Cytomegalovirus (CMV) DNA and Epstein Bar Virus (EBV) DNA PCR Kit CE/IVD
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RealCycler CMEB-
Catalog Number: RealCycler CMEB-
1 Intended use:
RealCycler CMEB is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) simultaneously in clinical samples.
EBV and CMV pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler EBVQ orCMVQ 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 and Cytomegalovirus is detected in the corresponding channel of TxR fluorophore.
3 Technical specifications
Sensitivity: 10 copies/μL Epstein-Barr Virus and 1 copy/μL Cytomegalovirus.
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 and
- Cytomegalovirus: Glycoprotein B gene.
Specificity validation has been performed according to experimental assays and BLAST analysis. (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler CMEB includes the AmpliMix dispensed into amplification tubes and a CMEB DNA Positive Control, which contains a mixture of Epstein-Barr virus and Cytomegalovirus DNA.
All reagents are ready to use without adding or rebuilding any component.
Publications:
02/2014: Scientific article in the Spanish Society of Clinical Microbiology and Infectious Disease journal (SEIMC)
"Analysis of the results of the SEIMC External Quality Control Program. Year 2012". Link
06/2009: Clinical and Vaccine Immunology. "Evaluation of an Immunofiltration Assay That Detects Immunoglobulin M Antibodies against the ZEBRA Protein for the Diagnosis of Epstein-Barr Virus Infectious Mononucleosis in Immunocompetent Patients" Link
RealCycler CMEB is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) simultaneously in clinical samples.
EBV and CMV pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler EBVQ orCMVQ 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 and Cytomegalovirus is detected in the corresponding channel of TxR fluorophore.
3 Technical specifications
Sensitivity: 10 copies/μL Epstein-Barr Virus and 1 copy/μL Cytomegalovirus.
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 and
- Cytomegalovirus: Glycoprotein B gene.
Specificity validation has been performed according to experimental assays and BLAST analysis. (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler CMEB includes the AmpliMix dispensed into amplification tubes and a CMEB DNA Positive Control, which contains a mixture of Epstein-Barr virus and Cytomegalovirus DNA.
All reagents are ready to use without adding or rebuilding any component.
Publications:
02/2014: Scientific article in the Spanish Society of Clinical Microbiology and Infectious Disease journal (SEIMC)
"Analysis of the results of the SEIMC External Quality Control Program. Year 2012". Link
06/2009: Clinical and Vaccine Immunology. "Evaluation of an Immunofiltration Assay That Detects Immunoglobulin M Antibodies against the ZEBRA Protein for the Diagnosis of Epstein-Barr Virus Infectious Mononucleosis in Immunocompetent Patients" Link
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