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Clostridium difficile is the major cause of healthcare-associated infections (HAIs)

The incidence of C. difficile infection (CDI) is rising globally at an accelerating rate and CDI has become more severe and difficult to treat (1–5). CDI is now clearly more common than HAIs caused by methicillin-resistant Staphylococcus aureus (MRSA) (6–8). Urgent action is needed to improve the management of CDI.

C. difficile infection (CDI)

C. difficile is an anaerobic, Gram-positive, spore-forming bacterium that can be found in the environment and in the gastrointestinal tract of humans and animals. It is the most common cause of antibiotic-associated diarrhoea (2, 9, 10). About 1–15% of healthy adults and the majority of healthy infants are asymptomatic carriers of C. difficile (9, 11, 12). The toxin producing C. difficile causes disease by secreting toxins that damage intestinal mucosa. The disease ranges from mild diarrhoea to serious, life-threatening complications (10, 13, 14). The recurrence rate of the CDI is high as about 20–30% of infected adults may develop a recurrent episode (15-19).  After the first relapse, the recurrence risk is more than 45% (20-22). The clinical and economic impact of recurrent CDI on the healthcare system is significant.

In healthcare settings, patients with CDI and surfaces are the major sources of C. difficile (20, 23-25). Patients and healthcare staff can transmit or acquire C. difficile through the faecal-oral route from contact with surfaces contaminated by C. difficile bacteria or spores (23).  The vegetative form of the C. difficile bacterium generally dies within 6 hours outside the gut (25). However, it is capable of forming spores that are highly resistant to most commonly used cleaning agents and can therefore persist for months in the environment (21, 24, 25).

Clinical and economic burden of CDI

Studies from both Europe and the USA show that there is an increase in CDI incidences.

The recent and largest ever epidemiological study of CDI in Europe, EUCLID (1), showed a 70% increase in the CDI incidence from 2008 to the study period.  Findings of the study also showed a 48-fold variation in country-specific testing rates and 23% of cases were underdiagnosed, translating to about 40.000 missed CDI diagnoses per year in the 482 laboratories that participated in the study. The true number of undiagnosed or misdiagnosed CDI was, however, assumed to be much greater considering that there are about 8.000 hospitals in Europe. Absence of clinical suspicion of CDI and the poor sensitivity of diagnostic testing methods were considered the reasons behind the CDI underdiagnosis.

The European Centre for Disease Prevention and Control (ECDC) estimates the direct cost of healthcare-associated CDI at EUR 3 billion in Europe and it is expected to double over the next four decades (26).

According to the US Centers for Disease Control and Prevention (CDC), there are 250.000 CDIs annually requiring hospitalisation or affecting already hospitalised patients in the USA and about 14.000 deaths linked to CDI (27). About 80.000 hospital-onset CDIs were reported in 2011 (2). The incidence of CDI among hospitalised adults in the USA nearly doubled from 2001 to 2010 (3).

The CDC estimates that CDIs cause an extra healthcare cost of at least $1 billion annually (27).

Diagnostic delays consume healthcare resources

Failure or delay in diagnosing and treating CDI can have serious consequences for the patients. Diagnostic delays may also result in unnecessary infection control measures which are a drain on scarce healthcare resources. Empiric treatment for CDI may often be started before test results become available.  Studies have found that as much as half of empiric therapy for C. difficile is inappropriate (28, 29). Due to concerns for antimicrobial resistance and potential adverse effects, inappropriate use of antimicrobials should be avoided.

Early recognition of CDI, prompt patient treatment and rapid initiation of infection control precautions are the key to successful CDI management.

Make the most of your resources

Orion GenRead® C. difficile is a novel test for identification of toxigenic C. difficile directly from a faecal sample collected from a patient suspected of having CDI. The Orion GenRead solution is based on SIBA® (Strand Invasion Based Amplification), Orion Diagnostica’s proprietary isothermal nucleic acid amplification technology.

The Orion GenRead C. difficile test targets the toxin B gene (tcdB) of C. difficile pathogenicity locus (PaLoc). It is a flexible benchtop solution consisting of a small instrument and the ready-to-use Orion GenRead C. difficile kit. The system enables accurate and affordable nucleic acid based testing for C. difficile with the result available in less than an hour.  Performing the test requires neither special facilities nor expertise in molecular diagnostics. The workflow is simple with only a few hands-on steps and the result is clearly reported as positive or negative. The small-footprint Orion GenRead instrument has an intuitive, multi-lingual user-interface and it is operated through a large touch-screen. The bi-directional connectivity ensures a smooth and safe data flow between the instrument and hospital and laboratory information systems.

The Orion GenRead C. difficile test is a tool for optimal management of patients suspected of having CDI and it promotes efficient use of healthcare resources. Using Orion GenRead C. difficile, the physician can make a rapid and evidence-based clinical decision, the patient will receive appropriate treatment immediately, and consequently, unnecessary use of antibiotics can be avoided. Additionally, severe patient complications and length of hospital stay can be reduced and appropriate infection control interventions can be initiated without delay to prevent the CDI from spreading. All these outcomes translate into healthcare cost savings.

Orion GenRead C. difficile 


Published May, 18 2016


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