP, et al. All-Cause and disease-specific mortality in hospitalized patients with Clostridium difficile infection: a Multicenter Cohort Study. Clin Infect.
  5. Lowy I, et al. Treatment with Monoclonal Antibodies against Clostridiumdifficile Toxins. N Engl J Med. 2010;362;3:197-205.
  6. Bouza E, et al. Results of a phase III trial comparing tolevamer, vancomycinand metronidazole in patients with Clostridium difficile-associated diarrhoea. Clin Micro Infect. 2008;14(Suppl 7):S103-4.
  7. E. J. Kuijper et al. Emergence of Clostridium Difficile-Associated Disease in North America and Europe. Clinical Microbiology and Infection: The Official Publication of the European Society of Clinical Microbiology and Infectious Diseases 12 Suppl 6 (October 2006): 2–18, doi:10.1111/j.1469-0691.2006.01580.
  8. Magalini S, et al. An economic evaluation of Clostridium difficile infection management in an Italian hospital environment. Eur Rev Med Pharmacol Sci. 2012;16:2136–41.
  9. M.J.T. Crobach, T. Planche, C. Eckert, F. Barbut, E.M. Terveer, O.M. Dekkers, M.H. Wilcox, E.J. Kuijper. European Society of Clinical Microbiology and Infectious Diseases (ESCMID): update of the diagnostic guidance document for Clostridium difficile infection (CDI). Clin Microbiol Infect 2016.
  10. Eisier, P. USA Today, “Far more could be done to stop the deadly bacteria C. diff”. August 2012. [Online] Available at: Accessed: 08 Feb 2016.

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Last updated: Mar 21, 2019 at 8:35 AM


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