Enterovirus / Parechovirus PCR Kit CE/IVD
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RealCycler EVPA-
Catalog Number: RealCycler EVPA-
1 Intended use:
RealCycler EVPA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Enterovirus and Parechovirus RNA 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 Enterovirus is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore and Parechovirusis detected in the corresponding channel of TxRfluorophore.
3 Technical specifications
Sensitivity:
- Enterovirus: 1 copy/μL
Parechovirus: 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:
- Enterovirus: 5’UTR region.
- Parechovirus: 5’ UTR region.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
These technical specifications has been verified using QCMD 2011 Enterovirus and QCMD 2011 Parechovirus Panels.
4. Contents
RealCycler EVPA-U / EVPA-G includes the AmpliMix, a retrotranscriptase and an EVPA RNA Positive Control, which contains a mixture of Enterovirus and Parechovirus RNA
All reagents are ready to use without adding or rebuilding any component.
RealCycler EVPA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Enterovirus and Parechovirus RNA 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 Enterovirus is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore and Parechovirusis detected in the corresponding channel of TxRfluorophore.
3 Technical specifications
Sensitivity:
- Enterovirus: 1 copy/μL
Parechovirus: 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:
- Enterovirus: 5’UTR region.
- Parechovirus: 5’ UTR region.
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
These technical specifications has been verified using QCMD 2011 Enterovirus and QCMD 2011 Parechovirus Panels.
4. Contents
RealCycler EVPA-U / EVPA-G includes the AmpliMix, a retrotranscriptase and an EVPA RNA Positive Control, which contains a mixture of Enterovirus and Parechovirus RNA
All reagents are ready to use without adding or rebuilding any component.
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