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    GeneProof Borrelia burgdorferi PCR Kit

    CE IVD
    GeneProof Borrelia burgdorferi PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of the 16S rRNA gene

    WIDE RANGE OF VALIDATED CLINICAL MATERIALS

    • Validated specimen: plasma, serum, whole blood, CSF, urine and tick

    HIGH SPECIFICITY

    • Detection of all Borrelia burgdorferi sensu lato strains worldwide
    • B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. miyamotoi, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii

    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 Borrelia burgdorferi PCR Kit BB/ISEX/025 real-time PCR 25 reactions
    GeneProof Borrelia burgdorferi PCR Kit BB/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_BB_QCMD_2017
    pdf, [149.35 kB]
    open
    GP_BB_QCMD_2018_EN
    pdf, [148.35 kB]
    open
    GP_BB_QCMD_2019_EN
    pdf, [167.67 kB]
    open
    GP_Instand_06.2018_EN
    pdf, [617.11 kB]
    open
    GP_Instand_06.2019_EN
    pdf, [416.54 kB]
    open
    GP_Instand_06.2020_EN
    pdf, [323.72 kB]
    open
    Choose all

    Technical specification

    Technology real-time PCR
    Type of Analysis qualitative
    Target Sequence the gene sequence encoding 16S rRNA
    Specificity

    B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. miyamotoi, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, 100 %
    Sensitivity (LoD)

    reaches up to 0.568 cp/μl with the probability of 95 % (on Amplirun® Borrelia burgdorferi DNA control, Vircell)
    Extraction / Inhibition Control

    PCR Inhibition and DNA extraction efficiency control 
    Validated Specimen CSF, plasma, serum, tick, urine, whole blood
    Storage -20 ± 5 °C
    Validated Extraction Methods 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
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 / Q
    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

    *Validated instruments

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.49 MB]
    GP_BB_Instruction for Use_EN
    pdf, [545.28 kB]
    GP_BB_Manual de Uso_SP
    pdf, [154.27 kB]
    GP_Declaration of Change_EN_CZ
    pdf, [209.66 kB]

    Declaration of Conformity

    GP_BB_Declaration of Conformity_EN
    pdf, [312.72 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 kB]

    PCR Template

    GP_Borrelia burgdorferi_Mic
    micassay, [21.97 kB]
    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]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_BB_Leaflet_EN
    pdf, [152.84 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 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_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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