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    GeneProof MH/UU/UP Multiplex PCR Kit

    CE IVD
    GeneProof MH/UU/UP Multiplex PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION FROM ONE REACTION

    • PCR Kit detects and distinguishes the important STI pathogens in a single reaction tube:
      Mycoplasma hominis
      Ureaplasma urealyticum
      Ureaplasma parvum

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

    CONTAMINATION PREVENTION

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

    EASY-TO-USE CONCEPT

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

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof MH/UU/UP Multiplex PCR Kit MUPX/GP/025 real-time PCR 25 reactions
    GeneProof MH/UU/UP Multiplex PCR Kit MUPX/GP/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_MUPX_QCMD_09_20_EN
    pdf, [177.19 kB]
    open
    ; GP_MUPX_Instand_06_21_EN
    pdf, [901.27 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 gap gene (M. hominis)
    UreD gene (U. urealyticum, U. parvum)
    Analytical Specificity Mycoplasma hominis, Ureaplasma urealyticum, Ureaplasma parvum, 100 %
    Analytical Sensitivity (LoD with 95% probability)

    0.84 cp/μl (on Amplirun® Mycoplasma hominis DNA control, Vircell)
    1.48 cp/μl (on Amplirun® Ureaplasma urealyticum DNA control, Vircell) 
    0.73 cp/μl (on synthetic DNA ultramer control Ureaplasma parvum)
    Diagnostic Specificity 96.00 % (CI95%: 87.97 % - 98.96 %) Mycoplasma hominis
    98.67 % (CI95%: 91.79 % - 99.93 %) Ureaplasma urealyticum
    100.00 % (CI95 %: 92.13% - 100.00 %) Ureaplasma parvum
    Diagnostic Sensitivity  87.50 % (CI95 %: 60.41% - 97.80 %) Mycoplasma hominis
    93.75 % (CI95 %: 67.71% - 99.67 %) Ureaplasma urealyticum
    100.00 % (CI95 %: 87.36% - 100.00 %) Ureaplasma parvum
    Positive Predictive Value  82.35 % (CI95%: 55.80 % - 95.33 %) Mycoplasma hominis
    93.75 % (CI95%: 67.71 % - 99.67 %) Ureaplasma urealyticum
    100.00 % (CI95%: 87.36 % - 100.00 %) Ureaplasma parvum
    Negative Predictive Value  97.30 % (CI95%: 89.69 % - 99.53 %) Mycoplasma hominis
    98.67 % (CI95%: 91.79 % - 99.93 %) Ureaplasma urealyticum
    100.00 % (CI95%: 92.13 % - 100.00 %) Ureaplasma parvum
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen Swab, urine, transport medium: UTM® Viral Transport (COPAN Diagnostics Inc.)
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    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
    Gentier 96E/96R Real-Time PCR System
    LineGene 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 5 Real-Time PCR System
    Required 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, [1.6 MB]
    ; GP_MUPX_Advisory_Notice_EN
    pdf, [867.95 kB]
    ; GP_MUPX_Instruction for Use_EN
    pdf, [285.81 kB]
    ; GP_MUPX_Instruction_for_Use_ FR
    pdf, [275.19 kB]

    Declaration of Conformity

    ; GP_MUPX_Declaration_of_Conformity_EN
    pdf, [599.29 kB]

    PCR Template

    ; 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]
    ; GP_MH_UU_UP_Mic
    micassay, [30.87 kB]

    Product Leaflet

    ; GP_MUPX_Leaflet_EN
    pdf, [121.74 kB]

    Manual

    ; 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]
    ; 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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