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    GeneProof Borrelia PCR Kit

    CE IVD
    GeneProof Borrelia PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of the 16S rRNA gene
    • 100% diagnostic sensitivity

    WIDE RANGE OF VALIDATED CLINICAL MATERIALS

    • Plasma, serum, whole blood, CSF, urine and tick

    HIGH SPECIFICITY

    • 15 Borrelia burgdorferi sensu lato strains worldwide
    • Borrelia burgdorferi sensu stricto
    • Borrelia miyamotoi

    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

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Borrelia PCR Kit BOR/GP/025 real-time PCR 25 reactions
    GeneProof Borrelia PCR Kit BOR/GP/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_BOR_Leaflet_EN
    pdf, [139.25 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_BB_QCMD_12_20_EN
    pdf, [171.03 kB]
    open
    ; GP_BB_QCMD_09_21_EN_02
    pdf, [170.04 kB]
    open
    ; GP_BB_QCMD_09_21_EN_01
    pdf, [169.11 kB]
    open
    ; GP_BB_Instand_06_21_EN
    pdf, [901.17 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence Gene encoding 16S rRNA
    Analytical Specificity

    Borrelia burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, B. miyamotoi (Asian genotype), 100 %
    Analytical Sensitivity (LoD with 95% probability)

    0.568 cp/μl (on Amplirun® Borrelia burgdorferi DNA control, Vircell)
    Diagnostic Specificity 98.15 % (Cl95%: 88.82 % – 99.90 %)
    Diagnostic Sensitivity 100.00 % (Cl95%: 96.93 % – 100.00 %)
    Positive Predictive Value 99.35 % (Cl95%: 95.86 % – 99.97 %)
    Negative Predictive Value 100.00 % (Cl95%: 91.58 % – 100.00 %)
    Extraction / Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Control
    Validated Specimen CSF, plasma, serum, tick, urine, whole blood (EDTA)
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    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
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    StepOne™ / StepOne Plus™ Real-Time PCR System
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX/JOE/VIC
    External Quality Assessment Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_BOR_Advisory Notice_06_22_EN
    pdf, [821.57 kB]
    ; GP_BOR_Instruction_for_Use_EN
    pdf, [307.52 kB]
    ; GP_BOR_Instruction_for_Use_ES
    pdf, [301.12 kB]
    ; GP_BOR_Instruction_for_Use_FR
    pdf, [290.06 kB]
    ; GP_BOR_Instruction_for_Use_PT
    pdf, [111.4 kB]

    Declaration of Conformity

    ; GP_BOR_Declaration_of_Conformity_EN
    pdf, [607.96 kB]

    MSDS

    ; GP_BOR_Safety_Data_Sheet_EN
    pdf, [275.23 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]

    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_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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    FAQ

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