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    GeneProof Parvovirus B19 PCR Kit

    GeneProof B19 testing

    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_QCMD_2019_EN
    pdf, [186.38 kB]
    open
    GP_B19_QCMD_2020_EN
    pdf, [190.66 kB]
    open
    GP_Instand_03.2019_EN
    pdf, [303.02 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 (ISEX version)
    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
    SLAN® 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 CE IVD 

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.43 MB]
    GP_B19_Instruction for Use_EN
    pdf, [90.41 kB]
    GP_B19_Instruction for Use_ES
    pdf, [77.18 kB]
    GP_B19_Manual de Uso_SP
    pdf, [77.18 kB]

    Declaration of Conformity

    GP_B19_Declaration of Conformity_EN
    pdf, [266.02 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 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]

    Product Leaflet

    GP_B19_Leaflet_EN
    pdf, [175.28 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, [4.88 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]
    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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