Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching
    • /
    • search

    GeneProof Neisseria gonorrhoeae PCR Kit

    CE IVD
    GeneProof Neisseria gonorrhoeae PCR Kit

    PRODUCT ADVANTAGES

     

    DUAL TARGET DETECTION

    • Dual target detection of the 16S rRNA gene and the porA pseudogene

    HIGH SENSITIVITY

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

    RELIABLE DETECTION OF porA MUTANT

    • Elimination of false-negative results caused by a sequence variation in the porA pseudogene

    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 Neisseria gonorrhoeae PCR Kit NG/ISEX/025 real-time PCR 25 reactions
    GeneProof Neisseria gonorrhoeae PCR Kit NG/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_NG_QCMD_05_22_EN_02
    pdf, [123.02 kB]
    open
    ; GP_NG_QCMD_05_22_EN_01
    pdf, [121.91 kB]
    open
    ; GP_NG_QCMD_09_21_EN_02
    pdf, [120.21 kB]
    open
    ; GP_NG_QCMD_09_21_EN_01
    pdf, [121.38 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_NG_Instand_06_21_EN
    pdf, [901.17 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
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence

    A multi-copy sequence of the gene encoding 16S rRNA and porA preudogene specific for N. gonorrhoeae
    Analytical Specificity

    N. gonorhoeae, including mutants in porA pseudogene, 100 % 
    Analytical Sensitivity (LoD with 95% probability)

     0.109 cp/µl (on Amplirun® Neisseria gonorrhoeae DNA control, Vircell)
    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
    AriaMx Real-Time PCR System
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOneTM / StepOnePlusTM Real-Time PCR System
    QuantStudio™ 3 / 5 Real-Time PCR System
    Required Detection Channels FAM, HEX
    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, [1.6 MB]
    ; GP_NG_Instruction for Use_EN
    pdf, [548.89 kB]

    Declaration of Conformity

    ; GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]
    ; GP_NG_Declaration_of_Conformity_EN
    pdf, [576.54 kB]

    MSDS

    ; GP_NG_Safety_Data_Sheet_EN
    pdf, [275.52 kB]

    Publications

    ; STI_publications
    pdf, [254.48 kB]

    PCR Template

    ; 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]
    ; GP_Neisseria gonorrhoeae_Mic
    micassay, [21.95 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    ; GP_NG_Leaflet_EN
    pdf, [173.19 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.

    Order

    +420 543 211 679
    [obfuscate_1_|114|88|106|94|112|63|94|99|103|98|111|105|109|104|99|45|90|109|102]

    Technical Support 

    Send request
    +420 730 176 222
    [obfuscate_1_|114|108|110|105|108|113|107|62|96|98|109|92|110|107|108|110|93|44|92|108|108]

    FAQ

    News

    The biggest myths about IVDR

    Do you know the biggest myths that are connected with the new IVD Regulation?

    IVDR products available!

    All our Class „A“ products are now IVDR certified as required since May, 2022. Let’s see our offer!

    more