* For research use only, not for use in diagnostic procedures.
Clostridium Antigen Rapid Test Kit is intended for in vitro detection of Clostridium difficile antigen in stool specimens.
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 Clostridiu 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 highamount of this enzyme.
Clostridium K-SeT allows the specific detection of C. difficile's GDH in stool specimne. Samples with a positive Clostridium K-SeT result should be investigated further to test for toxigenicity for the bacteria.
This is a ready-to-use test that is based on the use of a membrane technology with colloidal gold. A nitrocellulos membrane is sensitized with antibody directed against Clostridium difficile antigen (GDH). THe test's specificity is ensured by an antibody specific to the Clostridium difficile GDH that is conjugated to the colloidal gold. This conjugate is dried on a membrane.
The faecal sample must be diluted into the dilution buffer that is supplied with the test. When 4 drops of the liquid phase of the faecal suspension come into contact with the strip, the solubilised conjugate migrates with the sample by passive diffusion and the conjugate and sample material come into contact with the anti-Clostridium antibody adsorbed onto the nitrocellulose. If the sample contains C. difficile GDH, the conjugate-antigen complex will remain bound to the anti-C. difficile GDH reagent and a red line will develop. Solution continues to migrate to encounter a second reagent that binds the migration control conjugate, thereby producing a red control line that confirms that the test is working properly. The result is visible within 15 minutes.