Pseudomonas aeruginosa, Acinetobacter baumannii, Staphylococcus aureus and Staphylococcus aureus methicillin-resistant (mecA) PCR Kit CE/IVD

1 Intended use:
RealCycler PASM is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Pseudomonas aeruginosa and Acinetobacter baumannii and Staphylococcus aureus and methicillinresistant Staphylococcus aureus 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
In the amplification of Pseudomonas aeruginosa and Acinetobacter baumannii, Pseudomonas aeruginosa is detected in FAM, Acinetobacter baumannii in TxR and the internal control in Alx532. In the amplification of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus, methicillin-resistant Staphylococcus aureus is detected in FAM, Staphylococcus aureus in TxR and the internal control in Alx532.

3 Technical specifications
Sensitivity
- 100 copies/μL, -Pseudomonas aeruginosa,
- 10 copies/μL Acinetobacter baumannii,
- 1000 copies/μL methicillin-resistant Staphylococcus aureus and
- 10 copies/μL Staphylococcus aureus.
Specificity
- Pseudomonas aeruginosa: hcpC gene,
- Acinetobacter baumannii: dnaA gene,
- methicillin-resistant Staphylococcus aureus: mecA gene and
- Staphylococcus aureus: NUC gene.

4 Contents
RealCycler PASM includes the PACI AmpliMix and SAMA AmpliMix, a PACI DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa and Acinetobacter baumannii DNA and an MRSA DNA Positive Control (Staphylococcus aureus methicillin-resistant).
All reagents are ready to use without adding or rebuilding any component.