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    GeneProof Treponema pallidum PCR Kit

    CE IVD
    GeneProof Treponema pallidum PCR Kit

    PRODUCT ADVANTAGES

     

    HIGHLY SPECIFIC DETECTION

    • Secured by highly conservative polA gene for DNA polymerase I

    UNIVERSAL PCR PROFILE

    • Simplifies laboratory workflow
    • Easily combinable with other PCR kits from the STI group, especially with GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit
    • Suitable for differential diagnostics of genital ulcer, appearing in the primary stage of syphilis

    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 Treponema pallidum PCR Kit TP/GP/025 real-time PCR 25 reactions
    GeneProof Treponema pallidum PCR Kit TP/GP/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_TP_QCMD_12_21_EN_02
    pdf, [146.76 kB]
    open
    GP_TP_QCMD_12_21_EN_01
    pdf, [145.88 kB]
    open
    GP_TP_Instand_06_21_EN
    pdf, [901.27 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 gene polA encoding DNA polymerase I
    Analytical Specificity Treponema pallidum, 100 %
    Analytical Sensitivity (LoD)

    reaches up to 0.61 cp/μl with the probability of 95 % (on synthetic DNA ultramer Control Treponema pallidum)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen swab from genital ulcer, urine, transport medium: UTM® Viral Transport* (COPAN Diagnostics Inc.)
    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
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    LightCycler ® 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    StepOne™ / StepOne Plus™ Real-Time PCR System
    Required Detection Channels FAM, HEX
    External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
    Certification CE IVD 

    * UTM® Viral Transport is validated only in combination with croBEE NA16 Nucleic Acid Extraction System
    ** Validated Instrument

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_TP_Instruction for Use_EN
    pdf, [277.84 kB]

    Declaration of Conformity

    GP_TP_Declaration of Conformity_EN
    pdf, [308.72 kB]

    MSDS

    GP_TP_Safety_Data_Sheet_EN
    pdf, [274.97 kB]

    PCR Template

    GP_DNA_3CH_2CH_ABI7500
    edt, [10.72 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]
    GP_Treponema pallidum_Mic
    micassay, [22 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_TP_Leaflet_EN
    pdf, [165.31 kB]

    Manual

    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]
    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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