Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching
    • /
    • search

    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_EBV_Instand_06_20_EN
    pdf, [894.5 kB]
    open
    GP_EBV_Instand_06_21_EN
    pdf, [1 MB]
    open
    GP_EBV_QCMD_2018_EN
    pdf, [283.44 kB]
    open
    GP_EBV_QCMD_2019_EN
    pdf, [241.95 kB]
    open
    GP_EBV_QCMD_C2.2019_EN
    pdf, [232.26 kB]
    open
    Choose all

    Technical specification

    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, [1.49 MB]
    GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    GP_Advisory Notice_CZ_EN
    pdf, [436.02 kB]
    GP_Declaration of Change_EN_CZ
    pdf, [201.13 kB]
    GP_EBV_ Mode d'emploi_FR
    pdf, [232.99 kB]
    GP_EBV_Advisory Notice_EN_CZ
    pdf, [191.37 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, [310.62 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_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, [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 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
    [obfuscate_1_|114|89|99|94|115|63|95|92|103|101|111|106|102|104|102|45|91|102|102]

    Technical Support 

    Send request
    +420 730 176 222
    [obfuscate_1_|114|109|103|105|111|113|108|55|96|101|109|93|103|107|111|110|94|37|92|111|108]

    FAQ

    News

    GeneProof detect OMICRON variant

    A new variant of the SARS-CoV-2 virus, known among others as OMICRON, is spreading around the world.…

    Let's meet at MEDICA 2021 in Düsseldorf

    Meet us at MEDICA 2021 World Forum for Medicine!

    more