Mycoplasma pneumoniae / Chlamydophila pneumoniae / Legionella spp. PCR Kit CE/IVD

1 Intended use:
RealCycler MYCHLE is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Mycoplasma pneumoniae, Chlamydophila pneumoniae and Legionella spp. 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 Mycoplasma pneumoniae is detected in the corresponding channel of FAM fluorophore, Chlamydophila pneumoniae is detected in the corresponding channel of TxR fluorophore, Legionella spp. is detected in the corresponding channel of Alx647 fluorophore and the internal control is detected in the corresponding channel of Alx532 fluorophore or HEX fluorophore.

3 Technical specifications
Sensitivity
- Mycoplasma pneumoniae: 100 copies/µL and
- Chlamydophila pneumoniae: 100 copies/µL and
- Legionella spp.: 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
- Mycoplasma pneumoniae: P1 gene.
- Chlamydophila pneumoniae: DNA-directed RNA polymerase beta chain gene.
- Legionella spp.: 23S-5S ribosomal RNA.
These technical specifications have been verified using QCMD 2012 C. pneumoniae and M. pneumoniae panel and QMCD 2011 Legionella spp. panel.