THE URGENCY TO COMBAT C. DIFFICILE INFECTION
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 infection control measures and adapted therapy.
FACILITATING EARLY DETECTION OF C. DIFFICILE INFECTION
The GenePOC CDiff assay is a 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 detect 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 help to improve patient health, reduce the risk of infection transmission of the infection, and potentially lower mortality and morbidity.
- Easy-to-use: 3 steps in 1 minute.
- Flexible: Adapts to your throughput, allowing up to 8 samples in one run of 70 minutes.
- Precise: Real-time PCR technology.
- Data Management: Displayed on touchscreen, printed, transferred or stored.
- Quality Assurance: Embedded process control to monitor sample processing and ensure optimal quality.
- Waste minimization: Small consumable size resulting in significant reduction of medical waste and associated cost.
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 C. 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 eight samples simultaneously in the same run. If eight samples are not available, the empty places are filled with mock PIEs. 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.
Performance of GenePOC CDiff in comparison with direct culture method
|Direct Culture Method|
LOD: 1250-1500 CFU/mL of sample buffer
* Direct culture method CCFA (Cycloserine Cefoxitin Fructose Agar) plate followed by a Cell Cytotoxicity Neutralization Assay (CCNA) on isolated Clostridium difficile strains from fresh stool specimens.
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.
Can direct swab specimens be used for GenePOC CDiff assay?
Re: Only fresh liquid or soft stool has been validated for this test. Samples from a direct swab need to be evaluated.
If I don’t have eight samples to fulfill the carousel to perform a complete run, what alternatives do I have?
Re: GenePOC MOCK PIEs can be used when less than eight samples are available to perform a run. In case you don’t have any MOCK PIE, assay PIEs filled with Sample Buffer or External Controls can also be used.
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.
GenePOC CDiff assay
Supporting documentation, click here.