Clostridium Difficile Rapid Test

【INTENDED USE】 

Clostridium difficile is an anaerobic bacteria acting as an opportunistic pathogen: it  grows in the intestine when the normal flora has been altered by treatment with  antibiotics. Toxinogenic strains of Clostridium difficile cause infections from  milddiarrhea to pseudomembranous colitis, potentially leading to death. Disease is caused by two toxins produced by toxinogenic strains of C.difficile: Toxin A  (tissue-damaging enterotoxin) and Toxin B (cytotoxin). Some strains produce both  toxins A and B, some others produce Toxin B only. The potential role of a third (binary)  toxin in pathogenicity is still debated. The use of Glutamate Dehydrogenase (GDH) as  an antigen marker of C.difficile proliferation has been shown to be very effective  because all strains produce high amount of this enzyme. Clostridium K-SeT allows the  specific detection of C.difficile's GDH in stool specimen. Samples with a positive  Clostridium K-SeT result should be investigated further to test for toxigenicity of the  bacteria. 

【SUMMARY】  

Clostridia (members of the genus Clostridium) are anaerobic, motile bacteria,  ubiquitous in nature, and especially prevalent in soil. Under the microscope, they  appear as long, irregular (often drumstick- or spindle-shaped) cells with a bulge at their  terminal ends. Under Gram staining, C. difficile cells are Gram-positive and show  optimum growth on blood agar at human body temperatures in the absence of oxygen.  When stressed, the bacteria produce spores that are able to tolerate extreme  conditions that the active bacteria cannot tolerate. C. difficile may become established in the human colon; it is present in 2–5% of the  adult population. Sometimes antibiotic therapy for various infections has the adverse  effect of disrupting the normal balance of the gut flora, in which case C. difficile may  opportunistically dominate, causing Clostridium difficile infection.

【DIRECTIONS FOR USE】  

Allow the test device, test sample and buffer to equilibrate to room temperature  (15-30°C) prior to testing. Please refer to procedure card in this kit. Open the  pouch and remove the device. Once opened, run the test immediately. Indicate  the patient’s name or specimen number on the device (one device per sample) 

1. Open the FSS tube and use the screw to collect the stool sample (A). The dilution  ratio must be about 4% w/v. Take care not to take too much (B1) or too little  specimen (B2). For liquid or semi-liquid samples, pipette 80 μL of sample using a  micropipette (not provided) into the FSS vial.

2. Insert the screw into the FSS and tighten the cap. Vortex the preparation to  homogenize (C). The entire stool sample must be suspended into the solution.  

3. Break off the point of the cap (D) and dispense 4 drops of diluted sample into the  sample well of the device as illustrated below. To assure proper delivery, FSS vial  must be held vertically 4. Leave to react for 15 minutes. The results are observed in the reading window.

【Order Information】