for the detection of Clostridium difficile in research samples.
For research use only.

Description:

Clostridium difficile causes antibiotic-associated diarrhea and colitis in animals and humans and is one of the most common nosocomial infections seen in hospitalized patients. An estimated 10-12 million adults are infected with this organism each year in the USA. Enzyme immuno-assays (EIA) are commonly used for diagnosis of C. difficile-associated diarrhea (CDAD). However, these EIA assays for toxin A and toxin B only have approximately 70% - 80% sensitivity (Peterson et al., 2007 Clin Infec Dis 45:1152-60). Accurate identification of pathogenic C. difficile in a timely fashion has great therapeutic, prognostic and economic significance.

The IsoAmp C.diff Detection Kit is a nucleic acid test (NAT) that uses a target amplification method called Helicase-Dependent Amplification (HDA). Two sequence-specific primers amplify a conserved region of toxin A gene as well as an internal control (IC) plasmid with scrambled sequence. The reaction takes only one hour at 65°C and the only equipment required is a waterbath or a heatblock.

Two labeled probes are used in the reaction to simultaneously detect the C. difficile target (FI probe) and IC sequence (DIG probe) and the resulting complexes are detected by the Type II BESt™ cassette (a disposable device designed for rapid, instrument-free and cross-contamination-proof detection of amplicons.) The results are readable on the BESt™ cassette's strip after 5-10 minutes.

A visible T (test) line indicates positive test result, and a visible C (control) line alone indicates negative result (see Figure 1). If no line is shown, the assay is invalid and it can be caused by inhibition. In this case the assay needs to be repeated with additional dilution of the original sample.

Figure 1. Typical Test Results on BESt™ Cassette. (+) Positive for C. difficile (-) Negative for C. difficile

Applications:

The IsoAmp C. diff Detection Kit allows the rapid detection of the toxigenic C. difficile in stool sample in a research setting.

Kit Components :

Storage Conditions: