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    GeneProof Hepatitis B Virus (HBV) PCR Kit

    CE 1023 IVD
    GeneProof Hepatitis B Virus (HBV) PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SPECIFICITY 

    • Secured by targeting the DNA conservative sequence of ORFx
    • Prevents analysis failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
    • Detection of all HBV genotypes A – H

    PRECISE QUANTITATIVE DETECTION

    • Precise and fully traceable quantification according to WHO International HBV DNA Standard NIBSC 10/266
    • Excellent results in EQA panel testing (QCMD, INSTAND)

    CONTAMINATION ELIMINATION

    • Single tube Ready to use Master Mix contains Uracil DNA N-glycosylase (UNG) and dUTPs eliminating possible contamination with amplification product

    HIGH SENSITIVITY

    • Sensitivity was established with certified strain (HBV NIBSC 10/266)
    • Ensures excellent sensitivity reaches up to 13.9 IU/ml

    SINGLE TUBE READY-TO-USE MASTER MIX

    • Contains all components for PCR amplification
    • No additional pipetting of PCR reagents necessary
    • Reduces the need for qualified laboratory staff
    • Ensures reproducibility of results

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/025 real-time PCR 25 reactions
    GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_HBV_QCMD_08_21_EN
    pdf, [189.09 kB]
    open
    GP_HBV_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    GP_HBV_QCMD_2020
    pdf, [195.24 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE1023 IVD 
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis

    qualitative and quantitative
    Target Sequence

    DNA conservative sequence of open reading frame X (ORFx)
    Analytical Specificity

    HBV genotype A-H, precore mutants HBV (HBeAg negative), 100 %

    Analytical Sensitivity 

    (LoD with the probability of 95 %)

    		 36.9792 IU/ml (on HBV NIBSC 05/148 using GeneProof PathogenFree DNA Isolation Kit),
    64.067 IU/ml (on HBV NIBSC 10/266 using croBEE 201A Nucleic Acid Extraction Kit),
    croBEE NA16 Nucleic Acid Extraction System)
    13.9 IU/ml (on HBV NIBSC 10/266 using manual extraction SpinStar Viral Nucleic Acid Kit 1.0
    with SpinStar Pretreatment Solution)
    Diagnostic Specificity

    100% (CI95% : 99.06% – 100%)
    Diagnostic Sensitivity  100% (CI95% : 95.90% – 100%)
    Linear Range

    1010 – 102 IU/ml with precision of ± 0.5 log
    Dynamic Range

    1010 – 36.9792 IU/ml (using GeneProof PathogenFree DNA Isolation Kit)
    1010 – 64.067 IU/ml (using croBEE 201A Nucleic Acid Extraction Kit)
    Reporting Units

    IU/µl
    Metrological Traceability

    HBV NIBSC 10/266 (4th WHO International Standard)
    Validated Specimen plasma, serum
    Storage -20 ± 5 °C
    Validated Extraction Method croBEE NA16 Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Validated 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
    DT lite Real-Time PCR System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudioTM 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOneTM/StepOne PlusTM 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

     

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_HBV_Advisory Notice_EN
    pdf, [466.14 kB]
    GP_HBV_Advisory_Notice_05_22_EN
    pdf, [554.48 kB]
    GP_HBV_Instruction for Use_EN
    pdf, [225.36 kB]
    GP_HBV_Manual de Uso_ES
    pdf, [208.12 kB]
    GP_HBV_Mode d'emploi_FR
    pdf, [225.12 kB]

    Declaration of Conformity

    GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]
    GP_HBV_Declaration of Conformity_EN
    pdf, [996.83 kB]
    GP_HBV_EC_Design_Examination_Certificate_EN
    pdf, [358.79 kB]

    MSDS

    GP_HBV_Safety_Data_Sheet_EN
    pdf, [278.5 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_HBV_Mic
    micassay, [13.84 kB]
    GP_HBV_template_AmpliLAB
    tlpi, [3.04 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_HBV_Leaflet_EN
    pdf, [134.48 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_CZ
    pdf, [2.5 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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