TS1029
TSRapid Clostridium Difficile GDH/ Toxin A+B Combo Rapid Test – Feces
The TS RAPID™ Clostridium difficile GDH / Toxin A+B Combo Rapid Test is a rapid immunochromatographic assay developed for the qualitative detection of Clostridium difficile glutamate dehydrogenase (GDH) antigen and toxins A and B in human fecal samples. GDH is an enzyme produced by both toxigenic and non-toxigenic strains of C. difficile, making it a highly sensitive marker for initial screening. Toxins A and B are responsible for the pathogenic effects of the bacterium and are critical for confirming active infection. By detecting both GDH and toxins simultaneously, this combo test offers a comprehensive approach to C. difficile diagnosis, improving both sensitivity and specificity.
| Detection | Fast Result | High Sensitivity |
|---|---|---|
| Antigen detection | Reliable results in 10-20 minutes | Clinically validated performance values |
| No Lab Equipment Required | Easy Implementation | CE Certified |
| Clinical for rapid diagnosis and suitable for field work | With feces sample fast and practical test possibility | European standards manufactured accordingly |
| Storage Temperature | 2-30°C / 35.6-86°F | Sensitivity | 98.7% (95% CI: 93.1%-100%) |
| Sample Type | Feces | Specificity | 98.3% (95% CI: 94.2%-99.8%) |
| Time to Result | 10-20 min. | Accuracy | 98.5% (95% CI: 95.7%-99.7%) |
| Shelf Life | 24 months | Overall Accuracy | 96.0% (95% CI: 93.1%-97.9%) |
Result Interpretation Guide
A positive result is indicated when two distinct colored lines appear—one in the control line region (C) and another in the test line region (T). The intensity of the test line may vary depending on the concentration of Clostridium difficile antigens present in the specimen. A negative result appears when only one colored line is seen in the control region (C), and no line appears in the test region (T).
If the control line fails to appear, the result is invalid. This could be due to insufficient specimen volume or procedural errors. In such cases, review the instructions and repeat the test with a new cassette Therefore, any visible line in the test region should be considered positive.