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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

    UNIVERSAL PCR PROFILE

    • Easily combinable with other PCR Kits from the STI group
    • Simplifies laboratory workflow

    HIGH SENSITIVITY

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

    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 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

    EQA Panels

    EQA results

    GP_MGH_QCMD_09_20_EN
    pdf, [177.19 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
    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 NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX Connect™ * / CFX96™/ Dx Real-Time PCR Detection System
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 * / Q
    QuantStudio™ 3 / 5 Real-Time PCR System *
    StepOne™ / StepOnePlus™ Real-Time PCR System *
    SLAN® Real-Time PCR System
    Required Detection Channels

    FAM, HEX, Cy5
    External Quality Assessment regularly tested by QCMD External Quality Assessment Panels - results at www.geneproof.com
    Regulatory Status CE IVD 

    * The kit requires three detection channels. On instruments with two detection channels the kit detects the M. genitalium presence only.

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_Declaration of Change_EN_CZ
    pdf, [209.66 kB]
    GP_MGH_Instruction for Use_EN
    pdf, [553.2 kB]

    Declaration of Conformity

    GP_MGH_Declaration of Conformity_EN
    pdf, [615.92 kB]

    MSDS

    GP_MGH_Safety_Data_Sheet_EN
    pdf, [303.09 kB]

    Publications

    STI_publications
    pdf, [254.48 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]

    Product Leaflet

    GP_MGH_Leaflet_EN
    pdf, [135.29 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]
    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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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

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