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    GeneProof CT/NG/MG Multiplex PCR Kit

    CE 1023 IVD
    GeneProof CT/NG/MG Multiplex PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION FROM ONE REACTION

    • PCR Kit detects and distinguishes the most important STI pathogens in a single reaction tube:
      Chlamydia trachomatis
      Neisseria gonorrhoeae
      Mycoplasma genitalium

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other PCR kits from the STI Panel in one workflow

    EASY-TO-USE CONCEPT

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

    HIGH SENSITIVITY

    • Detects porA mutant of Neisseria gonorrhoeae and Swedish variant of Chlamydia trachomatis
    • Secured by targeting the multicopy sequence of 16S rRNA for all three detected pathogens

    CONTAMINATION PREVENTION

    • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE1023IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/025 real-time PCR 25 reactions
    GeneProof CT/NG/MG Multiplex PCR Kit CNMX/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_CNMX_QCMD_05_22_EN_04
    pdf, [124.39 kB]
    open
    ; GP_CNMX_QCMD_05_22_EN_03
    pdf, [126.99 kB]
    open
    ; GP_CNMX_QCMD_05_22_EN_02
    pdf, [131.63 kB]
    open
    ; GP_CNMX_QCMD_05_22_EN_01
    pdf, [129.19 kB]
    open
    ; GP_NG_QCMD_09_21_EN_02
    pdf, [125.32 kB]
    open
    ; GP_NG_QCMD_09_21_EN_01
    pdf, [122.7 kB]
    open
    ; GP_MG_QCMD_09_21_EN
    pdf, [183.1 kB]
    open
    ; GP_CHT_QCMD_09_21_EN_02
    pdf, [138.45 kB]
    open
    ; GP_CHT_QCMD_09_21_EN_01
    pdf, [136.05 kB]
    open
    ; GP_CTNG_QCMD_09_21_EN_04
    pdf, [140 kB]
    open
    ; GP_CTNG_QCMD_09_21_EN_03
    pdf, [139.96 kB]
    open
    ; GP_CTNG_QCMD_09_21_EN_01
    pdf, [140.79 kB]
    open
    ; GP_NG_Instand_06_21_EN
    pdf, [901.17 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE1023IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target sequence The cryptic plasmid sequence and the 16S rRNA gene for Chlamydia trachomatis
    The 16S rRNA gene and porA pseudogene for Neisseria gonorrhoeae
    The 16S rRNA gene for Mycoplasma genitalium
    Analytical Specificity Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium, 100 %
    Analytical Sensitivity (LoD with 95% probability)

    0.177 cp/μl (on Amplirun® Chlamydia trachomatis DNA control, Vircell)
    0.22 cp/μl (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
    1.129 cp/μl (on Amplirun® Mycoplasma genitalium DNA control, Vircell)
    Diagnostic specificity 96.89% (CI95%: 93.04% – 98.73%)
    Diagnostic sensitivity 97.67 % (CI95%: 86.20% – 99.88%)
    Validated Specimen Swab, urine
    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 7500 Real-Time PCR System
    CFX96™/ Dx Real-Time PCR Detection System
    Mic qPCR Cycler
    QuantStudio™ 5 Real-Time PCR System
    AriaMx Real-Time PCR System
    LineGene 9600 Plus
    Rotor-Gene 3000 / Q
    Detection Channels FAM, HEX, Cy5, Texas Red
    External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com

    Documentation

    Instruction for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_CNMX_Advisory Notice_EN_CZ
    pdf, [265.33 kB]
    ; GP_CNMX_Advisory_Notice_05_22_EN
    pdf, [440.49 kB]
    ; GP_CNMX_Instruction_for_Use_EN
    pdf, [209.18 kB]
    ; GP_CNMX_Instruction_for_Use_ES
    pdf, [234.4 kB]
    ; GP_CNMX_Instruction_for_Use_FR
    pdf, [233.1 kB]

    Declaration of Conformity

    ; GP_CNMX_Declaration_of_Conformity_EN
    pdf, [618.12 kB]
    ; GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]

    MSDS

    ; GP_CNMX_Safety_Data_Sheet_EN
    pdf, [273.93 kB]

    PCR Template

    ; GP_CNMX_Mic
    micassay, [19.87 kB]
    ; GP_CNMX_template_AmpliLAB
    tlpi, [3.53 kB]
    ; GP_DNA_4CH_ABI7500
    edt, [10.36 kB]
    ; GP_DNA_4CH_AriaMx
    amxt, [3.72 kB]
    ; GP_DNA_4CH_croBee
    fqt, [4.94 kB]
    ; GP_DNA_4CH_QS5
    edt, [8.21 kB]
    ; GP_DNA_BioRad
    prcl, [1.33 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    ; GP_CNMX_Leaflet_EN
    pdf, [130.86 kB]
    ; GP_CNMX_Poster_EN
    pdf, [101.38 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]
    ; 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]
    ; 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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