GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit

GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit

CE IVD

HHV6/7 new product

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

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