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    GeneProof Mycoplasma genitalium/hominis PCR Kit

    CE IVD
    GeneProof Mycoplasma genitalium/hominis PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION WITH LESS SAMPLES

    • Enables to distinguish Mycoplasma hominis from Mycoplasma genitalium using 3-channel system

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of the 16S rRNA gene of Mycoplasma genitalium

    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 Mycoplasma genitalium/hominis PCR Kit MGH/ISEX/025 real-time PCR 25 reactions
    GeneProof Mycoplasma genitalium/hominis PCR Kit MGH/ISEX/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_STI_Panel_Leaflet_EN
    pdf, [1.42 MB]
    open
    ; GP_MGH_Leaflet_EN
    pdf, [126.9 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_STI_I_QCMD_croBEE_11_2022_EN
    pdf, [246.42 kB]
    open
    ; GP_STI I_QCMD_11_2022_EN
    pdf, [261.07 kB]
    open
    ; GP_MG_QCMD_09_21_EN_02
    pdf, [182.21 kB]
    open
    ; GP_MG_QCMD_09_21_EN_01
    pdf, [184.16 kB]
    open
    ; GP_MG_Instand_06_21_EN
    pdf, [901.27 kB]
    open
    ; GP_MGH_croBEE_QCMD_11_2020_EN
    pdf, [182.89 kB]
    open
    ; GP_MGH_QCMD_11_2020_EN
    pdf, [180.92 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

    A multicopy sequence of the gene encoding the 16S rRNA (M. genitalium) and the housekeeping gap gene for glyceraldehyde-3-phosphate dehydrogenase (M.hominis)
    Analytical Specificity

    M. genitalium, 100 %
    M. hominis, 100 %
    Analytical Sensitivity (LoD)

    Reaches up to 1.256 cp/μl with the probability of 95 % for M. genitalium
    Reaches up to 1.196 cp/μl with the probability of 95 % for M. hominis
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
    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
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ Real-Time PCR Detection System *
    CFX96™ / Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudioTM 3 Real-Time PCR System *
    QuantStudioTM 5 Real-Time PCR System
    Rotor-Gene 3000 / Q
    Rotor-Gene 6000 *
    SLAN® Real-Time PCR System
    StepOneTM / StepOne PlusTM Real-Time PCR System *
    Required Detection Channels

    FAM, HEX, Cy5
    External Quality Assessment Regularly tested in QCMD External Quality Assessment Panels - results at www.geneproof.com

    * The device allows detection of M. genitalium only.

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_MGH_Advisory_Notice_11_22_EN
    pdf, [816.45 kB]
    ; GP_MGH_Advisory_Notice_1_23_EN
    pdf, [415.07 kB]
    ; GP_MGH_Instruction_for_Use_EN
    pdf, [110.75 kB]
    ; GP_MGH_Instruction_for_Use_IT
    pdf, [144.12 kB]

    Declaration of Conformity

    ; GP_MGH_Declaration_of_Conformity_EN
    pdf, [571.56 kB]

    MSDS

    ; GP_MGH_Safety_Data_Sheet_EN
    pdf, [303.09 kB]

    Publications

    ; GP_STI_publications_08_22_EN
    pdf, [204.33 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_Mycoplasma genitalium_hominis_Mic
    micassay, [26.61 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]
    ; 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]
    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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