Enterovirus + Herpes simplex (HSV1 + HSV2) + Varicella-Zoster virus (VZV) PCR Kit CE/IVD
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RealCycler ENHEVA-
Catalog Number: RealCycler ENHEVA-
1 Intended use:
RealCycler ENHEVA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Enterovirus RNA, Herpes Simplex Virus (type 1 + type 2) and Varicella-Zoster Virus DNA simultaneously in clinical samples.
VZV pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler VZVQ).
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, Herpes Simplex virus (type 1 + type 2) is detected in the corresponding channel of TxR fluorophore and Varicella-Zoster virus is detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity
- Enterovirus: 1 copy/μL.
- Herpes Simplex virus type 1: 10 copies/μL.
- Herpes Simplex virus 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:
- Enterovirus: 5’ UTR region.
- Herpes Simplex virus type 1: US6 gene.
Herpes Simplex virus type 2: DNA polimerase gene.
- Varicella-Zoster virus: Single-stranted DNA-binding protein gene (ORF 29).
4 Contents
RealCycler ENHEVA-U/ENHEVA-U includes the AmpliMix, a retrotranscriptase and an ENHEVA Positive Control, which contains a mixture of Enterovirus RNA and Herpes Simplex virus (type 1 + type 2) and Varicella-Zoster virus DNA.
All reagents are ready to use without adding or rebuilding any component.
Posters and Publications
March 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 ENHEVA is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of Enterovirus RNA, Herpes Simplex Virus (type 1 + type 2) and Varicella-Zoster Virus DNA simultaneously in clinical samples.
VZV pathogen could be quantified if this product is used in combination with the corresponding calibrator (reference RealCycler VZVQ).
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, Herpes Simplex virus (type 1 + type 2) is detected in the corresponding channel of TxR fluorophore and Varicella-Zoster virus is detected in the corresponding channel of Alx647 or Cy5 fluorophore.
3 Technical specifications
Sensitivity
- Enterovirus: 1 copy/μL.
- Herpes Simplex virus type 1: 10 copies/μL.
- Herpes Simplex virus 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:
- Enterovirus: 5’ UTR region.
- Herpes Simplex virus type 1: US6 gene.
Herpes Simplex virus type 2: DNA polimerase gene.
- Varicella-Zoster virus: Single-stranted DNA-binding protein gene (ORF 29).
4 Contents
RealCycler ENHEVA-U/ENHEVA-U includes the AmpliMix, a retrotranscriptase and an ENHEVA Positive Control, which contains a mixture of Enterovirus RNA and Herpes Simplex virus (type 1 + type 2) and Varicella-Zoster virus DNA.
All reagents are ready to use without adding or rebuilding any component.
Posters and Publications
March 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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