Neisseria meningitidis (meningococcus) and Streptococcus pneumoniae (pneumococcus) PCR Kit CE/IVD

1 Intended use:
RealCycler MENE is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Neisseria meningitidis and Streptococcus pneumoniae simultaneously in clinical samples.

Streptococcus pneumoniae pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler NEUQ).

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 Neisseria meningitidis is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore andStreptococcus pneumoniae is detected in the corresponding channel of TxR fluorophore.

3 Technical specifications
Sensitivity
- Neisseria meningitidis: 1 copy/μL and
- Streptococcus pneumoniae: 5 copies/μL.
Specificity
- Neisseria meningitidis: ctrA gene and
- Streptococcus pneumoniae: ply gene.

Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).

4 Contents
RealCycler MENE includes the AmpliMix dispensed into amplification tubes and a MENE DNA Positive Control, which contains a mixture of Neisseriameningitidis and Streptococcus pneumoniae DNA.
All reagents are ready to use without adding or rebuilding any component.