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    GeneProof Epstein-Barr Virus (EBV) PCR Kit

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

    PRODUCT ADVANTAGES

     

    W.H.O. STANDARD BASED QUANTIFICATION

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

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one 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

     

    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
    Regulatory Status CE IVD / EC Directive 98/79/EC
    Intended User For professional use in laboratories with trained staff
    Test Principle Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection
    Type of analysis

    Qualitative and quantitative
    Target Sequence

    Gen EBNA1
    Analytical Specificity

    Epstein-Barr virus, 100 %
    Analytical Sensitivity
    (LoD with 95% probability)

    Sample Processing

    		 Plasma Whole blood CSF BAL   
    GeneProof PathogenFree DNA Isolation Kit 196.1 IU/ml 129.2 IU/ml 110.8 IU/ml 206.0 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 289.5 IU/ml 250.2 IU/ml 586.1 IU/ml 138.1 IU/ml
    Diagnostic Specificity 94.19 % (CI95%: 86.35 % - 97.84 %)
    Diagnostic Sensitivity 99.10 % (CI95%: 96.45 % - 99.84 %)
    Positive Predictive Value 97.79 % (CI95%: 94,63 % - 99.18 %)
    Negative Predictive Value 94.59 % (CI95%: 90.76 % - 99.58 %)
    Linear Range

    Extraction method

    		 Precision Plasma Whole blood BAL Precision CSF  
    GeneProof PathogenFree DNA Isolation Kit ± 0,5 log 1010 – 102.5 IU/ml 1010 – 102.5 IU/ml 1010 – 102.5 IU/ml ± 0,6 log 1010 – 102.5 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 1010 – 103 IU/ml 1010 – 103 IU/ml 1010 – 103 IU/ml
    Dynamic Range 1010 – LoD IU/ml (LoD varying according to the extraction method and material used)
    Trueness

    -0.07 log (CI95%: -0.13 – 0.00) using manual extraction GeneProof PathogenFree DNA Isolation Kit

    -0.08 log (CI95%: -0.13 – 0.03) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit
    Precision – repeatability • Intra-assay SD of log concentration = 0.084 (CI95%: 0.068 – 0.110)
    Precision – reproducibility

    • Inter-assay SD of log concentration = 0.092 (CI95%: 0.059 – 0.202)

    • Inter-lot SD of log concentration = 0.112 (CI95%: 0.072 – 0.246)

    • Total SD of log concentration = 0.115 (CI95%: 0.074 – 0.254)
    Reporting Units

    cp/ml
    Conversion Factor

    1 IU = 1 cp
    Metrological Traceability

    1st WHO International Standard for Epstein-Barr Virus for Nucleic Acid Amplification Techniques, code: EBV NIBSC 09/260
    Extraction / Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)
    Validated Specimen CSF, plasma, whole blood (EDTA), BAL
    Storage Conditions -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 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    Montania 4896 Real-Time PCR termocykler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    StepOneTM / StepOne PlusTM Real-Time PCR System
    Detection Channels FAM (EBV), HEX/JOE/VIC (IS)
    External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels -results at www.geneproof.com

    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_EBV_ Mode d'emploi_FR
    pdf, [232.99 kB]
    ; GP_EBV_Instruction for Use_EN
    pdf, [368.75 kB]
    ; GP_EBV_Instructions_for_Use_ES
    pdf, [357 kB]
    ; GP_EBV_Instructions_for_Use_FR
    pdf, [357.1 kB]
    ; GP_EBV_Instruction_for_Use_IT
    pdf, [173.75 kB]

    Declaration of Conformity

    ; GP_EBV_Declaration_of_Conformity_EN
    pdf, [617.55 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, [176.19 kB]
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 kB]
    ; GP_Transplatation_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 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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    Customer Support 

    Send request
    +420 730 176 222
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