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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 reagentsnecessary
    • 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/050 real-time PCR 50 reactions
    GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_HBV_QCMD_2020
    pdf, [195.24 kB]
    open
    GP_HBV_QCMD_C1.2018_EN
    pdf, [155.89 kB]
    open
    GP_HBV_QCMD_C3.2018_EN
    pdf, [176.05 kB]
    open
    GP_HBV_QCMD_croBEE_2019_EN
    pdf, [200.86 kB]
    open
    GP_Instand_03.2018_EN
    pdf, [1.21 MB]
    open
    GP_Instand_03.2019_EN
    pdf, [327.24 kB]
    open
    Choose all

    Technical specification

    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, pre-core mutants HBV  (HBeAg negative), 100% 
    Analytical Sensitivity (LoD) reaches up to 36.9792 IU/ml with the probability of 95 % (on HBV NIBSC 05/148 using manual extraction
    GeneProof PathogenFree DNA Isolation Kit)
    reaches up to 64.067 IU/ml with the probability of 95% (on HBV NIBSC 10/266 using automatic extractor
    croBEE NA16 Nucleic Acid Extraction System)
    reaches up to 13.9 IU/ml with the probability of 95% (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% : 99.90% – 100%)
    Linear Range

    1010 – 102 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation
    Kit or automatic extractor croBEE NA16 Nucleic Acid Extraction System)
    Dynamic Range

    1010 – 36.9792 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    1010 – 64.067 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
    Reporting Units

    IU/µl
    Conversion Factor

    Not applicable
    Metrological Traceability

    HBV NIBSC 10/264
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control (ISEX version)
    Validated Specimen plasma, serum
    Storage -20 ± 5 °C
    Validated Extraction Method croBEE NA16 Nucleic Acid Extraction System
    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
    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
    Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
    External Quality Assessment Regularly tested by QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com
    Certification CE1023 IVD 

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.45 MB]
    GP_HBV_Advisory Notice_EN_CZ
    pdf, [349.85 kB]
    GP_HBV_Instruction for Use_EN
    pdf, [106.44 kB]

    Declaration of Conformity

    GP_FQAS EC Certificate_EN
    pdf, [48.26 kB]
    GP_HBV_Declaration of Conformity_EN
    pdf, [345.57 kB]
    GP_HBV_FQAS EC Certificate_EN
    pdf, [512.77 kB]

    MSDS

    GP_HBV_Safety Data Sheet_EN
    pdf, [702.19 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, [1.94 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, [2.29 MB]
    QuantStudio 3/5 Real-Time PCR System_EN
    pdf, [2 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]

    Product Leaflet

    GP_HBV_Leaflet_EN
    pdf, [134.48 kB]

    PCR Template

    GP_HBV_Mic_1
    micassay, [13.84 kB]
    Files are available only for registered users.

    Order

    +420 543 211 679
    sales@geneproof.com

    Technical Support 

    Send request
    +420 730 176 222
    support@geneproof.com

    FAQ

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