TruQuick™ C.difficile Combo
TruQuick C. diff Combo is a rapid chromatographic immunoassay for the qualitative detection of Clostridium difficile GDH, Toxin A and Toxin B in the feces specimen.
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.1-3 Toxinogenic strains of Clostridium difficile cause infections from mild-diarrhea to pseudomembranous colitis, potentially leading to death.4
Disease is caused by two toxins produced by toxinogenic strains of C. difficile: Toxin A (tissuedamaging 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.4
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.5, 6
TruQuick C. diff Combo allows the detection of GDH, Toxin A and Toxin B specific to C. difficile in fecal specimen.
- 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 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.
- 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. 3. 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.
- 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.
- 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 μL) to each specimen well of the Test Cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
- Read the results at 10 minutes after dispensing the specimen. Do not read results after 20 minutes.
- Balamurugan R, Balaji V, Balakrishnan S. Ramakrishna: Estimation of faecal carriage of Clostridium difficile in patients with ulcerative colitis using real time polymerase chain reaction. Indian J of Med Research. 2008 May;p.472-477.
- Kuijper EJ, Coignard B, Tüll P. Emergence of Clostridium difficile-associated disease in North America and Europe., Rev Clin Micro and Inf. 2006 Oct;12 suppl6, p. 2-18.
- Leyerly DM, Krivan HC, Wilkins DT. Clostridium difficile: its disease and toxins. Clin Micro Rev. 1988 Jan;p. 1-18.
- Ramsey L. et al. Fulminant Clostridium difficile: an underappreciated and increasing cause of death and complications, Ann of Surg. 2002 Mar;235 (3) p. 363-372.
- Wren MW, Kinson R, Sivapalan M, Shemko M, Shetty NR. Detection of Clostridium difficile infection: a suggested laboratory diagnostic algorithm., Br J of Bio Sci. 2009;66(4) p. 175- 179.
- Willis DH, Kraft JA. Confirmation that the latex-reactive protein of Clostridium difficile is a Glutamate Dehydrogenase. J of Clin Micro. 1992 May;30, p. 1363-1364.