Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching
    • /
    • search

    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/050 real-time PCR 50 reactions
    GeneProof Cytomegalovirus (CMV) PCR Kit CMV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_CMV_QCMD_2019_EN
    pdf, [221.38 kB]
    open
    GP_CMV_QCMD_C1.2018_EN
    pdf, [220.37 kB]
    open
    GP_CMV_QCMD_C3.2018_EN
    pdf, [217.65 kB]
    open
    GP_Instand_03.2018_EN
    pdf, [1.21 MB]
    open
    GP_Instand_03.2019_EN
    pdf, [326.84 kB]
    open
    Choose all

    Technical specification

    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) reaches up to 122.594 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 using manual extraction
    GeneProof PathogenFree DNA Isolation Kit)
    reaches up to 165.237 IU/ml with the probability of 95 % (on CMV NIBSC 09/162 using automatic extraction
    croBEE NA16 Nucleic Acid Extraction System)
    Diagnostic Specificity 90.67% (CI95%: 81.15% – 95.85%)
    Diagnostic Sensitivity 92.86% (CI95%: 64.17% – 99.63%)
    Linear Range  1010 – 102.5 cp/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation
    Kit or automatic extraction croBEE NA16 Nucleic Acid Extraction System)
    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 System)
    Reporting Units cp/µl
    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, whole blood, urine*
    *validated only on manual extraction GeneProof PathogenFree DNA Isolation Kit
    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 7300 / 7500 Real-Time PCR System
    AriaMx 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 / 5 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
    Certification CE1023 IVD

    *Validated instruments

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.45 MB]
    GP_CMV_Advisory Notice_EN_CZ
    pdf, [266.81 kB]
    GP_CMV_Instruction for Use_EN
    pdf, [109.06 kB]
    GP_CMV_Instruction for Use_ES
    pdf, [95.91 kB]

    Declaration of Conformity

    GP_CMV_Declaration of Conformity_EN
    pdf, [321.94 kB]
    GP_FQAS EC Certificate_EN
    pdf, [48.26 kB]

    MSDS

    GP_CMV_Safety Data Sheet_EN
    pdf, [718.9 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, [1.94 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, [2.29 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]

    Product Leaflet

    GP_CMV_Leaflet_EN
    pdf, [161.91 kB]

    PCR Template

    GP_CMV_Mic_1
    micassay, [13.83 kB]
    Files are available only for registered users.

    Order

    +420 543 211 679
    sales@geneproof.com

    Technical Support 

    Send request
    +420 730 176 222
    support@geneproof.com

    FAQ

    News

    Czech Embassy in New Delhi to congratulate GeneProof on success

    GeneProof as first Czech company given rights to supply COVID-19 kits to India.

    New Covid-19 • Flu • RSV GPack

    Differential diagnostics of 5 pathogens from one sample in a single run

    more