Escherichia coli and Streptococcus agalactiae PCR Kit CE/IVD

1 Intended use:
RealCycler ECSA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Escherichia coli and Streptococcus agalactiae DNA 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 Escherichia coli is detected in the corresponding channel of FAM fluorophore, Streptococcus agalactiae 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
- Escherichia coli: 1 copy/μL.
- Streptococcus agalactiae: 10 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.

Specificity
Escherichia coli: N-acetylgalactosamine-6-phosphate deacetylase gene.
Streptococcus agalactiae: Sip gene.