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    GeneProof Mycoplasma pneumoniae PCR Kit

    CE IVD
    GeneProof Mycoplasma pneumoniae PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY AND SPECIFICITY

    • Secured by targeting the multicopy sequence of the M181 gene

    EASY-TO-USE CONCEPT

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

    CONTAMINATION PREVENTION

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

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

     

    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 pneumoniae PCR Kit MP/ISEX/025 real-time PCR 25 reactions
    GeneProof Mycoplasma pneumoniae PCR Kit MP/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_MP_Instand_06_2021_EN
    pdf, [901.22 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 The M181 gene encoding the CARDS toxin
    Analytical Specificity

    M. pneumoniae, 100 % 
    Analytical Sensitivity (LoD with 95% probability)

    0.46 cp/μl
    Extraction/Inhibition Controls

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen BAL, sputum, swab
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    AMPLilab Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOne™ / StepOnePlus™ Real-Time PCR System
    Detection Channels FAM, HEX/JOE/VIC
    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_MP_Advisory_Notice_05_22_EN
    pdf, [790.15 kB]
    ; GP_MP_Instruction_for_Use_EN
    pdf, [286.07 kB]
    ; GP_MP_Instruction_for_Use_ES
    pdf, [141.7 kB]
    ; GP_MP_Instruction_for_Use_FR
    pdf, [138.38 kB]

    Declaration of Conformity

    ; GP_MP_Declaration_of_Conformity_EN
    pdf, [565.61 kB]

    MSDS

    ; GP_MP_ Safety_data_sheet_EN
    pdf, [275.72 kB]

    Publications

    ; GP_RESPIRATORY_Publications_10_2022_EN
    pdf, [142.69 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 pneumoniae_Mic
    micassay, [21.95 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    ; GP_MP_Leaflet_EN
    pdf, [140.59 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]
    ; LightCycler 2.0_EN
    pdf, [1.8 MB]
    ; LightCycler 480/480 Instrument II_EN
    pdf, [2.18 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]
    ; 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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