Herpes simplex 1 (HSV1) / Herpes simplex 2 (HSV2) / VZV PCR Kit CE/IVD
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RealCycler HSVTVA-
Catalog Number: RealCycler HSVTVA-
1 Intended use:
RealCycler HSVTVA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Herpes virus type 1 (HSV1), Herpes virus type 2 (HSV2) and Varicella-Zoster Virus (VZV) DNA simultaneously in clinical samples.
HSV1, HSV2 and VZV pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler HV1Q, HV2Q orVZVQ 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 Herpesvirus type 1 is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Herpesvirus type 2 is detected in the corresponding channel of TxRfluorophore and Varicella-Zoster virus is detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity:
- Herpesvirus type 1: 10 copies/μL.
- Herpesvirus type 2: 100 copies/μL.
- Varicella-Zoster Virus: 100 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 polimerase gene.
- Varicella-Zoster Virus: Single-stranted DNA-binding protein gene (ORF 29).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler HSVTVA-U includes the AmpliMix and a HSVTVA DNA Positive Control, which contains a mixture of Herpes virus type 1, Herpes virus type 2 and Varicella-Zoster virus DNA.
All reagents are ready to use without adding or rebuilding any component.
RealCycler HSVTVA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Herpes virus type 1 (HSV1), Herpes virus type 2 (HSV2) and Varicella-Zoster Virus (VZV) DNA simultaneously in clinical samples.
HSV1, HSV2 and VZV pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler HV1Q, HV2Q orVZVQ 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 Herpesvirus type 1 is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 or HEX fluorophore, Herpesvirus type 2 is detected in the corresponding channel of TxRfluorophore and Varicella-Zoster virus is detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity:
- Herpesvirus type 1: 10 copies/μL.
- Herpesvirus type 2: 100 copies/μL.
- Varicella-Zoster Virus: 100 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 polimerase gene.
- Varicella-Zoster Virus: Single-stranted DNA-binding protein gene (ORF 29).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler HSVTVA-U includes the AmpliMix and a HSVTVA DNA Positive Control, which contains a mixture of Herpes virus type 1, Herpes virus type 2 and Varicella-Zoster virus DNA.
All reagents are ready to use without adding or rebuilding any component.
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