Mycoplasma pneumoniae and Chlamydophila pneumoniaea PCR Kit CE/IVD

1 Intended use:
RealCycler MYCH is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Mycoplasma pneumoniae and Chlamydophila pneumoniae 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 and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.

3 Technical specifications
Sensitivity
- 1 copy/μL Mycoplasma pneumoniae and
- 10 copies/μL Chlamydophila pneumoniae.
Specificity
- Mycoplasma pneumoniae: P1 gene and
- Chlamydophila pneumoniae: DNA-directed RNA polymerase beta chain gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
A cross reaction has been discarded with Adenovirus, Bocavirus, Legionella pneumophila, Mycobacterium tuberculosis, Streptococcus pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii, Coxiella burnetii and Staphylococcus aureus.

QCMD Panel: - QCMD 2012 C. pneumoniae and M. pneumoniae.

Posters and Publications
May 2013: Poster at the XVII Congress of Spanish Society of Clinical Microbiology and Infectious Disease (Zaragoza)
"Spectrum of respiratory viruses in children with lower respiratory tract infection"Link