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    GeneProof MRSA PCR Kit

    CE IVD
    GeneProof MRSA PCR Kit

    PRODUCT ADVANTAGES

     

    WIDE RANGE OF MRSA CHROMOSOMAL CASSETTE DETECTION

    • Detects MRSA chromosomal cassettes I. – XI.

    MULTI TARGET DETECTION

    • Enables testing both mecA / mecC genes
    • Recognizes empty cassettes

    CONTAMINATION ELIMINATION

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

    DIRECT DETECTION FROM CLINICAL MATERIAL

    • No need of previous cultivation
    • Quick result from primary clinical material

    UNIVERSAL PCR PROFILE

    • Easily combinable with e.g. GeneProof VRE PCR Kit

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof MRSA PCR Kit MRSA/ISEX/025 real-time PCR 25 reactions
    GeneProof MRSA PCR Kit MRSA/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_MRSA_QCMD_06_21_EN
    pdf, [175.79 kB]
    open
    GP_MRSA_QCMD_06_20_EN_croBEE
    pdf, [175.62 kB]
    open
    GP_MRSA_QCMD_06_20_EN
    pdf, [174.67 kB]
    open
    GP_MRSA_Instand_06_2021_EN
    pdf, [901.22 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

    nuc gene, which is specific for Staphylococcus aureus 
    SCCmec/orfX junction region
    resistance gene mecA/mecC
    Analytical Specificity

    Methicillin-Resistant Staphylococcus aureus (MRSA)
    Analytical Sensitivity (LoD)

    reaches up to 2.81 ge/µl with the probability of 95 % (on NCTC strain 13142)
    Extraction/Inhibition Control

    PCR Inhibition and DNA extraction efficiency control 

    Validated specimen

    		 aspirate, sputum, 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
    AriaMx Real-Time PCR System
    CFX96™ / Dx Real-Time PCR Detection System
    LineGene 9600 / 9600 Plus
    QuantStudio™ 5 Real-Time PCR System
    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 CE IVD

    *Validated instrument

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_MRSA_Advisory Notice_EN_CZ
    pdf, [191.76 kB]
    GP_MRSA_Instruction for Use_EN
    pdf, [1.03 MB]

    Declaration of Conformity

    GP_MRSA_Declaration of Conformity_EN
    pdf, [329.21 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]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_MRSA_Leaflet_EN
    pdf, [155.1 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]
    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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