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    GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

    CE 1023 IVD
    GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit

    PRODUCT ADVANTAGES

     

    UNIQUE DUAL TARGET DETECTION 

    • Prevents analysis failure caused by the appearance of mutants
    • Ensures maximum sensitivity, reaches up to 7.95 IU/ml
    • Ensures maximum specificity

    CONTAMINATION ELIMINATION

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

    INTERNAL RNA CONTROL

    • Controls the whole diagnostic process, i.e. efficiency of RNA extraction, reverse transcription and PCR amplification
    • IC is included in the PCR kit

    DETECTS THE NEWLY DESCRIBED GENOTYPES 7 AND 8

    • The kit detects all known HCV genotypes 1–8

    SINGLE TUBE READY-TO-USE MASTER MIX

    • Contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary
    • Reduces the need for qualified laboratory staff
    • Ensures reproducibility of the results

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/025 real-time PCR 25 reactions
    GeneProof Hepatitis C Virus (HCV) Diagnostic PCR Kit HCVD/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_HCVD_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    GP_HCVD_QCMD_2020
    pdf, [192.74 kB]
    open
    GP_HCVD_QCMD_manual_2019_EN
    pdf, [167.03 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Target Analysis Qualitative and Quantitative 
    Target Sequence conservative region of 5' UTR sequence
    Analytical Specificity HCV genotype 1–8, 100 %
    Analytical Sensitivity (LoD)

    53.505 IU/ml (on HCV NIBSC 14/150 using GeneProof PathogenFree RNA Isolation Kit)
    170.062 IU/ml (on HCV NIBSC 14/150 using croBEE 201A Nucleic Acid Extraction Kit)
    33.473 IU/ml (on Acrometrix HCV-S Panel using MagCore Automated NA Extractor)
    7.95 IU/ml (on Acrometrix HCV-S Panel using SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution)
    Diagnostic Specificity  

    100 % (CI95 % : 99.07 % - 100 %)
    Diagnostic Sensitivity 100 % (CI95 % : 95.39 % - 100 %)
    Linear Range  108.5 – 102 IU/ml with precision of ± 0.5 log (GeneProof PathogenFree RNA Isolation Kit)
    108.5 – 170.062 IU/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction System)
    108.5 – 101.7 IU/ml with precision of ± 0.5 log (MagCore Automated NA Extractor)
    Dynamic Range  108.5 – 53.505 IU/ml (GeneProof PathogenFree RNA Isolation Kit)
    108.5 – 170.062 IU/ml (croBEE 201A Nucleic Acid Extraction System)
    108.5 – 33.473 IU/ml (MagCore Automated NA Extractor)
    Reporting Units IU/μl
    Metrological Traceability HCV NIBSC 14/150
    Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEX version)
    Validated Specimen plasma (EDTA, citrate), serum
    Storage -20 ± 5 °C  
    Validated Extraction Methods

    croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree RNA Isolation Kit
    MagCore Automated NA Extractor
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AMPLilab Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    LightCycler® 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / 6000 / Q
    Required Detection Channels FAM, HEX
    Quality Control quality management system is certified in compliance with the requirements of the standard ISO 13485
    External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels - results available at www.geneproof.com  
    Regulatory Status CE1023 IVD 

     

     

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_HCVD_Advisory_Notice_05_22_EN
    pdf, [550.66 kB]
    GP_HCVD_Instruction_for_Use_EN
    pdf, [231.23 kB]
    GP_HCVD_Instruction_for_Use_ES
    pdf, [207.9 kB]
    GP_HCVD_Instruction_for_Use_FR
    pdf, [242.68 kB]

    Declaration of Conformity

    GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]
    GP_HCVD_Declaration of conformity_EN
    pdf, [339.96 kB]
    GP_HCVD_EC Design Examination Certificate_EN
    pdf, [336.18 kB]

    MSDS

    GP_HCVD_Safety_Data_Sheet_EN
    pdf, [278.39 kB]

    PCR Template

    GP_HCVD_Mic
    micassay, [13.09 kB]
    GP_HCVD_template_AmpliLAB
    tlpi, [3.04 kB]
    GP_UNI_3CH_2CH_ABI7500
    edt, [10.33 kB]
    GP_UNI_3CH_2CH_AriaMx
    amxt, [3.64 kB]
    GP_UNI_3CH_2CH_CroBee
    fqt, [4.9 kB]
    GP_UNI_BioRad
    prcl, [1.33 kB]
    RG_UNI_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_HCVD_Leaflet_EN
    pdf, [185.8 kB]

    Manual

    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]
    Mic qPCR Cycler_EN
    pdf, [2.33 MB]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    Files are available only for registered users.

    Gallery

    zvětšit
    HCV-shutterstock-525545404.jpg
    zvětšit
    RG_UNI_2CH_3CH_4CH

    Order

    +420 543 211 679
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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

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