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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 detection failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
    • Detection of all HBV genotypes A – H
    • 100% diagnostic specificity

    HIGH SENSITIVITY

    • Ensures excellent sensitivity up to 13.9 IU/ml
    • 100% diagnostic sensitivity

    W.H.O. STANDARD BASED QUANTIFICATION

    • Precise and fully traceable quantification according to 4th WHO International Standard NIBSC 10/266

    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

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

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE1023IVD 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_8_22_EN
    pdf, [182.98 kB]
    open
    ; GP_HBV_QCMD_04_22_EN
    pdf, [188.4 kB]
    open
    ; GP_HBV_Instand_03_22_EN
    pdf, [1.06 MB]
    open
    ; GP_HBV_QCMD_08_21_EN
    pdf, [189.09 kB]
    open
    ; GP_HBV_Instand_03_21_EN
    pdf, [1.02 MB]
    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),
    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/ml
    Metrological Traceability

    HBV NIBSC 10/266 (4th WHO International Standard)
    Validated Specimen Plasma, serum
    Storage -20 ± 5 °C
    Validated Extraction Method croBEE 201A 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 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_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, [604.59 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, [141.88 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_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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    Customer Support 

    Send request
    +420 730 176 222
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