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

     

    W.H.O. STANDARD BASED QUANTIFICATION

    • Precise and fully traceable quantification according to 1st WHO International Standard NIBSC 09/162

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

    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

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

     

    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_CMV_Instand_03_22_EN
    pdf, [1.06 MB]
    open
    ; 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 IU/ml
    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, [1.61 MB]
    ; 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_Instruction_for_Use_FR
    pdf, [99.68 kB]
    ; GP_CMV_Instruction_for_Use_FR
    pdf, [99.68 kB]
    ; GP_CMV_Instruction_for_Use_IT
    pdf, [76.92 kB]
    ; GP_CMV_Manual de Uso_ES
    pdf, [220.07 kB]

    Declaration of Conformity

    ; GP_CMV_Declaration_of_Conformity_EN
    pdf, [581.06 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, [158.34 kB]
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 kB]
    ; GP_Transplatation_QCMD_01_22_EN
    pdf, [200.17 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
    [obfuscate_1_|114|88|105|98|112|63|94|98|107|98|111|105|108|108|99|45|90|108|106]

    Customer Support 

    Send request
    +420 730 176 222
    [obfuscate_1_|114|108|109|109|108|113|107|61|100|98|109|92|109|111|108|110|93|43|96|108|108]

    FAQ

    News

    The biggest myths about IVDR

    Do you know the biggest myths that are connected with the new IVD Regulation?

    IVDR products available!

    All our Class „A“ products are now IVDR certified as required since May, 2022. Let’s see our offer!

    more