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    GeneProof Chlamydia trachomatis PCR Kit

    CE 1023 IVD
    GeneProof Chlamydia trachomatis PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SENSITIVITY

    • Secured by targeting the multicopy sequence of the 16S rRNA gene
    • Dual target detection of the 16S rRNA gene and a cryptic plasmid

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other PCR kits from the STI Panel in one workflow

    EASY-TO-USE CONCEPT

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

    RELIABLE DETECTION OF SWEDISH VARIANT OF CHLAMYDIA TRACHOMATIS

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

    CONTAMINATION PREVENTION

    • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

     

    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_05_22_EN_02
    pdf, [127.76 kB]
    open
    ; GP_CHT_QCMD_05_22_EN_01
    pdf, [126.74 kB]
    open
    ; 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
    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 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) 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 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AMPLilab
    AriaMx Real-Time PCR System
    BioQuant-96
    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
    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

    Documentation

    Instruction for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.6 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, [211.72 kB]
    ; GP_CHT_Instruction_for_Use_ES
    pdf, [214.83 kB]
    ; GP_CHT_Instruction_for_Use_FR
    pdf, [255.3 kB]

    Declaration of Conformity

    ; GP_CHT_Declaration_of_Conformity_EN
    pdf, [618.97 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, [121.03 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]
    ; 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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