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    GeneProof Gardnerella vaginalis PCR Kit

    CE IVD
    GeneProof Gardnerella vaginalis PCR Kit

    PRODUCT ADVANTAGES

     

    COMPLETE SOLUTION FOR STI

    • As a part of STI Panel enables a comprehensive solution for symptomatic STI diagnostics 
    • Suitable especial for differential diagnostics of non-candidal vulvovaginitis

    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

    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 Gardnerella vaginalis PCR Kit GV/GP/025 real-time PCR 25 reactions
    GeneProof Gardnerella vaginalis PCR Kit GV/GP/100 real-time PCR 100 reactions

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory status CE IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence

    tuf gene for transcription elongation factor
    Analytical Specificity

    Gardnerella vaginalis, 100 %
    Analytical Sensitivity (LoD)

    0,82 cp/µl (performed on AmpliRun® GVA DNA control, Vircell)
    Diagnostic Specificity 93.33 % (CI95%: 86.28 % - 97.05 %) 
    Diagnostic Sensitivity 100.00 % (CI95%: 91.73 % - 100.00 %) 
    Positive Predictive Value 88.52 % (CI95%: 77.17% - 94.88 %) 
    Negative Predictive Value 100.00 % (CI95%: 95.30 % - 100.00 %) 
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Control
    Validated Specimen swab, urine
    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 
    AMPLilab Real-Time PCR System
    AriaMx Real-Time PCR System 
    BioQuant-96 real-time PCR detection system
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System 
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 480
    Line Gene 9600 Plus
    Rotor-Gene 3000 / 6000 / Q
    Required Detection Channels

    FAM, HEX/JOE
    External Quality Assessment Regularly tested in 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, [1.55 MB]
    GP_GV_Instruction_for_Use_EN
    pdf, [284.18 kB]

    Declaration of Conformity

    GP_GV_Declaration_of_Conformity_EN
    pdf, [598.31 kB]

    MSDS

    GP_GV_Safety_Data_Sheet_EN
    pdf, [275.3 kB]

    Product Leaflet

    GP_GV_Leaflet_EN
    pdf, [122.61 kB]
    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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