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    GeneProof Epstein-Barr Virus (EBV) PCR Kit

    CE IVD
    GeneProof Epstein-Barr Virus (EBV) PCR Kit

    PRODUCT ADVANTAGES

     

    PART OF I/T PANEL

    • Easily combinable with other PCR kits from the Immunocompromised / Transplanted Panel in one workflow
    • Simplifies laboratory workflow

    EASY-TO-USE CONCEPT

    • Single tube ready-to-use Master Mix contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary

    CONTAMINATION PREVENTION

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

    W.H.O. STANDARD BASED QUANTIFICATION

    • Precise and fully traceable quantification according to WHO 1st International Standard NIBSC 09/260

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISEX/025 real-time PCR 25 reactions
    GeneProof Epstein-Barr Virus (EBV) PCR Kit EBV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_Transplatation_QCMD_01_22_EN
    pdf, [200.17 kB]
    open
    GP_EBV_QCMD_10_21_EN_02
    pdf, [218.58 kB]
    open
    GP_EBV_QCMD_10_21_EN_01
    pdf, [218.81 kB]
    open
    GP_EBV_Instand_06_21_EN
    pdf, [1 MB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis

    qualitative and quantitative
    Target Sequence

    DNA sequence of the single copy gene encoding the nuclear antigen 1 (EBNA1) 
    Analytical Specificity

    Epstein-Barr virus, 100 %
    Analytical Sensitivity (LoD)

    reaches up to 196.088 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    reaches up to 289.46 IU/ml with the probability of 95 % (on NIBSC EBV 09/260 using automatic extraction
    croBEE NA16 Nucleic Acid Extraction System)

    		  
    Diagnostic Specificity 100 % (CI95 % : 83.98 % – 100 %) according to EQA panels results
    90.91 % (CI95 % : 79.29 % – 96.60 %) according to Clinical performance analysis 2019
    Diagnostic Sensitivity 100 % (CI95 % : 96.53 % – 100 %) according to EQA panels results
    98.08 % (CI95 % : 88.42 % – 99.90 %) according to Clinical performance analysis 2019
    Linear Range

    1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    1010 – 102.5 IU/ml with precision of ± 0.5 log (using automatic extraction croBEE 201A Nucleic Acid Extraction Kit)
    Dynamic Range 1010 – 196.088 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    1010 – 289.46 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System)
    Reporting Units

    cp/μl
    Conversion Factor

    1 IU = 1 cp
    Metrological Traceability

    EBV NIBSC 09/260 
    Extraction / Inhibition Control

    PCR inhibition and DNA extraction efficiency control (ISEX version)
    Validated Specimen CSF, plasma, whole blood, BAL
    Storage -20 ± 5 °C
    Validated Extraction Method croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Montania 4896 Real-Time PCR termocykler
    StepOne™ / StepOnePlus™ Real-Time PCR System
    Required Detection Channels FAM, HEX
    External Quality Assessment Regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com
    Regulatory Status CE IVD

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    GP_Declaration of Change_EN_CZ
    pdf, [201.13 kB]
    GP_EBV_ Mode d'emploi_FR
    pdf, [232.99 kB]
    GP_EBV_Advisory Notice_EN
    pdf, [924.34 kB]
    GP_EBV_Instruction for Use_EN
    pdf, [243.99 kB]
    GP_EBV_Manual de Uso_ES
    pdf, [248.45 kB]

    Declaration of Conformity

    GP_EBV_Declaration of Conformity_EN
    pdf, [577.27 kB]

    MSDS

    SDS_GeneProof Epstein-Barr Virus (EBV) PCR Kit
    pdf, [276.82 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_EBV_Mic
    micassay, [13.83 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_EBV_Leaflet_EN
    pdf, [150.16 kB]
    GP_IT_Panel_Leaflet_EN
    pdf, [275.02 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 2.0_EN
    pdf, [1.8 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]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    SLAN Real-Time PCR System_EN
    pdf, [1.56 MB]
    StepOne/StepOne Plus Real-Time PCR System_EN
    pdf, [4.42 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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