Staphylococcus aureus and Staphylococcus aureus methicillin-resistant (mecA) PCR Kit CE/IVD

Staphylococcus aureus and Staphylococcus aureus methicillin-resistant (mecA) PCR Kit CE/IVD

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SKU
RealCycler SAMA-
Catalog Number: RealCycler SAMA-

1 Intended use:
RealCycler SAMA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Staphylococcus aureus and methicillin-resistant 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
The polymerase chain reaction (PCR) is based on the amplification of a specific region of the DNA/RNA by using complementary primers to the target sequence. Real-time PCR uses marked probes with fluorophores that emit fluorescence in the case of amplification. The cycle of the PCR protocol in which appears significant fluorescence is proportional to the DNA/RNA quantity present in the sample. This value is called Cycle Threshold (Ct) or Cycle Quantification (Cq).
The amplification of mecA gene is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore and Staphylococcus aureus is detected in the corresponding channel of Alx647 fluorophore.

3 Technical specifications
Sensitivity
- mecA gene: 100 copies/μL and
- Staphylococcus aureus: 10 copies/μL.
Specificity
- mecA gene and
- Staphylococcus aureus: NUC gene.

4 Contents
RealCycler SAMA-U / SAMA-G includes the AmpliMix and a MRSA DNA DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
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