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    GeneProof Human Papilloma Virus (HPV) Screening PCR Kit

    CE IVD
    GeneProof Human Papilloma Virus (HPV) Screening PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SPECIFICITY

    • Unique detection of 24 high-risk HPV types

    SELF-SAMPLING OPTION

    • Validation of self-sampling devices Evalyn® Brush (Rovers Medical Devices) and FLOQSwab® (COPAN)
    • Supports wide-spreading of HPV screening through simple and comfortable sampling
    • Housekeeping GAPDH for correct sampling control

    CONTAMINATION PREVENTION

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

    DIFFERENTIATION OF HIGH-RISK TYPES 16, 18 AND 45

    • HPV16 and HPV18 are responsible for 70% of cervical cancer cases and pre-cancerous cervical lesion
    • HPV45 is the 3rd most prevalent genotype in cases of invasive cervical cancer worldwide (5–6%)
    • Enables specific management of patient monitoring and therapy

    COMPLIANCE WITH GUIDELINES FOR HPV SCREENING

    • German S3-guidelines “Prevention of cervical cancer” (S3-Leitlinie Prävention des Zervixkarzinoms Langverison 1.0 – Dezember 2017)
    • The clinical and reproducibility criteria of the International Guidelines for HPV tests for use in cervical cancer screening

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Human Papilloma Virus (HPV) Screening PCR Kit HPVS/GP/025 real-time PCR 25 reactions
    GeneProof Human Papilloma Virus (HPV) Screening PCR Kit HPVS/GP/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_HPV_Instand_06_20_EN
    pdf, [894.5 kB]
    open
    GP_HPV_Instand_06_21_EN
    pdf, [1 MB]
    open
    Choose all

    Technical specification

    Technology real-time PCR
    Type of Analysis qualitative
    Target sequence E1/E2 gene
    Analytical Specificity Human Papillomavirus high-risk types 16, 18, 26, 30, 31, 33, 34, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69,
    70, 73, 82, 97 with differentiation of 16, 18 and 45 types

    Analytical Sensitivity

    (LoD with 95% probability)

    		 0.745 IU/µl (on 1st WHO International standard for Human Papillomavirus Type 16 DNA)
    1.561 IU/µl (on 1st WHO International standard for Human Papillomavirus Type 18 DNA)
    Diagnostic Specificity 99 % (CI95%: 93.6 % – 99.9 %)
    Diagnostic Sensitivity 100% (CI95%: 87.7 % – 100 %)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen Swab (cervical, vaginal and penile), LBC medium NOVAPREP (Novacyte), SurePath (BD),
    Self-sampling device FLOQSwab® (COPAN), Evalyn® Brush (Rovers Medical Devices)
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Instruments croBEE Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
    AriaMx Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
    CFX Connect™ Real-Time PCR Detection System (detection of high-risk HPV without differentiation)
    CFX96™/Dx Real-Time PCR Detection System
    LightCycler® 480 (detection of high-risk HPV without differentiation)
    LineGene 9600 Plus
    QuantStudio™ 3 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 18)
    QuantStudio™ 5 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
    Rotor-Gene Q (detection of high-risk HPV and presence HPV18, 16, and 45 but it does not distinguish coinfection of types 16, 18 and 45 respect
    to the crosstalk between the channels TexRed/Cy5 and Cy5/Cy5.5)
    SLAN® Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16)
    Stratagene Mx3005p qPCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
    Required Detection Channels FAM, HEX, Cy5, Texas Red, Cy5.5
    External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
    Regulatory Status CE IVD 

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.49 MB]
    GP_HPVS_Instruction for Use_EN
    pdf, [65.68 kB]
    GP_HPVS_Instruction_for_Use_FR
    pdf, [241.91 kB]

    Declaration of Conformity

    GP_HPVS_Declaration of Conformity_EN
    pdf, [315.31 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 kB]

    Product Leaflet

    GP_Leaflet_A4_HPVscreening-EN_2021
    pdf, [219.15 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]
    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]
    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]
    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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