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Clostridium Difficile Rapid Test
A rapid test for the qualitative detection of Clostridium difficile bacteria in feces. For professional in vitro diagnostic use only.
- Description
- Specifications
-
【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】
Cat. No.
Product
Specimen
Format
Pack ICGD-C61
Clostridium Difficile Rapid Test Cassette
Feces
Cassette
25T
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