Herpes simplex virus type 1 (HSV1) DNA and Herpes simplex virus type 2 (HSV2) PCR Kit CE/IVD
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RealCycler HSVT-
Catalog Number: RealCycler HSVT-
1 Intended use:
RealCycler HSVT is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Herpesvirus type 1 and 2 simultaneously in clinical samples.
HSV1 and HSV2 pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler HV1Q and HV2Q 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 Herpes virus type 1 is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore and Herpes virus type 2 is detected in the corresponding channel of TxR fluorophore.
3 Technical specifications
Sensitivity: 10 copies/μL Herpes virus type 1 and 10 copies/μL Herpes virus type 2.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity: Herpes virus type 1 (US4 and US5 genes) and Herpes virus type 2 (DNA polymerase gene).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler HSVT includes the AmpliMix and a HSVT DNA Positive Control, which contains a mixture of Herpes virus type 1 and Herpes virus type 2 DNA
All reagents are ready to use without adding or rebuilding any component.
RealCycler HSVT is an in vitro diagnostic kit of reagents which allows real-time PCR qualitative detection of DNA from Herpesvirus type 1 and 2 simultaneously in clinical samples.
HSV1 and HSV2 pathogens could be quantified if this product is used in combination with the corresponding calibrator (references RealCycler HV1Q and HV2Q 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 Herpes virus type 1 is detected in the corresponding channel of FAM fluorophore, CHIC is detected in the corresponding channel of Alx532 fluorophore and Herpes virus type 2 is detected in the corresponding channel of TxR fluorophore.
3 Technical specifications
Sensitivity: 10 copies/μL Herpes virus type 1 and 10 copies/μL Herpes virus type 2.
The analytical sensitivity has been determined by limit dilution. This sensitivity has been showed in repeated assays with reproducibility over 95%.
Specificity: Herpes virus type 1 (US4 and US5 genes) and Herpes virus type 2 (DNA polymerase gene).
Specificity validation has been performed according to experimental assays and BLAST analysis (www.ncbi.nlm.nih.gov/blast).
4 Contents
RealCycler HSVT includes the AmpliMix and a HSVT DNA Positive Control, which contains a mixture of Herpes virus type 1 and Herpes virus type 2 DNA
All reagents are ready to use without adding or rebuilding any component.
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