Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette

【SUMMARY】
Clostridium difficile is an anaerobic bacteria acting as an opportunistic pathogen: it grows in theintestine when the normal flora has been altered by treatment with antibiotics. 1,2,3 Toxinogenic strains of Clostridium difficile cause infections from mild-diarrhea 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 difficile + Toxin A +Toxin B Combo Rapid Test Cassette allows the detection of GDH, Toxin A and Toxin B specific to C. difficile in fecal specimen.

【DIRECTIONS FOR USE】
Allow the test, specimen, stool collection buffer and/or control to equilibrate to room temperature (15-30°C) prior to testing.
1. To collect fecal specimens:Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean, dry specimen collection container to obtain enough 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 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:
Hold the dropper vertically, aspirate fecal specimens, and then transfer 2 drops of the liquid specimen (approximately 80 µL) into the specimen collection tube containing the extraction buffer. Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Leave the collection tube for reaction for 2 minutes.
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 unscrew the tip of the specimen collection tube. Invert the specimen collection tube and transfer 3 full drops of the extracted specimen (approximately 120 mL) to each specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
5. Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.
6. Note: If the specimen does not migrate (presence of particles), centrifuge the diluted sample contained in the extraction buffer vial. Collect 120µL of supernatant, dispense into the specimen well (S). Start the timer and continue from step 5 onwards in the above instructions for use.