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    GeneProof Aspergillus PCR Kit

    CE IVD
    GeneProof Aspergillus PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of the Intergenic spacer ITS2/28S rDNA

    DIFFERENTIATION OF ASPERGILLUS TERREUS

    • Enables specific antifungal therapy of resistant aspergillosis

    CONTAMINATION ELIMINATION

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

    HIGH SPECIFICITY

    • Detection of a wide range of Aspergillus species
    • Aspergillus fumigatus, Aspergillus flavus, Aspergillus niger, Aspergillus clavatus, Aspergillus nidulans, Aspergillus oryzae, Aspergillus ustus, Aspergillus versicolor, Aspergillus niveus, Aspergillus candidus, Aspergillus wentii, Aspergillus foetidus with differentiation of Aspergillus terreus

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

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

    EQA Panels

    EQA results

    GP_ASP_QCMD_12_20_EN_02
    pdf, [153.48 kB]
    open
    GP_ASP_QCMD_12_20_EN_01
    pdf, [151.85 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD / EC Directive 98/79/EC
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence ITS2/28S rDNA region
    Analytical Specificity

    Aspergillus spp. (A. fumigatus, A. flavus, A. niger, A. oryzae, A. candidus, A. foetidus, A. nidulans, A. ustus, A. versicolor, A. wentii, A. clavatus, A. niveus) (ASPspp), 100 %

    Aspergillus terreus (ASPT), 100 %

    Analytical Sensitivity (LoD with 95% probability)

    40.76 cp/ml, performed on AmpliRun® Aspergillus fumigatus DNA control (Vircell)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)
    Validated Specimen Whole blood, plasma, serum, BAL, sputum, CSF
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Validated Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System
    Aria Mx Real-Time PCR System
    CFX96™/ Dx Real-Time PCR Detection System
    LightCycler® 480
    LineGene 9600/9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 5 Real-Time PCR System
    Rotor-Gene 3000/Q
    AMPLilab RT PCR System
    Bio Quant-96
    Gentier 96E/96R Real-Time PCR System
    SLAN® Real-Time PCR System
    Required Detection Channels FAM (ASPspp), Cy5 (ASPT), HEX/JOE/VIC (IS)
    External Quality Assessment regularly tested by QCMD External Quality Assessment panels – results at www.geneproof.com

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_ASP_Advisory_Notice_02_22_EN_CZ
    pdf, [664.96 kB]
    GP_ASP_Advisory_Notice_05_22_EN
    pdf, [556.78 kB]
    GP_ASP_Instruction_for_Use_EN
    pdf, [294.08 kB]

    Declaration of Conformity

    GP_ASP_Declaration of Conformity_EN
    pdf, [567.7 kB]

    MSDS

    GP_ASP_Safety_Data_Sheet_EN
    pdf, [275.21 kB]

    PCR Template

    GP_Aspergillus_Mic
    micassay, [26.54 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_ASP_Leaflet_EN
    pdf, [217.28 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 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]
    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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