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    GeneProof Hepatitis C Virus (HCV) PCR Kit

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

    PRODUCT ADVANTAGES

     

    DETECTS A BROAD SPECTRUM OF HCV GENOTYPES

    • The kit detects HCV genotypes 1 – 7

    SINGLE TUBE READY-TO-USE MASTERMIX

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

    INTERNAL RNA CONTROL

    • Controls the whole diagnostic process
    • RNA extraction, reverse transcription and PCR amplification
    • IC is included in the PCR Kit

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

     

    Product on request. For more information contact your sales manager or sales@geneproof.com.

    Order information

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

    EQA Panels

    EQA results

    GP_HCVD_QCMD_2020
    pdf, [192.74 kB]
    open
    GP_HCV_QCMD_EN
    pdf, [167.06 kB]
    open
    GP_Instand_03.2019_EN
    pdf, [327.24 kB]
    open
    Choose all

    Technical specification

    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)

    Reaches up to 7.87 IU/ml with the probability of 95% (on AcroMetrix
    HCV High Control using automatic extraction MagCore NA Extractor)
    Reaches up to 208.54 IU/ml with the probability of 95% (on AcroMetrix
    HCV High Control using automatic extraction croBEE NA16 Nucleic Acid
    Extraction System)
    Reaches up to 213.965 IU/ml with the probability of 95% (on HCV NIBSC
    14/150 using manual extraction GeneProof PathogenFree RNA Isolation
    Kit)
       
     Linear Range  1010 - 25 IU/ml with precision of ± 0.5 log
    Dynamic Range  1010 - 7.87 IU/ml
    Reporting Units
    IU/μl (1 IU = 5.62 cp)
    Validated Specimen Plasma, serum
    Storage -20 ± 5 °C  
    Validated Extraction Methods

    croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree RNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System*
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    DT lite Real-Time PCR System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX
    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 for in vitro Diagnostic Use 

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.49 MB]
    GP_HCV_Instruction for Use_EN
    pdf, [367.94 kB]

    Declaration of Conformity

    GP_FQAS EC Certificate_EN
    pdf, [48.26 kB]
    GP_HCV_Declaration of Conformity_EN
    pdf, [298 kB]

    MSDS

    GP_HCV_PCR_Kit_Safety Data Sheet_PCR Kit_EN
    pdf, [140.74 kB]

    Manual

    croBEE Real-Time PCR System_EN
    pdf, [5.9 MB]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]

    PCR Template

    GP_HCV_Mic
    micassay, [13.09 kB]
    Files are available only for registered users.

    Gallery

    Order

    +420 543 211 679
    sales@geneproof.com

    Technical Support 

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

    FAQ

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