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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

    CONTAMINATION ELIMINATION

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

    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

    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)

    reaches up to 0.745 IU/μl with the probability of 95 %
    (on 1st WHO International standard for Human Papillomavirus Type 16 DNA)
    reaches up to 1.561 IU/μl with the probability of 95 %
    (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 NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LightCycler® 480
    LineGene 9600 / 9600 Plus
    QuantStudio™ 3 Real-Time PCR System
    SLAN® Real-Time PCR System
    VERSANT® kPCR Molecular System
    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
    Certification CE IVD for in vitro Diagnostics Use

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.43 MB]
    GP_HPVS_Instruction for Use_EN
    pdf, [65.68 kB]

    Declaration of Conformity

    GP_HPVS_Declaration of Conformity_EN
    pdf, [315.31 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 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]

    Product Leaflet

    GP_HPVS_Leaflet_EN
    pdf, [148.05 kB]
    Files are available only for registered users.

    Order

    +420 543 211 679
    sales@geneproof.com

    Technical Support 

    Send request
    +420 730 176 222
    support@geneproof.com

    FAQ

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