JC and BK polyomavirus PCR Kit CE/IVD
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SKU
RealCycler POLI-
Catalog Number: RealCycler POLI-
1 Intended use:
RealCycler POLI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from JCV and BKV polyomavirus simultaneously in clinical samples.
JCV and BKV pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler JCVQ or BKVQ respectively).
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 JCV is detected in the corresponding channels of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore and BKV is detected in the corresponding channel of TxR fluorophore.
3 Technical specifications
Sensitivity:
- JC Polyomavirus: 10 copies/μL.
- BK Polyomavirus: 1 copy/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- JC Polyomavirus: late mRNA
- BK Polyomavirus: large T antigen 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 2010 JC virus and BK virus DNA panel
4. Contents
RealCycler POLI-U / POLI-G includes the POLI AmpliMix and a POLI DNA Positive Control, which contains a mixture of JCV and BKV DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler POLI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from JCV and BKV polyomavirus simultaneously in clinical samples.
JCV and BKV pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler JCVQ or BKVQ respectively).
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 JCV is detected in the corresponding channels of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore and BKV is detected in the corresponding channel of TxR fluorophore.
3 Technical specifications
Sensitivity:
- JC Polyomavirus: 10 copies/μL.
- BK Polyomavirus: 1 copy/μL.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity:
- JC Polyomavirus: late mRNA
- BK Polyomavirus: large T antigen 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 2010 JC virus and BK virus DNA panel
4. Contents
RealCycler POLI-U / POLI-G includes the POLI AmpliMix and a POLI DNA Positive Control, which contains a mixture of JCV and BKV DNA.
All reagents are ready to use without adding or rebuilding any component.
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