Clostridium difficile is the leading cause of infectious diarrhea in hospitals and long-term care facilities in industrialized countries. As well as causing mild to severe diarrhea, this bacterium can also initiate potentially fatal intestinal disorders such as inflammation of the large intestine, toxic megacolon and sepsis. Rapid, sensitive and specific diagnosis of the presence of C. difficile is therefore essential for the implementation of effective control measures.
Facilitating early detection of C. difficile infection
The GenePOC CDiff assay is a simple, rapid and qualitative in vitro diagnostic test to detect the toxin B gene of C. difficile in liquid or soft stool specimens. Performing this test enables healthcare professionals to ascertain the presence of C. difficile within 70 minutes after obtaining a stool specimen from a patient. Early detection can lead to better control and management of C. difficile infection, which in turn can improve patient health, reduce the risk of transmission of the infection, and potentially lower mortality and morbidity.
GenePOC CDiff assay: Results available within 70 minutes
The GenePOC CDiff assay can provide results from up to eight samples from unformed (liquid or soft) stool specimens in approximately 70 minutes. This innovative test enables healthcare professionals to quickly and efficiently ascertain the presence of C. difficile quickly and efficiently.
The future is Point of Care Testing
A lengthy diagnostic process increases the risk of transmission and or severity of an infection, and endangers patients’ lives. Point of Care testing (POCT) significantly reduces the turnaround time to obtain a diagnostic result. The GenePOC CDiff assay fully conforms to the WHO ASSURED requirements of POC (Affordable, Sensitive, Specific, User-Friendly, Rapid & Robust, Equipment-free, Deliverable to end-users). It can be performed by medical professionals such as nursing staff at the hospital bedside of a patient, in an operating room, or in the patient’s home – at any time of the day or night as well as in the laboratory.
- Easy, 3-step process:
- Extract sample and discharge it into sample buffer tube.
- Transfer the sample buffer into the single-use disposable microfluidic cartridge (PIE).
- Load the PIE into the revogene™ instrument and press start.
- Fast: Results are available within 70 minutes.
- Precise: Accurate assay performance facilitates real-time diagnosis, reporting and treatment.
- Transparent: The results displayed on the touchscreen user interface can be printed, transferred or stored via the USB port.
- Quality Assurance: Each PIE contains a Process Control that monitors the sample processing effectiveness to ensure high quality.
- Low Total Cost of Ownership: An affordable initial cost is supplemented by low operational costs, reduced laboratory waste and rationalization of labor resources.
- Waste minimization – The small PIE design leads to significant reduction of hazardous waste disposable in health-care establishments.
Fully automated sample preparation and testing
The GenePOC CDiff assay is a simple, rapid and qualitative in vitro diagnostic test that utilizes automated sample preparation and real-time polymerase chain reaction (PCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile in liquid or soft stool specimens. The test is intended for use as an aid to diagnosis of C. difficile infection (CDI) in humans in conjunction with clinical and epidemiological risk factors. The test is performed using the revogene, which fully automates and integrates sample homogenization, dilution, lysis, amplification, and fluorogenic detection of the amplified PCR products.
Up to eight samples simultaneously
The revogene can be used to process from one up to a maximum of eight samples simultaneously in the same run. If eight samples are not available, the empty places are filled with MOCK PIEs, which simulate the presence of a diagnostic test PIE to maintain thermodynamic balance within the run. On completion of a run, the results are computed by the system from measured fluorescent signals and embedded calculation algorithms. Results are displayed on the touchscreen user interface and may then be printed, transferred using a connectivity option, and/or stored using the USB port.
Comparison of GenePOC CDiff against the C.diff culture method
The Limit of Detection (LoD) of the GenePOC CDiff assay was determined using fecal matrix negative for toxigenic C.difficile spiked with different concentrations of C.difficile bacterial suspension. Two strains of C.difficile (ATCC BAA-1805 and ATCC 43255) were tested in replicate of 24 per concentration by two operators using two different lots of GenePOC CDiff kits. The LoD95% is defined as the lowest concentration at which 95% of all replicates tested positive. The LoD of the GenePOC CDiff assay ranged from 200 to 250 CFU/mL of sample buffer.
1 Kyne et al. 2002. Health care costs and mortality associated with nosocomial diarrhea due to Clostridium difficile. Clin. Infect. Dis. 34(3):346-353.
2 Loo et al. 2005. A predominantly clonal multi-institutional outbreak of Clostridium difficile-associated diarrhea with high morbidity and mortality. N. Engl. J. Med. 353(23):2442-2449. (Erratum, N. Engl. J. Med. 354(20):2200, 2006.)
3 McDonald et al. 2005. An epidemic, toxin gene-variant strain of Clostridium difficile. N. Engl. J. Med. 353(23):2433-2441.
4 O’Brien et al. 2007. The emerging infectious challenge of Clostridium difficile-associated disease in Massachusetts’s hospitals: clinical and economic consequences. Infect. Control Hosp. Epidemiol. 28(11):1219-1227.
5 Rousseau et al. 2012. Clostridium difficile carriage in healthy infants in the community: a potential reservoir for pathogenic strains. Clin. Infect. Dis. 55(9):1209-1215.
6 Collignon et al. 1993. Heterogeneity of Clostridium difficile isolates from infants. Eur J Pediatr. 152(4):319-322.
7 Eyre et al. 2014. Diverse sources of C. difficile infection. N. Engl. J. Med. 370(2):183-184.
8 Bartlett. 2006. Narrative review: the new epidemic of Clostridium difficile-associated enteric disease. Ann. Intern. Med. 145(10):758-764.
9 Drudy et al. 2007. Emergence and control of fluoroquinolone-resistant, toxin A-negative, toxin B-positive Clostridium difficile. Infect. Control Hosp. Epidemiol. 28(8):932-940
10 Cohen et al. 2010. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect. Control Hosp. Epidemiol. 31(5):431-455.
11 Bartlett JG. 2002. Clinical practice. Antibiotic-associated diarrhea. N. Engl. J. Med. 346(5):334-339.
12 Public Health Service, Centers for Disease Control and Prevention, National Institutes of Health. Biosafety in microbiological and biomedical laboratories-5th Edition. HHS Publication No. (CDC) 21-1112. Revised December 2009
13 Clinical and Laboratory Standards Institute. Protection of laboratory workers from occupationally acquired infections; Approved Guideline-Fourth Edition.
GenePOC CDiff assay
Supporting documentation, click here.
Disclaimer: CE-IVD available. Not offered for sale in the U.S. and Canada.
Can direct swab specimens be used for CDiff?
Re: Only fresh stool liquid or soft stool has been validated for this test. Samples from a direct swab need to be evaluated.
What transport media is compatible with the CDiff?
Re: Only fresh liquid stool has been validated. The use of transport media must be evaluated.
How long I can keep the sample in the PIE prior to performing the run?
Re: Once the PIE is unsealed, it must be used within 30 minutes.
If I don’t have eight samples to fulfill the carousel to perform a complete run, what alternatives do I have?
Re: MOCK PIEs or assay PIEs filled with Sample Buffer or External Controls can be used when less than eight samples are available to perform a run.
What is the shelf life of the CDiff kit?
Re: The GenePOC CDiff assay has a six-months shelf life from the production date. Products are shipped with a minimum shelf life of three months. Please refer to the kit and/or individual pouch label for details on the expiration date.
What is the ideal temperature to store GenePOC CDiff kits?
Re: GenePOC CDiff kits can be stored at 2-25°C.
How do I place an order?
Re: Please refer to the “Contact” section of our website (http://www.genepoc-diagnostics.com/contact/) for a list of distributors in your area.