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    GeneProof Chlamydia trachomatis PCR Kit

    CE 1023 IVD
    GeneProof Chlamydia trachomatis PCR Kit

    PRODUCT ADVANTAGES

     

    DUAL TARGET DETECTION

    • Dual target detection of the 16S rRNA gene and a cryptic plasmid

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of the 16S rRNA gene

    RELIABLE DETECTION OF SWEDISH VARIANT OF CHLAMYDIA TRACHOMATIS

    • Elimination of false-negative results caused by a sequence variation in the cryptic plasmid

    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 Chlamydia trachomatis PCR Kit CHT/ISEX/025 real-time PCR 25 reactions
    GeneProof Chlamydia trachomatis PCR Kit CHT/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_CHT_QCMD_09_21_EN_02
    pdf, [133.66 kB]
    open
    GP_CHT_QCMD_09_21_EN_01
    pdf, [134.65 kB]
    open
    GP_CTNG_QCMD_09_21_EN_02
    pdf, [139.59 kB]
    open
    GP_CTNG_QCMD_09_21_EN_01
    pdf, [138.43 kB]
    open
    GP_CHT_Instand_06_21_EN
    pdf, [901.17 kB]
    open
    GP_CHT_C2_QCMD_11_2020_EN
    pdf, [132.14 kB]
    open
    GP_CHT_C2_QCMD_11_2020_EN
    pdf, [129.73 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 the cryptic plasmid multi-copy sequence and the 16S rRNA gene for C. trachomatis
    Analytical Specificity Chlamydia trachomatis, including mutations with deletions in cryptic plasmid (including Swedish variant), 100 %
    Analytical Sensitivity (LoD) reaches up to 0.075 cp/μl with the probability of 95 % (on Amplirun® Chlamydia trachomatis DNA control, Vircell)
    Diagnostic Specificity 99.21  (CI95%: 99.07% - 99.34%)
    Diagnostic Sensitivity 100% (CI95%: 99.58% - 100%)
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control 
    Validated Specimen sperm, swab, urine
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    ccroBEE 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
    DTlite Real-Time PCR System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    QuantStudio™ 3 / 5 Real-Time PCR System
    StepOne™ 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

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_CHT_Advisory Notice_EN_CZ
    pdf, [271.73 kB]
    GP_CHT_Advisory_Notice_05_22_EN
    pdf, [450.59 kB]
    GP_CHT_Instruction for Use_EN
    pdf, [136.51 kB]

    Declaration of Conformity

    GP_CHT_Declaration of Conformity_EN
    pdf, [318.47 kB]
    GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]

    MSDS

    GP_CHT_Safety_Data_Sheet_EN
    pdf, [275.03 kB]

    Publications

    STI_publications
    pdf, [254.48 kB]

    PCR Template

    GP_Chlamydia trachomatis_Mic
    micassay, [21.95 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_CHT_Leaflet_EN
    pdf, [135.85 kB]
    GP_Poster_EN
    pdf, [100.68 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.

    Gallery

    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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