Clostridium difficile (TcdB y CDT) PCR Kit CE/IVD

1 Intended Use:
RealCycler CDIF is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from B toxin (TcdB) and binary toxin (CDT) of Clostridium difficile simultaneously in clinical samples.
The system includes an internal control CHIC (Competitive Heterologous Internal Control) to prevent false negatives due to reaction inhibition.

2 Principle of the test
The amplification of TcdB is detected in the corresponding channel of FAM fluorophore, CDT is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.

3 Technical specifications
Sensitivity
- TcdB: 100 copies/μL.
- CDT: 100 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.

Specificity
- TcdB: tcdB gene
- CDT: cdtA and cdtB genes.