Clostridium Difficile Toxin A/B Rapid Test

Product information

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

Advantages of Clostridium difficile Toxin A/B 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.

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 and Toxin B) in stool samples of patients with diarrhea is more significant than culturing the bacteria.

The TOXIN A+B- test is a lateral flow, immunochromatographic rapid test for the qualitative detection of Clostridium difficile Toxin A and Toxin B in human feces. The test device consists of a plastic housing containing two different sticks for the detection of C. difficile Toxin A or C. difficile Toxin B. A colored anti C. difficile Toxin A or C. difficile Toxin B 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 or Toxin B antigen (when present in the sample), forming an antibody antigen complex.

This complex binds to the polyclonal anti-Toxin A or Toxin B antibody in the positive reaction zone, producing a rose-pink colored band. In the absence of Toxin A or Toxin B, 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)

1. Bring all reagents at room temperature.
2. Remove the test device from the pouch by tearing along the split.
3. Open the plastic tube containing the extracted sample.
4. Using the plastic pipette, add 6 drops (200 μL) of the extracted solution into each of the sample wells ( →).
5. Read the test results 15 minutes after addition of the sample to the device.

b)  Samples

1. Remove the test device from the pouch.
2. Add 200 μL of the positive control into the sample well on reaction device.
3. Read the results of the test after 15 minutes.

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.