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    GeneProof Chlamydia pneumoniae PCR Kit

    CE 1023 IVD
    GeneProof Chlamydia pneumoniae PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • Secured by targeting the ompA gene

    DIAGNOSTICS OF ATYPICAL PNEUMONIAE

    • Differential diagnostics of atypical bacterial respiratory pathogens
    • Easily combinable with GeneProof Mycoplasma pneumoniae PCR Kit and GeneProof Legionella pneumophila PCR kit

    EASY-TO-USE CONCEPT

    • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary
    • Simplifies laboratory workflow

    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

    CE1023IVD 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
    Regulatory Status CE1023IVD
    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) 0.647 cp/µl with the probability of 95 % (on Amplirun® Chlamydia pneumoniae DNA control, Vircell)
    Diagnostic Specificity 100% (CI95%: 95.01% - 100.00%)
    Diagnostic Sensitivity 99.08% (CI95%: 94.26% - 99.95%)
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
    Validated Specimen BAL, sputum, swab
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
    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
    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
    BioQuant-96 Real-Time PCR System
    Detection Channels FAM, HEX
    External Quality Control regularly tested by QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

    Documentation

    Instruction for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.6 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, [201.26 kB]
    ; GP_CHP_Instruction_for_Use_ES
    pdf, [221.06 kB]
    ; GP_CHP_Instruction_for_Use_FR
    pdf, [241.47 kB]

    Declaration of Conformity

    ; GP_CHP_Declaration_of_Conformity_EN
    pdf, [585.93 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, [138.12 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
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    Technical Support 

    Send request
    +420 730 176 222
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