Seasonal Influenza A H1 + Seasonal Influenza A H3, RNA detection - RNA PCR Kit CE/IVD
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SKU
RealCycler FLUS-
Catalog Number: RealCycler FLUS-
1 Intended use:
RealCycler FLUS is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Seasonal Influenza A H1 and Seasonal Influenza A H3 in clinical samples.
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 Influenza A H1 is detected in the corresponding channel of TxR fluorophore, Influenza A H3 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:
- Seasonal Influenza A H1: 500 copies/µL.
- Seasonal Influenza A H3: 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:
- Seasonal Influenza A H1: hemagglutinin gene.
- Seasonal Influenza A H3: hemagglutinin gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
These technical specifications have been verified using QCMD 2011 Influenza virus Haemagglutinin Typing Panel.
4 Contents
RealCycler FLUS includes the AmpliMix, a retrotranscriptase and a FLUS RNA Positive Control which contains a RNA mixture of Seasonal Influenza A H1 and H3.
All reagents are ready to use without adding or rebuilding any component.
RealCycler FLUS is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Seasonal Influenza A H1 and Seasonal Influenza A H3 in clinical samples.
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 Influenza A H1 is detected in the corresponding channel of TxR fluorophore, Influenza A H3 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:
- Seasonal Influenza A H1: 500 copies/µL.
- Seasonal Influenza A H3: 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:
- Seasonal Influenza A H1: hemagglutinin gene.
- Seasonal Influenza A H3: hemagglutinin gene.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
These technical specifications have been verified using QCMD 2011 Influenza virus Haemagglutinin Typing Panel.
4 Contents
RealCycler FLUS includes the AmpliMix, a retrotranscriptase and a FLUS RNA Positive Control which contains a RNA mixture of Seasonal Influenza A H1 and H3.
All reagents are ready to use without adding or rebuilding any component.
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