Staphylococcus aureus / mecA gene / S. aureus (PVL) PCR Kit CE/IVD

1 Intended use:
RealCycler SAMAPV is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of mecA gene (methicillin resistant), Panton-Valentine leucocidine toxin (PVL) and Staphylococcus aureus DNA simultaneously in clinical samples.

The staphylococcus aureus pathogen can be quantified when this product is used in combination with the corresponding calibrator (reference RealCycler AURQ.

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 mecA gene is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Panton-Valentine leucocidine toxin (PVL) is detected in the corresponding channel of TxR fluorophore and Staphylococcus aureus is detected in the corresponding channel of Alx647 fluorophore.

3 Technical specifications
Sensitivity
- mecA gene: 100 copies/μL.
- Panton-Valentine leucocidine toxin (PVL): 100 copies/μL.
- Staphylococcus aureus: 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
- mecA gene.
- Panton-Valentine leucocidine toxin (PVL): PVL gene.
- Staphylococcus aureus: NUC gene.

4 Contents
RealCycler SAMAPV includes the AmpliMix and a SAMAPV DNA Positive Control, which contains a mixture of Staphylococcus aureus methicillin resistant and Panton-Valentine leucocidine toxin DNA.
All reagents are ready to use without adding or rebuilding any component.