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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 WITH LESS SAMPLES

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


    DETECTS porA MUTANT OF N. GONORRHOEAE

    • Dual target detection of 16S rRNA gene and porA pseudogene

    SWEDISH VARIANT OF C. TRACHOMATIS

    • Dual target detection of 16S rRNA gene and cryptic plasmid

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of 16S rRNA for all three detected pathogens

    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 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_09_20_EN
    pdf, [177.19 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
    GP_NG_CNMX_QCMD_2020_EN
    pdf, [124.97 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 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)

    reaches up to 0.177 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell)
    reaches up to 0.22 cp/μl with the probability of 95 % (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
    reaches up to 1.129 cp/μl with the probability of 95 % (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%)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen 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 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
    Required Detection Channels FAM, HEX, Cy5, Texas Red
    External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
    Certification CE1023 IVD 

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_CNMX_Advisory Notice_EN_CZ
    pdf, [265.33 kB]
    GP_CNMX_Instruction for Use_EN
    pdf, [91.66 kB]

    Declaration of Conformity

    GP_CNMX_Declaration of Conformity_EN
    pdf, [322.37 kB]
    GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]

    MSDS

    GP_CNMX_Safety_Data_Sheet_EN
    pdf, [274.67 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, [142.53 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]
    croBEE Real-Time PCR System_EN
    pdf, [5.9 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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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

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