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    GP Letak A4 HBV IVDD EN 5 2023

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    Fatima Vessalius
    The GeneProof Hepatitis B Virus (HBV) PCR Kit is an in vitro diagnostic medical device for detecting HBV. The kit uses real-time PCR to target the P gene with high specificity and sensitivity down to 13.9 IU/ml. It is compatible with many real-time PCR devices and provides quantitative results traceable to the WHO standard.

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    GP Letak A4 HBV IVDD EN 5 2023

    Uploaded by

    Fatima Vessalius
    30 views2 pages
    The GeneProof Hepatitis B Virus (HBV) PCR Kit is an in vitro diagnostic medical device for detecting HBV. The kit uses real-time PCR to target the P gene with high specificity and sensitivity down to 13.9 IU/ml. It is compatible with many real-time PCR devices and provides quantitative results traceable to the WHO standard.

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    12393-GP-Letak-A4-HBV-IVDD-EN-5-2023

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    The GeneProof Hepatitis B Virus (HBV) PCR Kit is an in vitro diagnostic medical device for detecting HBV. The kit uses real-time PCR to target the P gene with high specificity and sensitivity down to 13.9 IU/ml. It is compatible with many real-time PCR devices and provides quantitative results traceable to the WHO standard.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    30 views2 pages

    GP Letak A4 HBV IVDD EN 5 2023

    Uploaded by

    Fatima Vessalius
    The GeneProof Hepatitis B Virus (HBV) PCR Kit is an in vitro diagnostic medical device for detecting HBV. The kit uses real-time PCR to target the P gene with high specificity and sensitivity down to 13.9 IU/ml. It is compatible with many real-time PCR devices and provides quantitative results traceable to the WHO standard.

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    © All Rights Reserved
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    Bloodborne

    Infections
    GeneProof Hepatitis B Virus
    (HBV) PCR Kit

    HIGH SPECIFICITY W.H.O. STANDARD BASED


    • Secured by targeting specific conservative
    QUANTIFICATION
    DNA sequence of P gene • Precise and fully traceable quantification
    • Prevents detection failure caused by the according to 4th WHO International Standard
    occurrence of mutations (including safe NIBSC 10/266
    detection of core and pre-core mutants)
    • Detection of all HBV genotypes A – H
    • 100% diagnostic specificity
    CONTAMINATION PREVENTION
    • Master Mix contains Uracil-DNA glycosylase
    (UNG) and dUTPs eliminating carryover
    HIGH SENSITIVITY contamination
    • Ensures excellent sensitivity up to 13.9 IU/ml
    • 100% diagnostic sensitivity
    ORDER INFORMATION

    EASY-TO-USE CONCEPT REF PACKAGE

    HBV/ISEX/025 25 reactions
    • Single tube Ready-to-Use Master Mix contains
    HBV/ISEX/100 100 reactions
    all components for PCR amplification
    • No additional PCR reagents pipetting necessary

    COMPATIBLE WITH A WIDE


    CERTIFIED
    RANGE OF REAL-TIME PCR
    DIAGNOSTIC TEST
    DEVICES

    GUARANTEED CONTROL OVER THE COMPLETE PROCESS


    www.geneproof.com OF DEVELOPMENT, MANUFACTURING AND DISTRIBUTION
    OF ALL THE OFFERED GENEPROOF PRODUCTS
    GeneProof Hepatitis B Virus (HBV) PCR Kit
    Bloodborne
    Infections

    + GeneProof Hepatitis C Virus + GeneProof HIV type 1 (HIV-1) + GeneProof HIV type 1 (HIV-1)
    (HCV) Diagnostic PCR Kit Diagnostic PCR Kit PCR Kit
    + GeneProof Hepatitis B Virus
    (HBV) PCR Kit

    INDICATION in vitro diagnostic medical device

    REGULATORY STATUS CE1023 IVD

    INTENDED USER For professional use in laboratories with trained staff

    TECHNOLOGY Real-time PCR

    TYPE OF ANALYSIS Qualitative and quantitative

    TARGET SEQUENCE specific conservative DNA sequence of P gene

    ANALYTICAL SPECIFICITY HBV genotype A-H, precore mutants HBV (HBeAg negative), 100 %

    ANALYTICAL SENSITIVITY 36.9792 IU/ml (on HBV NIBSC 05/148 using GeneProof PathogenFree DNA Isolation Kit),
    (LoD with probability 95 %) 64.067 IU/ml (on HBV NIBSC 10/266 using croBEE 201A Nucleic Acid Extraction Kit),
    13.9 IU/ml (on HBV NIBSC 10/266 using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar
    Pretreatment Solution)
    DIAGNOSTIC SPECIFICITY 100.00 % (CI95%: 99.06 % – 100.00 %)

    DIAGNOSTIC SENSITIVITY 100.00 % (CI95%: 95.90 % – 100.00 %)

    LINEAR RANGE 1010 – 102 IU/ml with precision of ± 0.5 log

    DYNAMIC RANGE 1010 – 36.9792 IU/ml (using GeneProof PathogenFree DNA Isolation Kit)
    1010 – 64.067 IU/ml (using croBEE 201A Nucleic Acid Extraction Kit)
    REPORTING UNITS IU/ml

    METROLOGICAL TRACEABILITY HBV NIBSC 10/266 (4th WHO International Standard)

    VALIDATED SPECIMEN Plasma, serum

    STORAGE -20 ± 5 °C

    VALIDATED EXTRACTION METHOD croBEE 201A Nucleic Acid Extraction Kit


    GeneProof PathogenFree DNA Isolation Kit
    INSTRUMENTS croBEE Real-Time PCR System Gentier 96E/96R Real-Time PCR System
    AMPLilab Real-Time PCR System LightCycler® 2.0 / 480
    Applied Biosystems 7300 / 7500 Real-Time PCR LineGene 9600 / 9600 Plus
    System Mic qPCR Cycler
    AriaMx Real-Time PCR System QuantStudioTM 3 / 5 Real-Time PCR System
    BioQuant-96 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q
    CFX Connect™ / CFX96™/ Dx Real-Time PCR SLAN® Real-Time PCR System
    Detection System StepOneTM/StepOne PlusTM Real-Time PCR System
    DT lite 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
    GeneProof a.s. / 08-2022

    GeneProof a.s.
    www.geneproof.com Vídeňská 101/119 / Dolní Heršpice / 619 00 Brno / Czech Republic
    +420 543 211 679 PHONE / info@geneproof.com E-MAIL

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