Influenza A + Influenza B / Influenza A H1N1 pdm09, RNA PCR Kit CE/IVD
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RealCycler GRHI-
Catalog Number: RealCycler GRHI-
1 Intended use:
RealCycler GRHI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of RNA from Influenza A, Influenza B and Influenza A H1N1 simultaneously 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).
In the GRIP amplification, Influenza A is detected in the corresponding channel of FAM fluorophore, Influenza B is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
In the HINI amplification, H1N1 is detected in the corresponding channel of FAM fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity:
- 100 copies/µL Influenza A,
- 100 copies/µL Influenza B and
- 500 copies/µL Influenza A H1N1.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- Influenza A (M1 and M2 (matrix protein) gene),
- Influenza B (M1 and M2 (matrix protein) gene) and
- Influenza A H1N1 (hemagglutinin gene).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler GRHI includes the GRIP AmpliMix and HINI AmpliMix, a retrotranscriptase, an Influenza A RNA Positive Control and a FluA H1N1 RNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
RealCycler GRHI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of RNA from Influenza A, Influenza B and Influenza A H1N1 simultaneously 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).
In the GRIP amplification, Influenza A is detected in the corresponding channel of FAM fluorophore, Influenza B is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
In the HINI amplification, H1N1 is detected in the corresponding channel of FAM fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity:
- 100 copies/µL Influenza A,
- 100 copies/µL Influenza B and
- 500 copies/µL Influenza A H1N1.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- Influenza A (M1 and M2 (matrix protein) gene),
- Influenza B (M1 and M2 (matrix protein) gene) and
- Influenza A H1N1 (hemagglutinin gene).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler GRHI includes the GRIP AmpliMix and HINI AmpliMix, a retrotranscriptase, an Influenza A RNA Positive Control and a FluA H1N1 RNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
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