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    GeneProof Adenovirus PCR Kit

    CE IVD
    GeneProof Adenovirus PCR Kit

    PRODUCT ADVANTAGES

     

    DETECTION OF ALL HUMAN ADENOVIRUS SPECIES

    • The kit enables detection of Adenovirus respiratory species A–D, G and gastrointestinal species E-F

    ASSURANCE BY NATIONAL REFERENCE LABORATORY

    • Clinical performance was provided by The National Institute of Public Health (National Reference Laboratory for Influenza)

    WIDE RANGE OF VALIDATED CLINICAL MATERIALS

    • Validated specimen: aspirate, plasma, stool, swab, urine, whole blood
    • Enables detection of both respiratory and gastrointestinal samples

    CONTAMINATION ELIMINATION

    • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible 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 Adenovirus PCR Kit ADV/ISEX/025 real-time PCR 25 reactions
    GeneProof Adenovirus PCR Kit ADV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_ADV_Instand_11_21_EN
    pdf, [114.79 kB]
    open
    ; GP_ADV_QCMD_06_22_EN
    pdf, [194.79 kB]
    open
    ; GP_Transplantation_QCMD_01_22_EN
    pdf, [200.17 kB]
    open
    ; GP_ADV_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 quantitative
    Target Sequence highly conservative DNA sequence of E2B gene
    Analytical Specificity

    Adenovirus, 100 %

    Analytical Sensitivity (LoD)

    reaches up to 81.41 cp/ml with the probability of 95 % (on AcroMetrixTM Adenovirus Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

    reaches up to 2371.645 cp/ml with the probability of 95 % (on Qnostics ADV Molecular ‚Q‘ Panel using manual
    extraction GeneProof PathogenFree DNA Isolation Kit)
    Diagnostic Specificity 87.98 % (CI95%: 82.16% – 92.15%)
    Diagnostic Sensitivity 100 % (CI95%: 91.11% – 100%)
    Linear Range

    1010 – 102.5 cp/ml with precision ± 0.5 log (using AcroMetrix™ Adenovirus Plasma Panel)
    1010 – 5x103 cp/ml with precision ± 0.5 log (using Qnostics ADV Molecular ‚Q‘ Panel)
    Dynamic Range 1010 – 81.41 cp/ml (using AcroMetrix™ Adenovirus Plasma Panel)
    1010 – 2371.645 cp/ml (using Qnostics ADV Molecular ‘Q‘ Panel)
    Reporting Units cp/μl
    Metrological Traceability

    Qnostics ADV Molecular ‚Q‘ Panel
    Extraction / Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen plasma, stool*, swab, urine, whole blood, aspirate
    * only in combination with QIAamp DNA stool Mini Kit
    Storage -20 ± 5 °C
    Validated Extraction Method

    croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    QIAamp DNA Stool Mini 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® 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 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 CE IVD

    * Validated instruments

    Documentation

    Instruction for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    ; GP_ADV_Advisory Notice_EN
    pdf, [910.39 kB]
    ; GP_ADV_Instruction for Use_EN
    pdf, [365.24 kB]
    ; GP_ADV_Instruction_for_Use_ES
    pdf, [164.82 kB]
    ; GP_ADV_Instruction_for_Use_FR
    pdf, [197.78 kB]
    ; GP_ADV_Instruction_for_Use_IT
    pdf, [196.25 kB]

    Declaration of Conformity

    ; GP_ADV_Declaration_of_Conformity_EN
    pdf, [610.34 kB]

    MSDS

    ; GP_ADV_Safety_Data_Sheet_EN
    pdf, [278.56 kB]

    Publications

    ; GP_IT_Publications_08_2022_EN
    pdf, [276.77 kB]
    ; GP_RESPIRATORY_Publications_10_2022_EN
    pdf, [142.69 kB]

    PCR Template

    ; GP_Adenovirus_Mic
    micassay, [13.85 kB]
    ; GP_DNA_3CH_2CH_AriaMx
    amxt, [3.61 kB]
    ; GP_DNA_3CH_2CH_croBEE
    fqt, [4.91 kB]
    ; GP_DNA_3CH_2CH_NOROX_ABI7500
    edt, [10.33 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_ADV_Leaflet_EN
    pdf, [143.61 kB]
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 kB]
    ; GP_Transplantation_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 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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    Customer Support 

    Send request
    +420 730 176 222
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    FAQ

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