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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_HPVS_Instand_07_22_EN
    pdf, [1.06 MB]
    open
    ; GP_HPVS_Instand_06_21_EN
    pdf, [1 MB]
    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 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)
    Sample Processing Channel Sensitivity Performed on
    Without extraction (plasmid) FAM 745 IU/ml NIBSC 06/202, HPV 16
    Without extraction (plasmid) Cy5 766 IU/ml NIBSC 06/202, HPV 16
    croBEE®max Nucleic Acid Extraction Kit FAM 4758 IU/ml NIBSC 06/202, HPV 16
    croBEE®max Nucleic Acid Extraction Kit Cy5 1558 IU/ml NIBSC 06/202, HPV 16
    Without extraction (plasmid) FAM 1561 IU/ml NIBSC 06/206, HPV 18
    Without extraction (plasmid) TexRed 2177 IU/ml NIBSC 06/206, HPV 18
    croBEE®max Nucleic Acid Extraction Kit FAM 4906 IU/ml NIBSC 06/206, HPV 18
    croBEE®max Nucleic Acid Extraction Kit TexRed 3262 IU/ml NIBSC 06/206, HPV 18
    Diagnostic Specificity 99 % (CI95%: 93.6 % – 99.9 %)
    Diagnostic Sensitivity 100% (CI95%: 87.7 % – 100 %)
    Extraction/Inhibition Control

    Proper sampling, DNA extraction efficiency and PCR inhibition control by endogenous Internal control (GAPDH gene)
    Validated Specimen Cervical, vaginal and penile swab (transport medium: LBC medium NOVAPREP (Novacyte); SurePath (BD) Self-sampling device FLOQSwab (COPAN); Evalyn® Brush (Rovers medical))
    Storage -20 ± 5 °C
    Validated Extraction Methods

    croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    croBEE®max Nucleic Acid Extraction Kit
    Instruments croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System(detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
    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
    Gentier 96E/96R Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
    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)
    Detection Channels FAM (HPV HR), HEX/JOE/VIC (IC), Cy5 (HPV 16), Texas Red/ROX (HPV 18), Cy5.5/Quasar 705 (HPV 45)
    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_HPVS_Advisory_Notice_05_22_EN
    pdf, [804.14 kB]
    ; GP_HPVS_Instruction_for_Use_EN
    pdf, [298.39 kB]
    ; GP_HPVS_Instruction_for_Use_ES
    pdf, [141.96 kB]
    ; GP_HPVS_Instruction_for_Use_FR
    pdf, [145.27 kB]

    Declaration of Conformity

    ; GP_HPVS_Declaration_of_Conformity_EN
    pdf, [544.98 kB]

    MSDS

    ; GP_HPVS_Safety_Data_Sheet_EN
    pdf, [274.3 kB]

    Product Leaflet

    ; GP_HPVS_Leaflet_EN
    pdf, [155.5 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 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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