CMV / EBV / HHV6 + HSV1 / HSV2 / VZV PCR Kit CE/IVD
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RealCycler HERPLX-
Catalog Number: RealCycler HERPLX-
1 Intended use:
RealCycler HERPLX is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Herpesvirus type 1 (HSV1), Herpesvirus type 2 (HSV2), Varicella-Zoster virus (VZV), Epstein-Barr virus (EBV), Cytomegalovirus (CMV) and Herpesvirus type 6 (HHV6) DNA in clinical samples.
HSV1, HSV2, VZV, EBV, CMV and HHV6 pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler HV1Q, HV2Q, VZVQ, 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).
In the HSVTVA amplification, Herpes Virus Type1 is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Herpes Virus Type2 is detected in the corresponding channel of TxR fluorophore and Varicella-Zoster virus is detected in the corresponding channel of Alx647 fluorophore.
In the EBCMVI amplification, 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 Herpes Virus type 6 is detected in the corresponding channel of Alx647 fluorophore
3 Technical specifications
Sensitivity:
- Herpesvirus type 1: 10 copies/μL.
- Herpesvirus type 2: 100 copies/μL.
- Varicella-Zoster virus: 100 copies/μL.
- 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:
- Herpesvirus type 1: US6 gene.
- Herpesvirus type 2: DNA polymerase gene.
- Varicella-Zoster virus: Single-stranted DNA-binding protein gene (ORF 29).
- Epstein-Barr virus: LMP1 gene.
- Cytomegalovirus: Glycoprotein B gene.
- Herpesvirus 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 HERPLX includes the HSVTVA AmpliMix and EBCMVI AmpliMix, a HSVTVA DNA Positive Control, which contains a mixture of Herpes virus type 1, Herpes virus type 2 and Varicella-Zoster virus DNA and and EBCMVI DNA Positive Control, which contains a mixture of Epstein-Barr virus, Cytomegalovirus and Herpes virus type 6 DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler HERPLX is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Herpesvirus type 1 (HSV1), Herpesvirus type 2 (HSV2), Varicella-Zoster virus (VZV), Epstein-Barr virus (EBV), Cytomegalovirus (CMV) and Herpesvirus type 6 (HHV6) DNA in clinical samples.
HSV1, HSV2, VZV, EBV, CMV and HHV6 pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler HV1Q, HV2Q, VZVQ, 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).
In the HSVTVA amplification, Herpes Virus Type1 is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore, Herpes Virus Type2 is detected in the corresponding channel of TxR fluorophore and Varicella-Zoster virus is detected in the corresponding channel of Alx647 fluorophore.
In the EBCMVI amplification, 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 Herpes Virus type 6 is detected in the corresponding channel of Alx647 fluorophore
3 Technical specifications
Sensitivity:
- Herpesvirus type 1: 10 copies/μL.
- Herpesvirus type 2: 100 copies/μL.
- Varicella-Zoster virus: 100 copies/μL.
- 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:
- Herpesvirus type 1: US6 gene.
- Herpesvirus type 2: DNA polymerase gene.
- Varicella-Zoster virus: Single-stranted DNA-binding protein gene (ORF 29).
- Epstein-Barr virus: LMP1 gene.
- Cytomegalovirus: Glycoprotein B gene.
- Herpesvirus 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 HERPLX includes the HSVTVA AmpliMix and EBCMVI AmpliMix, a HSVTVA DNA Positive Control, which contains a mixture of Herpes virus type 1, Herpes virus type 2 and Varicella-Zoster virus DNA and and EBCMVI DNA Positive Control, which contains a mixture of Epstein-Barr virus, Cytomegalovirus and Herpes virus type 6 DNA.
All reagents are ready to use without adding or rebuilding any component.
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