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    GeneProof Enterovirus PCR Kit

    CE IVD
    GeneProof Enterovirus PCR Kit

    PRODUCT ADVANTAGES

     

    COMPLIANCE WITH ENPEN REQUIREMENTS

    • Amplification of a single-copy 5‘ UTR RNA sequence which is required as the target sequence by European non-polio enterovirus network (ENPEN)
    • Suitable for using as primary screening method

    DETECTION OF ALL HUMAN ENTEROVIRUS SPECIES

    • The kit enables detection of Enterovirus species A-D including Coxsackievirus, Echovirus, Enterovirus, Poliovirus and the newly discovered Enterovirus group EV-C104 with nucleotide changes in 5´-UTR sequence.
    • The kit does not include Rhinovirus detection

    QUALITATIVE AND SEMIQUANTITATIVE DETECTION

    • Monitoring of pathogen level in time

    CONTAMINATION ELIMINATION

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

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

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

    EQA Panels

    EQA results

    GP_EV_Instand_06_21_EN
    pdf, [1 MB]
    open
    GP_EV_QCMD_08_21_EN
    pdf, [129.5 kB]
    open
    GP_EV_QCMD_08_21_EN
    pdf, [129.65 kB]
    open
    GP_EV_QCMD_05_21_EN
    pdf, [130.94 kB]
    open
    GP_EV_QCMD_05_21_EN
    pdf, [130.76 kB]
    open
    GP_EV_QCMD_11_20_EN
    pdf, [130.69 kB]
    open
    GP_EV_QCMD_11_20_EN
    pdf, [130.86 kB]
    open
    GP_EV_QCMD_05_20_EN
    pdf, [128.19 kB]
    open
    GP_EV_Instand_06_21_EN
    pdf, [1 MB]
    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 and semiquantitative
    Target sequence specific single copy 5‘ UTR RNA sequence
    Analytical Specificity Enterovirus A-D, 100 %
    Analytical Sensitivity (LoD)

    reaches up to 158.34 cp/μl with the probability of 95 % (on Amplirun® Enterovirus 68 RNA control, Vircell)
    reaches up to 0.57 cp/μl with the probability of 95 % (on Amplirun® Enterovirus 71 RNA control, Vircell)
    reaches up to 0.59 cp/μl with the probability of 95 % (on Amplirun® Coxsackie B5 RNA control, Vircell)
    Diagnostic Specificity 100.00% (CI95%: 93.75% - 100.00%)
    Diagnostic Sensitivity 93.75% (CI95%: 90.63% - 96.88%)
    Reporting Units cp/μl
    Extraction/Inhibition Control

    PCR inhibition and RNA extraction efficiency control 
    Validated Specimen CSF, stool*, swab
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree RNA Isolation Kit
    NucleoSpin® RNA Stool
    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® 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 / Q
    SLAN® 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 CE IVD 

    *Only in combination with NucleoSpin® RNA Stool or croBEE NA16 Nucleic Acid Extraction System

    ** Validated instruments

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_EV_ Instucton for Use_EN
    pdf, [242.83 kB]
    GP_EV_Advisory_Notice_CZ_EN
    pdf, [195.57 kB]

    Declaration of Conformity

    GP_EV_Declaration of Conformity_EN
    pdf, [310.72 kB]

    MSDS

    GP_EV_Safety_Data_Sheet_EN
    pdf, [277.92 kB]

    PCR Template

    GP_Enterovirus_Mic
    micassay, [21.92 kB]
    GP_UNI_3CH_2CH_ABI7500
    edt, [10.33 kB]
    GP_UNI_3CH_2CH_AriaMx
    amxt, [3.64 kB]
    GP_UNI_3CH_2CH_CroBee
    fqt, [4.9 kB]
    GP_UNI_3CH_2CH_QS5
    edt, [8.13 kB]
    GP_UNI_BioRad
    prcl, [1.33 kB]
    RG_UNI_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_EV_Leaflet_EN
    pdf, [550.58 kB]

    Manual

    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]
    Mic qPCR Cycler_EN
    pdf, [2.33 MB]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 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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