Adenovirus PCR Kit CE/IVD
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SKU
RealCycler ADNV-
Catalog Number: RealCycler ADNV-
1 Intended use:
RealCycler ADNV is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Adenovirus in clinical samples.
Adenovirus pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler ADVQ).
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 Adenovirus is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity: 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:
Adenovirus: Hexon gene.
RealCycler ADNV specificity corresponds with the 57 serotypes of Adenovirus.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
This technical specification has been verified using QCMD 2011.
4 Contents
RealCycler ADNV includes the AmpliMix dispensed into amplification tubes and an ADNV DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
RealCycler ADNV is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Adenovirus in clinical samples.
Adenovirus pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler ADVQ).
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 Adenovirus is detected in the corresponding channel of FAM fluorophore and CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore.
3 Technical specifications
Sensitivity: 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:
Adenovirus: Hexon gene.
RealCycler ADNV specificity corresponds with the 57 serotypes of Adenovirus.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
This technical specification has been verified using QCMD 2011.
4 Contents
RealCycler ADNV includes the AmpliMix dispensed into amplification tubes and an ADNV DNA Positive Control.
All reagents are ready to use without adding or rebuilding any component.
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