Pseudomonas aeruginosa / Enterobacteriaceae / Staphylococcus aureus PCR Kit CE/IVD
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RealCycler PAENSA-
Catalog Number: RealCycler PAENSA-
1 Intended use:
RealCycler PACISA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Pseudomonas aeruginosa, Enterobacteriaceae 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 of amplification CHIC (Competetive 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 Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, the internal control CHIC is detected in the corresponding channel of Alx532, the amplification of Enterobacteriaceae is detected in the corresponding channel of TxR fluorophore, Staphylococcus aureus is detected in the corresponding channel of Alx647 fluorophore and the internal control is detected in the corresponding channel of Alx532 fluorophore.
3 Technical specifications
Sensitivity
- Pseudomonas aeruginosa: 1 copies/μL.
- Enterobacteriaceae: 10 copies/μL.
- Staphylococcus aureus: 1 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity
- Pseudomonas aeruginosa: hcpC, ecfX and gyrB genes.
- Enterobacteriaceae: rpoB gene.
- Staphylococcus aureus: NUC gene.
4 Contents
RealCycler PAENSA includes the AmpliMix dispensed into amplification tubes and a PAENSA DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa, Enterobacteriaceae and Staphylococcusaureus DNA.
All reagents are ready to use without adding or rebuilding any component
RealCycler PACISA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Pseudomonas aeruginosa, Enterobacteriaceae 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 of amplification CHIC (Competetive 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 Pseudomonas aeruginosa is detected in the corresponding channel of FAM fluorophore, the internal control CHIC is detected in the corresponding channel of Alx532, the amplification of Enterobacteriaceae is detected in the corresponding channel of TxR fluorophore, Staphylococcus aureus is detected in the corresponding channel of Alx647 fluorophore and the internal control is detected in the corresponding channel of Alx532 fluorophore.
3 Technical specifications
Sensitivity
- Pseudomonas aeruginosa: 1 copies/μL.
- Enterobacteriaceae: 10 copies/μL.
- Staphylococcus aureus: 1 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity
- Pseudomonas aeruginosa: hcpC, ecfX and gyrB genes.
- Enterobacteriaceae: rpoB gene.
- Staphylococcus aureus: NUC gene.
4 Contents
RealCycler PAENSA includes the AmpliMix dispensed into amplification tubes and a PAENSA DNA Positive Control, which contains a mixture of Pseudomonas aeruginosa, Enterobacteriaceae and Staphylococcusaureus DNA.
All reagents are ready to use without adding or rebuilding any component
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