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    GeneProof Chlamydia pneumoniae PCR Kit

    CE 1023 IVD
    GeneProof Chlamydia pneumoniae PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • The best analytical sensitivity secured by targeting the ompA gene

    CONTAMINATION ELIMINATION

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

    UNIVERSAL PCR PROFILE

    • Enables rapid and sensitive detection of disease-causing agents of atypical pneumoniae
    • Beneficial in combination with GeneProof Mycoplasma pneumoniae PCR Kit and GeneProof Bordetella pertussis/parapertussis PCR Kit
    • 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 Chlamydia pneumoniae PCR Kit CHP/ISEX/025 real-time PCR 25 reactions
    GeneProof Chlamydia pneumoniae PCR Kit CHP/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_CHP_QCMD_07_21_EN_02
    pdf, [148.7 kB]
    open
    GP_CHP_QCMD_07_21_EN_01
    pdf, [148.27 kB]
    open
    GP_CHP_Instand_06_2021_EN
    pdf, [901.22 kB]
    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
    Target Sequence specific conservative DNA sequence of a single-copy ompA gene
    Analytical Specificity C. pneumoniae, 100 %
    Analytical Sensitivity (LoD) reaches up to 0.647 cp/μl with the probability of 95%
    Diagnostic Specificity 100% (CI95%: 97.50% - 100.00%)
    Diagnostic Sensitivity 98.81% (CI95%: 92.62% - 99.94%)
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
    Validated Specimen BAL, sputum, swab
    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 Control regularly tested by QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com
    Certification CE1023 IVD for in vitro Diagnostic Use

    *Validated instruments

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_CHP_Advisory Notice_EN_CZ
    pdf, [273.24 kB]
    GP_CHP_Advisory_Notice_05_22_EN
    pdf, [508.72 kB]
    GP_CHP_Instruction for Use_EN
    pdf, [132.85 kB]

    Declaration of Conformity

    GP_CHP_Declaration of Conformity_EN
    pdf, [315 kB]
    GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]

    MSDS

    GP_CHP_Safety_Data_Sheet_EN
    pdf, [275.22 kB]

    PCR Template

    GP_Chlamydia pneumoniae_Mic
    micassay, [21.96 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_CHP_Leaflet_EN
    pdf, [144.59 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, [1.8 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
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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

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