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    GeneProof Trichomonas vaginalis PCR Kit

    CE IVD
    GeneProof Trichomonas vaginalis PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SPECIFICITY

    • Secured by a multicopy sequence of the beta-tubulin gene
    • Ensures excellent sensitivity reaches up to 0.25 cp/μl

    RELIABLE DETECTION 

    • Simple sensitive detection compared to wet mount microscopy and culture

    EASY-TO-USE CONCEPT

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

    CONTAMINATION PREVENTION

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

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one 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 Trichomonas vaginalis PCR Kit TV/GP/025 real-time PCR 25 reactions
    GeneProof Trichomonas vaginalis PCR Kit TV/GP/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_STI_Panel_Leaflet_EN
    pdf, [1.42 MB]
    open
    ; GP_TV_Leaflet_EN
    pdf, [129.38 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_STI I_QCMD_11_2022_EN
    pdf, [261.07 kB]
    open
    ; GP_TV_QCMD_09_21_EN_02
    pdf, [159.97 kB]
    open
    ; GP_TV_QCMD_09_21_EN_01
    pdf, [160.79 kB]
    open
    ; GP_TV_Instand_06_21_EN
    pdf, [901.27 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD
    Intended User For professional use in laboratories with trained staff
    Test Principle Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection
    Type of Analysis Qualitative
    Target Sequence Beta-tubulin gene
    Analytical Specificity Trichomonas vaginalis (TV), 100 %
    Analytical Sensitivity
    (LoD with 95% probability)

    0,25 cp/μl (on AmpliRun® Trichomonas vaginalis DNA control, Vircell)
    Diagnostic Specificity 98,21 % (CI95%: 89.19 % - 99,91 %)
    Diagnostic Sensitivity 100,00 % (CI95%: 87.68 % - 100,00 %)
    Positive Predictive Value 97,22 % (CI95%: 83.80 % - 99,85 %)
    Negative Predictive Value 100,00 % (CI95%: 91.87 % - 100,00 %)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Control (IC)
    Validated Specimen Swab (transport medium: UTM® Viral Transport, eNATTM, both from COPAN Diagnostics Inc.), urine
    Storage Conditions -20 ± 5 °C
    Validated Extraction Methods

    croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Applied Instruments croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    LightCycler ® 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    QuantStudioTM 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOne™ / StepOne Plus™ Real-Time PCR System
    Detection Channels FAM (TV), HEX/JOE/VIC (IC)
    External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

     

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_TV_Advisory_Notice_EN
    pdf, [874.56 kB]
    ; GP_TV_Instruction for Use_EN
    pdf, [289.37 kB]
    ; GP_TV_Instruction_for_Use_FR
    pdf, [106.95 kB]
    ; GP_TV_Instruction_for_Use_IT
    pdf, [145.69 kB]

    Declaration of Conformity

    ; GP_TV_Declaration of Conformity_EN
    pdf, [311.8 kB]

    MSDS

    ; GP_TV_Safety_Data_Sheet_EN
    pdf, [274.81 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_Trichomonas vaginalis_Mic
    micassay, [21.94 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Manual

    ; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
    pdf, [1.43 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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    Customer Support 

    Send request
    +420 730 176 222
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