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    GeneProof Parvovirus B19 PCR Kit

    CE IVD
    GeneProof Parvovirus B19 PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY AND TRACEABILITY

    • Sensitivity was established with certified strain (NIBSC 3rd WHO International standard 12/208)

    PRECISE QUANTITATIVE DETECTION

    • Precise and fully traceable quantification according NIBSC 3rd WHO International standard 12/208

    CONTAMINATION ELIMINATION

    • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Parvovirus B19 PCR Kit B19/ISEX 025 real-time PCR 25 reactions
    GeneProof Parvovirus B19 PCR Kit B19/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_B19_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    GP_B19_Instand_04_20_EN
    pdf, [909.45 kB]
    open
    GP_B19_Instand_06_21_EN
    pdf, [1 MB]
    open
    GP_B19_QCMD_2019_EN
    pdf, [186.38 kB]
    open
    GP_B19_QCMD_2020_EN
    pdf, [190.66 kB]
    open
    Choose all

    Technical specification

    Technology real-time PCR
    Type of Analysis qualitative and quantitative
    Target Sequence specific conservative DNA sequence of a single copy gene encoding VP1 protein (capsid protein)
    Analytic Specificity

    Parvovirus B19, 100 %
    Analytic Sensitivity (LoD) reaches up to 90.29 IU/ml with the probability of 95 % (on Parvovirus B19 NIBSC 12/208 using manual
    extraction GeneProof PathogenFree DNA Isolation Kit)
    reaches up to 156.7 IU/ml with the probability of 95 % (on Parvovirus B19 NIBSC 12/208 using automatic
    extraction croBEE NA16 Nucleic Acid Extraction System)
    Linear Range  108 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation
    Kit or automatic extraction croBEE NA16 Nucleic Acid Extraction System)
    Dynamic Range  108 – 90.29 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    108 – 156.7 IU/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction System)
    Reporting Units IU/μl
    Conversion Factor 1 IU = 1.6 cp
    Metrological Tracebility  Parvovirus B19 NIBSC 12/208
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
    Validated Specimen plasma, whole blood
    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
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LightCycler 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 / Q
    QuantStudio™ 3 / 5 Real-Time PCR System
    StepOne™ / StepOnePlus™ Real-Time PCR System
    SLAN® 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
    Certification 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_B19_Instruction for Use_EN
    pdf, [231.82 kB]
    GP_B19_Instruction for Use_ES
    pdf, [250.63 kB]
    GP_B19_Instruction for Use_FR
    pdf, [267.1 kB]

    Declaration of Conformity

    GP_B19_Declaration of Conformity_EN
    pdf, [266.02 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_Parvovirus_Mic
    micassay, [22.29 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_B19_Leaflet_EN
    pdf, [175.28 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 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]
    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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