GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for detection of the Human Herpesvirus 6 and Human Herpesvirus 7 (HHV-6 and HHV-7) by the real-time Polymerase Chain Reaction (PCR) method.
The HHV-6 detection consists in amplification of the specific DNA sequence of U94 gene coding the putative integrase Rep68 and in measurement of fluorescence increase. The HHV-6 presence is indicated by the FAM fluorophore fluorescence growth. The HHV-7 detection consists in amplification of the specific DNA sequence of U57 gene coding the major capsid protein and in measurement of fluorescence increase. The HHV-7 presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is excluded, controlling also the DNA extraction process quality. IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.
TECHNICAL SPECIFICATION
| Technology | real-time PCR |
| Type of Analysis | qualitative and quantitative |
| Target Sequence | Specific HHV-6A/B DNA sequence of U94 gene coding the putative integrase Rep68 Specific HHV-7 DNA sequence of U57 gene coding major capsid protein |
| Analytical Specificity | Human Herpesvirus 6/7 (HHV-6/7), 100 % |
| Analytical Sensitivity (LoD) | reaches up to 152.05 IU/ml with the probability of 95 % (on NIBSC HHV6B 15/266 using manual extraction GeneProof PathogenFree DNA Isolation Kit) reaches up to 304.91 IU/ml with the probability of 95 % (on (NIBSC HHV6B 15/266 using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Linear Range | 1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit or automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Dynamic Range | 1010 – 152.05 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 304.91 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Reporting Units | IU/µl |
| Metrological Traceability | NIBSC HHV6B 15/266 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control (Internal standard) |
| Validated Specimen | CSF, plasma, whole blood*
*Qualitative PCR DNA test on whole blood is useless for differentiating active from latent HHV-6/7 infection. Almost all healthy individuals have low levels of latent HHV-6 in the whole blood. Therefore, is highly recommended to perform repeated quantification of HHV-6/7 viral loads in the whole blood on consecutive specimens using the same extraction method and quantitative PCR assay for given patient to differentiate active (increasing trend of viral load) from latent (stable or below LoD) HHV-6/7 infection. |
| Storage | -20 ± 5 °C |
| Validated Extraction Method | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Instruments | croBEE Real-Time PCR System* Applied Biosystems 7500 Real-Time PCR System CFX96™/ Dx Real-Time PCR Detection System LightCycler 480 LineGene 9600 Plus Mic qPCR Cycler |
| Required Detection Channels | FAM, HEX, Cy5 |
| External Quality Assessment | regularly tested by QCMD External Quality Assessment panels - for results see www.geneproof.com |
| Regulatory Status | CE IVD for in vitro Diagnostics Use |
* Validated instruments
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit | HHV/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit | HHV/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit | HHV/ISEX/100 | real-time PCR | 100 reactions |