Epstein-Barr (EBV) / Herpesvirus 6 (HHV6) PCR Kit CE/IVD
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RealCycler EBCMVI-
Catalog Number: RealCycler EBCMVI-
1 Intended use:
RealCycler EBCMVI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Epstein-Barr virus (EBV), Cytomegalovirus (CMV) and Herpesvirus type 6 (HHV6) DNA simultaneously in clinical samples.
BV, CMV and HHV6 pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler EBVQ, CMVQ or HV6Q 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 Epstein-Barr virus is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Cytomegalovirus is detected in the corresponding channel of TxR fluorophore and Herpesvirus type 6 is detected in the corresponding channel of Alx647 fluorophore
3 Technical specifications
Sensitivity:
- Epstein-Barr virus: 10 copies/μL.
- Cytomegalovirus: 10 copies/μL.
- Herpesvirus type 6: 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:
- Epstein-Barr virus: LMP1 gene.
- Cytomegalovirus: Glycoprotein B gene.
- Herpes Virus type 6: U67 gene.
Specificity validation has been performed according to experimental assays and BLAST analysis. (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler EBCMVI includes the AmpliMix dispensed into amplification tubes and an EBCMVI DNA Positive Control, which contains a mixture of Epstein-Barr virus, Cytomegalovirus and Herpesvirus type 6 DNA.
All reagents are ready to use without adding or rebuilding any component.
09/2013: Oral presentation at the Congress of The Insitute of Biomedical Science (IBMS, Birmingham)
"Evaluation of RealCycler Monotest for Viral Detection in CSF samples" Link
RealCycler EBCMVI is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Epstein-Barr virus (EBV), Cytomegalovirus (CMV) and Herpesvirus type 6 (HHV6) DNA simultaneously in clinical samples.
BV, CMV and HHV6 pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler EBVQ, CMVQ or HV6Q 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 Epstein-Barr virus is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Cytomegalovirus is detected in the corresponding channel of TxR fluorophore and Herpesvirus type 6 is detected in the corresponding channel of Alx647 fluorophore
3 Technical specifications
Sensitivity:
- Epstein-Barr virus: 10 copies/μL.
- Cytomegalovirus: 10 copies/μL.
- Herpesvirus type 6: 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:
- Epstein-Barr virus: LMP1 gene.
- Cytomegalovirus: Glycoprotein B gene.
- Herpes Virus type 6: U67 gene.
Specificity validation has been performed according to experimental assays and BLAST analysis. (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler EBCMVI includes the AmpliMix dispensed into amplification tubes and an EBCMVI DNA Positive Control, which contains a mixture of Epstein-Barr virus, Cytomegalovirus and Herpesvirus type 6 DNA.
All reagents are ready to use without adding or rebuilding any component.
09/2013: Oral presentation at the Congress of The Insitute of Biomedical Science (IBMS, Birmingham)
"Evaluation of RealCycler Monotest for Viral Detection in CSF samples" Link
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