Clostridioides difficile

Combat the rising threat of C. difficile

Clostridioides (formerly Clostridium) difficile infection (CDI) is a leading cause of healthcare-associated infection worldwide.1

It is responsible for 15-25% of healthcare-associated diarrhea2 and can lead to life-threatening complications, such as pseudomembranous colitis and even death.

In Europe, each year C. difficile causes:


Cases of new infection


Estimated associated deaths

€3 billion

in additional healthcare costs

In the United States, each year C. difficile causes:


cases of new infections


Estimated associated deaths

€2.4 million

inpatient hospital days


in additional healthcare costs3

CDI is not limited to the hospital setting

Although CDI is widely regarded as primarily a healthcare-associated infection, it is estimated that up to 1/3 of all cases are community-acquired in the United States.4

CDI cases have been on the rise over the last 20 years; cases of healthcare-associated CDI (HA-CDI) have increased 19.3-fold while cases of community-acquired CDI (CA-CDI) have increased 5.3-fold.5

Speed is critical for early management

C. difficile has proven very difficult to manage and control due to the persistence of its spores in the environment and high transmissibility. In addition to transmission by symptomatic CDI patients, there are patients colonized with C. difficile who are often asymptomatic but can still transmit the infection to others.6

Further complicating efforts to manage CDI, the emergence of strains with increased virulence and resistance to antibiotic therapy in recent years has coincided with a rising incidence of infection and adverse outcomes.7

Researchers and public health specialists now recognize CDI as an emerging threat due to its increasing incidence, severity, and mortality.8

In order to combat the rising threat of C. difficile, accurate and timely diagnosis is essential to prompt earlier, appropriate treatment.

The need for an early, accurate diagnosis to minimize transmission

Rapid and accurate detection of C. difficile remains challenging as
traditional diagnostic methods have inherent limitations:

  • Toxigenic culture: labor-intensive and slow
  • Enzyme immunoassays: limited sensitivity or specificity

Algorithms have been developed using combinations of enzyme immunoassays to overcome shortcomings of individual assays.9 However, these algorithms are complex and may introduce delays in diagnosis.

Molecular diagnostics support appropriate management

Compared to traditional methods for identification of toxigenic C. difficile, nucleic acid amplification tests (NAATs), such as polymerase chain reaction (PCR) assays, offer improved:

  • Speed
  • Sensitivity
  • Specificity


With combined speed and accuracy, PCR testing for C. difficile aids in early, accurate diagnosis of CDI from symptomatic patients reducing the need for complex testing algorithms to initiate appropriate antibiotic treatment and to implement infection control measures that can minimize C. difficile transmission.


  1. Leffler DA, Lamont JT. Clostridium difficile infection. N Engl J Med. 2015 Apr 16;372(16):1539-48. doi: 10.1056/NEJMra1403772. PMID: 25875259.
  2. Marra F, Ng K. Controversies Around Epidemiology, Diagnosis and Treatment of Clostridium difficile Infection. Drugs. 2015 Jul;75(10):1095-118. doi: 10.1007/s40265-015-0422-x. PMID: 26113167.
  3. Garg SK, Lu K, Duncan J, Peterson LR, Liesenfeld O. Equivalent Performance of the Cobas® Cdiff Test for Use on the Cobas® Liat® System and the Cobas® 4800 System. Eur J Microbiol Immunol (Bp). 2017 Dec 5;7(4):310-318. doi: 10.1556/1886.2017.00034. PMID: 29403660; PMCID: PMC5793701.
  4. Collins CE, Ayturk MD, Anderson FA Jr, Santry HP. Predictors and outcomes of readmission for Clostridium difficile in a national sample of medicare beneficiaries. J Gastrointest Surg. 2015;19(1):88-99. doi:10.1007/s11605-014-2638-6
  5. Gupta A, Patel R, Baddour LM, Pardi DS, Khanna S. Extraintestinal Clostridium difficile infections: a single-center experience. Mayo Clin Proc. 2014 Nov;89(11):1525-36. doi: 10.1016/j.mayocp.2014.07.012. Epub 2014 Sep 20. PMID: 25245597.
  6. Nagy E. What do we know about the diagnostics, treatment and epidemiology of Clostridioides (Clostridium) difficile infection in Europe? J Infect Chemother. 2018 Mar;24(3):164-170. doi: 10.1016/j.jiac.2017.12.003. Epub 2017 Dec 27. PMID: 29289484.
  7. Hookman P, Barkin JS. Clostridium difficile associated infection, diarrhea and colitis. World J Gastroenterol. 2009 Apr 7;15(13):1554-80. doi: 10.3748/wjg.15.1554. PMID: 19340897; PMCID: PMC2669939.
  8. Lessa FC, Gould CV, McDonald LC. Current status of Clostridium difficile infection epidemiology. Clin Infect Dis. 2012 Aug;55 Suppl 2(Suppl 2):S65-70. doi: 10.1093/cid/cis319. PMID: 22752867; PMCID: PMC3388017.
  9. Surawicz CM, Brandt LJ, Binion DG, Ananthakrishnan AN, Curry SR, Gilligan PH, McFarland LV, Mellow M, Zuckerbraun BS. Guidelines for diagnosis, treatment, and prevention of Clostridium difficile infections. Am J Gastroenterol. 2013 Apr;108(4):478-98; quiz 499. doi: 10.1038/ajg.2013.4. Epub 2013 Feb 26. PMID: 23439232.