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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 PREVENTION

    • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

     

    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_HHV67_QCMD_06_22_EN_02
    pdf, [223.63 kB]
    open
    ; GP_HHV67_QCMD_06_22_EN_01
    pdf, [222.92 kB]
    open
    ; GP_HHV6_Instand_03_22_EN
    pdf, [1.06 MB]
    open
    ; GP_Transplantation_QCMD_01_22_EN
    pdf, [200.17 kB]
    open
    ; GP_HHV67_QCMD_06_21_EN_02
    pdf, [215.7 kB]
    open
    ; GP_HHV67_QCMD_06_21_EN_01
    pdf, [214.85 kB]
    open
    ; GP_HHV6_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD / EC Directive 98/79/EC
    Intended User For professional use in laboratories with trained staff
    Technologie Real-time PCR
    Type of Analysis Qualitative and quantitative
    Target Sequence

    U94 gene (HHV-6A/B), U57 gene (HHV-7)
    Analytical Specificity Human Herpesvirus 6/7 (HHV-6/7), 100 %
    Analytical Sensitivity
    (LoD with 95% probability)

    Sample Processing

    		 Plasma Whole blood CSF
    GeneProof PathogenFree DNA Isolation Kit 134.9 IU/ml 169.0 IU/ml 152.3 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 312.9 IU/ml 448.4 IU/ml 793.4 IU/ml
    Diagnostic Specificity 97.73 % (CI95%: 92,99 % - 99,41 %)
    Diagnostic Sensitivity 98.72 % (CI95%: 92,09 % - 99,93 %)
    Positive predictive value 96.25 % (CI95%: 88,68 % - 99,03 %)
    Negative predictive value 99.23 % (CI95%: 95,16 % - 99,96 %)
    Linear Range 108 – 102.5 IU/ml with precision of ± 0.5 log
    Dynamic Range

    108 – LoD IU/ml (LoD varying according to the extraction and material used)
    Trueness
    (of expected concentration)    		 0,005 log (CI95%: -0,05 – 0,06) using manual extraction GeneProof PathogenFree DNA Isolation Kit
    -0,002 log (CI95%: -0,08 – 0,07) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit
    Reporting Units IU/ml
    Conversion Factor IU = 0.6 cp / 1 cp = 1.8 IU
    Metrological Traceability NIBSC HHV6B 15/266
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)
    Validated Specimen

    CSF, plasma, whole blood (EDTA)*
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Applied Instruments

    croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System
    AriaMx Real-Time PCR System 
    BioQuant-96 Real-Time PCR System
    CFX96™/ Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR System
    LightCycler 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    QuantStudio TM 5 Real Time PCR System 
    Rotor-Gene Q
    SLAN® Real Time PCR System  
    Detection Channels FAM (HHV-6), HEX/JOE/VIC (IS), Cy5* (HHV-7)
    External Quality Assessment

    Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com

    *NOTE: Due to the availability of international reference standard only for HHV-6, it is possible to monitor HHV-7 in cp/ml reporting units.

     

    Documentation

    Instruction for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    ; GP_HHV_Advisory Notice_EN
    pdf, [408.8 kB]
    ; GP_HHV_Instruction for Use_EN
    pdf, [165.87 kB]
    ; GP_HHV_Instruction_for_Use_ES
    pdf, [232.36 kB]
    ; GP_HHV_Instruction_for_Use_FR
    pdf, [171.82 kB]
    ; GP_HHV_Instruction_for_Use_IT
    pdf, [167.95 kB]

    Declaration of Conformity

    ; GP_HHV_Declaration_of_Conformity_EN
    pdf, [569.71 kB]

    MSDS

    ; GP_HHV67_Safety_Data_Sheet_EN
    pdf, [276.98 kB]

    Publications

    ; GP_IT_Publications_08_2022_EN
    pdf, [276.77 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, [127.85 kB]
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 kB]
    ; GP_Transplantation_QCMD_01_22_EN
    pdf, [200.17 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]
    ; 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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    Customer Support 

    Send request
    +420 730 176 222
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