Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching
    • /
    • search

    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 [obfuscate_1_|114|89|99|94|115|63|95|92|103|101|111|106|102|104|102|45|91|102|102].

    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_HCVplus_QCMD_2020_EN
    pdf, [192.63 kB]
    open
    GP_HCV_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    GP_HCV_Instand_04_20_EN
    pdf, [909.63 kB]
    open
    GP_HCV_QCMD_EN
    pdf, [167.06 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)

    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]

    PCR Template

    GP_HCV_Mic
    micassay, [13.09 kB]

    Manual

    croBEE Real-Time PCR System_EN
    pdf, [5.9 MB]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    Files are available only for registered users.

    Gallery

    Order

    +420 543 211 679
    [obfuscate_1_|114|89|99|94|115|63|95|92|103|101|111|106|102|104|102|45|91|102|102]

    Technical Support 

    Send request
    +420 730 176 222
    [obfuscate_1_|114|109|103|105|111|113|108|55|96|101|109|93|103|107|111|110|94|37|92|111|108]

    FAQ

    News

    GeneProof detect OMICRON variant

    A new variant of the SARS-CoV-2 virus, known among others as OMICRON, is spreading around the world.…

    Let's meet at MEDICA 2021 in Düsseldorf

    Meet us at MEDICA 2021 World Forum for Medicine!

    more