Bocavirus and Adenovirus PCR Kit CE/IVD

Bocavirus and Adenovirus PCR Kit CE/IVD

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SKU
RealCycler BOAD-
Catalog Number: RealCycler BOAD-

1 Intended use:
RealCycler BOAD is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from respiratory Bocavirus (HBOV) and Adenovirus (ADNV) 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).

The amplification of Bocavirus is detected in the corresponding channel of FAM fluorophore, Adenovirus is detected in the corresponding channel of TxR fluorophore and the internal control is detected in the corresponding channel of Alx532 or HEX fluorophore.

3 Technical specifications
Sensitivity:
- Bocavirus: 10 copies/µL and
- Adenovirus: 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:
Bocavirus (NS1 gene) and Adenovirus (Hexon gene).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).

4 Contents
RealCycler BOAD includes the AmpliMixand a BOAD DNA Positive Control, which contains a mixture of Bocavirus and Adenovirus DNA.
All reagents are ready to use without adding or rebuilding any component.
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