Clostridium Difficile Toxin A/B/GDH Rapid Test

Product information

The Clostridium Difficile Toxin A/B/GDH is a lateral flow, immunochromatographic rapid test for the qualitative detection of Clostridium difficile Toxin A, Toxin B and GDH in human
feces.

Advantages of Clostridium difficile Toxin A/B/GDH test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Clostridium difficile is a major cause of antibiotic-associated diarrhea and pseudomembranous colitis. It is now one of the most commonly detected pathogens and an important cause
of nosocomial infections in hospitals and nursing homes. The organism has been isolated from diverse natural habitats, including soils, hay, sand, dung from various large mammals (cows, donkeys and horses), and from dog, cat, rodent and human feces.

C. difficile produces at least three potential virulence factors from which Toxin A and Toxin B are thought to be the most important in the pathogenesis of C. difficile associated diseases. Toxin A is an enterotoxin which seems to interfere with the cytoskeleton of the intestinal epithelial cells, rendering them non functional while Toxin B is a cytotoxin that induces strong cytopathic effects in tissue cultures cell lines.

Known as the common C. difficile antigen, Glutamate Dehydrogenase (GDH) is a metabolic enzyme produced in larges quantities by all toxigenic and non toxigenic strains, making it an excellent marker for organism. Since not all strains of Clostridium difficile produce toxins and approx. 2% of healthy adults as well as up to 50% of children younger than 2 years can be colonized with Clostridium difficile, the detection of the toxins (Toxin A, Toxin B and GDH) in stool samples of patients with diarrhea is more significant than culturing the bacteria.

The Clostridium Difficile A/B/GDH is a lateral flow, immunochromatographic rapid test for the qualitative detection of Clostridium difficile Toxin A, Toxin B and GDH in human feces. The test device consists of a plastic housing containing three different sticks for the detection of C. difficile Toxin A, C. difficile Toxin B or C. difficile GDH.

A colored anti C. difficile Toxin A, C. difficile Toxin B and C. difficile GDH monoclonal antibody colloidal gold conjugate is placed at the left end of the membrane. After collection in a tube containing the extraction solution, the feces sample is dissolved and few drops of this extract are added into each well ( →) of the reaction device. As the test sample flows through the absorbent device, the labelled antibody-dye conjugate binds to the Toxin A, Toxin B or GDH antigen (when present in the sample), forming an antibody antigen complex.

This complex binds to the anti-Toxin A, Toxin B and GDH antibody in the positive reaction zone, producing a rose-pink colored band. In the absence of Toxin A, Toxin B or GDH, there is no line in the positive reaction zone. The reaction mixture continues flowing through the absorbent device, past the positive reaction zone and control zone. Unbound conjugate binds to the reagent in the control zone producing a rose-pink colored band demonstrating that the reagents are functioning correctly.

Test procedure

a) Positive controls (optional)  for CD Tox A and CD Tox B

1. Remove the test device from the pouch
   
2. Add 100 μL of the positive control into the sample well on
   reaction device.

b)  Samples

1. Bring all reagents to come to room temperature before testing.
2. Remove the test device from the pouch.
3. Break the tip of the sample collection device and add 3 drops (100μL) of extracted sample into each sample well on the reaction device.
4. Read the results of the test 15 minutes after addition of the sample on the device.

Interpretation of the results

Negative result: Only one colored band appears in the control zone. No band is visible in the test window.

Positive result: In addition to the control band, a clearly distinguishable band also appears in the test window.

Invalid result: If there is no distinct colored band visible the control zone, the test is inconclusive for the corresponding parameter. In this case, it is recommended that the test be repeated.