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    GeneProof Mycobacterium tuberculosis PCR Kit

    CE IVD
    GeneProof Mycobacterium tuberculosis PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • Secured by targeting the multi-copy sequence IS6110 found only in the species within the M. tuberculosis complex

    CONTAMINATION ELIMINATION

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

    HIGH SPECIFICITY

    • Detection of all species from Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti)

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Mycobacterium tuberculosis PCR Kit MT/ISEX/025 real-time PCR 25 reactions
    GeneProof Mycobacterium tuberculosis PCR Kit MT/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_MT_QCMD_11_21_EN_02
    pdf, [164.92 kB]
    open
    GP_MT_QCMD_11_21_EN_01
    pdf, [164.15 kB]
    open
    GP_MT_QCMD_10_20_EN_croBEE_02
    pdf, [127.55 kB]
    open
    GP_MT_QCMD_10_20_EN_croBEE_01
    pdf, [126.65 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis qualitative
    Target Sequence specific multi-copy insertion sequence IS6110
    Analytical Specificity

    Mycobacterium tuberculosis complex (M. tuberculosis, M. bovis, M. africanum, M. microti, M. caprae, M. canetti and vaccine strain BCG), 100%
    Analytical Sensitivity (LoD)

    reaches up to 0.191 cp/µl with the probability 95 % (on Amplirun® Mycobacterium tuberculosis DNA control, Vircell)
    Extraction / Inhibition Control

    PCR inhibition control (ISIN version)

    PCR inhibition and DNA extraction efficiency control (ISEX version)
    Validated Specimen

    BAL, CSF, sputum, stool, swab, urine
    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
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOne™ / StepOnePlus™ Real-Time PCR System
    Required Detection Channels FAM, HEX
    External Quality Control regularly tested by the 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, [1.55 MB]
    GP_MT_Instruction for Use_EN
    pdf, [544.22 kB]
    GP_MT_Manul de Uso_SP
    pdf, [143.15 kB]

    Declaration of Conformity

    GP_MT_Declaration of Change_EN_CZ
    pdf, [172.59 kB]
    GP_MT_Declaration of Conformity_EN
    pdf, [320.28 kB]

    MSDS

    GP_MT_Safety_Data_Sheet_EN
    pdf, [274.93 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_Mycobacterium tuberculosis_Mic
    micassay, [21.98 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_MT_Leaflet_EN
    pdf, [143.14 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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