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    GeneProof Mycobacterium tuberculosis PCR Kit

    CE IVD
    GeneProof Mycobacterium tuberculosis PCR Kit

    PRODUCT ADVANTAGES

     

    DUAL TARGET DETECTION

    • Dual targeting prevents detection failures caused by occurrence of mutations
    • Secured by targeting the multi-copy sequence IS6110 and MPB64

    HIGH SPECIFICITY

    • Detection of all species from Mycobacterium tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. microti, M. canetti, M. caprae, M. orygis, M. mundi and vaccination strain Bacillus Calmmette-Guérin, BCG)

    WIDE RANGE OF VALIDATED CLINICAL MATERIALS

    • Enables detection from a broad spectrum of respiratory and gastrointestinal samples
    • Sputum, BAL, swab, urine, CSF, plasma, stool

    EASY-TO-USE CONCEPT

    • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary
    • Simplifies laboratory workflow

    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 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

    Product Leaflet

    Product Leaflet

    ; GP_MT_Leaflet_EN
    pdf, [145 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_MT_QCMD_05_22_EN_02
    pdf, [134.43 kB]
    open
    ; GP_MT_QCMD_05_22_EN_01
    pdf, [133.57 kB]
    open
    ; 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
    Regulatory Status CE IVD
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence Multi-copy insertion sequence IS6110 and sequence for immunogenic protein MPB64
    Analytical Specificity

    Mycobacterium tuberculosis complex (M. tuberculosis, M. africanum, M. bovis, M. microti, M. canettii, M. pinnipedi, M. caprae, M. orygis, M. mungi and vaccination strain Bacillus Calmette–Guérin, BCG), (MT) 100 %

    Analytical Sensitivity (LoD with 95% probability)

    0.09 cp/µl (performed on AmpliRun® Mycobacterium tuberculosis DNA control, Vircell)
    Extraction / Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Control (IC)
    Validated Specimen

    Sputum, BAL, swab, urine, CSF, plasma, stool
    Storage

    -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit 
    myCROBE/croBEE 2.0 Universal Extraction Kit
    QIAamp Fast Stool Mini 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
    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
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX/JOE/VIC
    External Quality Control Regularly tested in the 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_MT_Advisory_Notice_06_22_EN
    pdf, [1.05 MB]
    ; GP_MT_Instructions_for_Use_IT
    pdf, [144.53 kB]
    ; GP_MT_Instruction_for_Use_EN
    pdf, [110.61 kB]
    ; GP_MT_Instruction_for_Use_ES
    pdf, [108.52 kB]

    Declaration of Conformity

    ; GP_MT_Declaration of Change_EN_CZ
    pdf, [172.59 kB]
    ; GP_MT_Declaration_of_Conformity_EN
    pdf, [622.69 kB]

    MSDS

    ; GP_MT_Safety_Data_Sheet_EN
    pdf, [274.93 kB]

    Publications

    ; GP_RESPIRATORY_Publications_10_2022_EN
    pdf, [142.69 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]

    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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