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    GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit

    CE IVD
    GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION WITH LESS SAMPLES

    • PCR Kit detects both viruses in a single reaction tube

    QUANTITATIVE DETECTION OF BOTH VIRUSES

    • Precise quantification of the both viruses in two separate detection channels

    HIGH SENSITIVITY AND TRACEABILITY

    • Sensitivity was established with WHO certified strain

    CONTAMINATION ELIMINATION

    • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/025 real-time PCR 25 reactions
    GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_HHV_QCMD_2019_EN
    pdf, [207.48 kB]
    open
    Choose all

    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/ml
    Metrological Traceability

    NIBSC HHV6B 15/266
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    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
    AriaMx Real-Time PCR System 
    CFX96™/ Dx Real-Time PCR Detection System
    LightCycler 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    QuantStudio TM 5 Real Time PCR System 
    Rotor-Gene Q
    SLAN® Real Time PCR System  
    Required Detection Channels

    FAM, HEX, Cy5
    External Quality Assessment regularly tested by QCMD External Quality Assessment panels - for results see www.geneproof.com
    Certification CE IVD

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.49 MB]
    GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    GP_Advisory Notice_CZ_EN
    pdf, [436.02 kB]
    GP_HHV_Instruction for Use_EN
    pdf, [215.11 kB]
    GP_HHV_Manual de Uso_ES
    pdf, [239.17 kB]

    Declaration of Conformity

    GP_HHV_Declaration of Conformity_EN
    pdf, [273.25 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 kB]

    PCR Template

    GP_DNA_3CH_2CH_ABI7500
    edt, [10.72 kB]
    GP_DNA_3CH_2CH_AriaMx
    amxt, [3.61 kB]
    GP_DNA_3CH_2CH_croBEE
    fqt, [4.91 kB]
    GP_DNA_3CH_2CH_QS5
    edt, [8.14 kB]
    GP_DNA_BioRad
    prcl, [1.33 kB]
    GP_HHV 6_7_Mic
    micassay, [27.7 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_HHV_Leaflet_EN
    pdf, [166.04 kB]
    GP_IT_Panel_Leaflet_EN
    pdf, [661.11 kB]

    Manual

    AriaMx Real-Time PCR System_EN
    pdf, [2.31 MB]
    Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
    pdf, [1.43 MB]
    croBEE Real-Time PCR System_EN
    pdf, [5.9 MB]
    LightCycler 480/480 Instrument II_EN
    pdf, [2.18 MB]
    LineGene 9600_9600Plus_K_EN
    pdf, [4.6 MB]
    Mic qPCR Cycler_EN
    pdf, [2.33 MB]
    QuantStudio 3/5 Real-Time PCR System_EN
    pdf, [1.81 MB]
    SLAN Real-Time PCR System_EN
    pdf, [1.56 MB]
    ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
    pdf, [4.2 MB]
    Files are available only for registered users.

    Order

    +420 543 211 679
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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

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