Clostridium Difficile Antigen Rapid Test Cassette

• Easy to use
• No equipment required
• High sensitivity and specificity
• Fast results at 10 minutes

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, Clostridium difficile(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. Clostridium difficile infection is associated with broad-spectrum antibiotic therapy and is the most common cause of infectious diarrhea in hospital patients. Pathogenic strains of C. difficile produce two protein exotoxins, toxin A and toxin B, which cause colonic mucosal injury and inflammation. C.difficile may become established in the human colon; 1,2,3it is present in 2–5% of the adult population.

Allow the test, specimen, buffer to reach room temperature (15-30°C) prior to testing.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8°C if not tested within 6 hours. For long term storage, specimens should be kept below -20°C.
2. To process fecal specimens:
For Solid Specimens:
Unscrew the cap of the specimen collection tube, then randomly stab the specimen collection applicator into the fecal specimen in at least 3 different sites to collect approximately 50 mg of feces (equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
For Liquid Specimens:
Unscrew the cap of the specimen collection tube, hold the dropper vertically, aspirate liquid fecal specimens, and then transfer 2 drops (approximately 80 µL) into the specimen collection tube with extraction buffer. Tighten the cap onto the specimen collection tube, and then shake the specimen collection tube to mix the specimen and the extraction buffer. Leave the tube alone for 2minnutes.

3. Bring the pouch to room temperature before opening it. Remove the test cassette from the foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
4.Hold the specimen collection tube upright and open the cap onto the specimen collection tube. Invert the specimen collection tube and transfer 2 full drops of the extracted specimen (approximately 80μL) to the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. Read results at 10minutes. Do not read results after 20 minutes

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