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    GeneProof Cytomegalovirus (CMV) PCR Kit

    CE 1023 IVD
    GeneProof Cytomegalovirus (CMV) PCR Kit

    PRODUCT ADVANTAGES

     

    DETECTION OF ALL CMV GENOTYPES

    • The kit detects all genotypes of Cytomegalovirus including genotypes GB1-GB4

    FULL TRACEABILITY WITH WHO STANDARDS

    • Sensitivity was established with WHO certified strain (1st WHO International StandardNIBSC 09/162)
    • Precise and fully traceable quantification according to NIBSC 09/162

    CONTAMINATION ELIMINATION

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

    EXCELLENT EQA PANEL RESULTS

    • Very high diagnostic sensitivity (up to 99.5 % on core samples) and specificity (100 %) confirmed by analysis of QCMD panel reports from 2008 to present

    UNIVERSAL PCR PROFILE

    • Easily combinable with other PCR kits from the Immunocompromised / Transplanted group
    • Simplifies laboratory 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 Cytomegalovirus (CMV) PCR Kit CMV/ISEX/025 real-time PCR 25 reactions
    GeneProof Cytomegalovirus (CMV) PCR Kit CMV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_Transplatation_QCMD_01_22_EN
    pdf, [200.17 kB]
    open
    GP_CMV_QCMD_10_21_EN
    pdf, [237.23 kB]
    open
    GP_CMV_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE1023IVD
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis qualitative and quantitative
    Target Sequence specific conservative DNA sequence of a single copy gene encoding the 4 IE antigen
    Analytical Specificity Human Cytomegalovirus (CMV), 100 %
    Analytical Sensitivity
    (LoD with the probability of 95 %)    		 122.594 IU/ml (on CMV NIBSC 09/162, manual extraction GeneProof PathogenFree DNA Isolation Kit)
    165.237 IU/ml (on CMV NIBSC 09/162, automatic extraction croBEE 201A Nucleic Acid Extraction Kit)
    Diagnostic Specificity 90.67% (CI95%: 81.15% – 95.85%)
    Diagnostic Sensitivity 92.86% (CI95%: 64.17% – 99.63%)
    Linear Range  1010 - 102.5 IU/ml with precision of ± 0.5 log
    Dynamic Range 1010 – 122.594 cp/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    1010 – 165.237 cp/ml (using automatic extraction croBEE NA16 Nucleic Acid Extraction Kit)
    Reporting Units U/ml
    Conversion factor 1 IU = 1 cp
    Metrological Traceability CMV NIBSC 09/162
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
    Validated Specimen

    plasma, serum, urine*, whole blood
    Storage

    -20 ± 5 °C
    Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOne™ / StepOnePlus™ Real-Time PCR System
    Required Detection Channels FAM, HEX
    External Quality Assessment Regularly tested by  QCMD and Instand e.V. External Quality Assessment Panels -results at www.geneproof.com

    *NOTE: Validated only on manual extraction GeneProof PathogenFree DNA Isolation Kit.

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_CMV_ Mode d´emploi_FR
    pdf, [267.92 kB]
    GP_CMV_Advisory Notice_EN_CZ
    pdf, [266.81 kB]
    GP_CMV_Advisory_Notice_05_22_EN
    pdf, [566.08 kB]
    GP_CMV_Instruction for Use_EN
    pdf, [235.12 kB]
    GP_CMV_Manual de Uso_ES
    pdf, [220.07 kB]

    Declaration of Conformity

    GP_CMV_Declaration of Conformity_EN
    pdf, [321.94 kB]
    GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]

    MSDS

    GP_CMV_Safety_Data_Sheet_EN
    pdf, [278.57 kB]

    PCR Template

    GP_CMV_Mic
    micassay, [13.83 kB]
    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]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_CMV_Leaflet_EN
    pdf, [161.91 kB]
    GP_IT_Panel_Leaflet_EN
    pdf, [275.02 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]
    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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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

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