Escherichia coli / Streptococcus agalactiae / Listeria monocytogenes PCR Kit CE/IVD

1 Intended use:
RealCycler ECSALI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Escherichia coli, Streptococcus agalactiae and Listeria monocytogenes 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, Listeria monocytogenes is detected in the corresponding channel of Alx647 fluorophore and the internal control is detected in the corresponding channel of Alx532 fluorophore.

3 Technical specifications:
Sensitivity:
- Escherichia coli: 1 copy/μL.
- Streptococcus agalactiae: 1 copy/μL.
- Listeria monocytogenes: 10 copies/μL.

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