Epstein-Barr virus (EBV) DNA PCR Kit CE/IVD

Epstein-Barr virus (EBV) DNA PCR Kit CE/IVD

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In stock
SKU
RealCycler EBAR-
Catalog Number: RealCycler EBAR-

1 Intended use:
RealCycler EBAR-UX / EBAR-GX is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Epstein-Barr virus (EBV) DNA in clinical samples.
The system includes an individual vial with the internal control CHIC (Competitive Heterologous Internal Control) out of the AmpliMix, to verify the nucleic acids extraction and 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 Epstein-Barrvirus 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: Epstein-Barr virus: 5 copies/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.

Specificity: Epstein-Barr virus: LMP1 gene.

Specificity validation has been performed according to experimental assays and BLAST analysis. (www.ncbi.nlm.nih.gov/blast).

This technical specifications has been verified using QCMD 2011 EBVDNA11 panel.

4 Contents
RealCycler EBAR-UX / EBAR-GX includes the AmpliMix, a CHIC vial and an EBAR DNA Positive Control, which contains Epstein-Barr virus DNA.
All reagents are ready to use without adding or rebuilding any component.
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