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    GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

    CE IVD
    GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION WITH LESS SAMPLES

    • Detects and distinguishes Herpes Simplex Virus 1 and Herpes Simplex Virus 2 in a single reaction tube


    UNIVERSAL PCR PROFILE

    • Easily combinable with other PCR kits from the Immunocompromised / Transplanted, Neuroinfections and Sexually TransmittedInfections groups
    • Simplifies laboratory workflow


    EXCELLENT EQA PANEL RESULTS

    • The highest possible diagnostic sensitivity (100.00 %) and diagnostic specificity (99.25 %) confirmed by analysis of EQA panel reports from 2009 to present (including infrequently detected rare samples with very low concentrations)


    CONTAMINATION ELIMINATION

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

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISEX/025 real-time PCR 25 reactions
    GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_ HSV_QCMD_2020_EN
    pdf, [135.27 kB]
    open
    GP_HSV_QCMD_2018_EN
    pdf, [171.34 kB]
    open
    GP_HSV_QCMD_C2.2018_EN
    pdf, [164.59 kB]
    open
    GP_HSV_QCMD_C2.2019_EN
    pdf, [164.59 kB]
    open
    GP_HSV_QCMD_croBEE_2019_EN
    pdf, [145.3 kB]
    open
    GP_HSV_QCMD_manual_2019_EN
    pdf, [145.41 kB]
    open
    GP_Instand_06.2018_EN
    pdf, [1.36 MB]
    open
    GP_Instand_06.2019_EN
    pdf, [340.8 kB]
    open
    Choose all

    Technical specification

    Technology real-time PCR
    Type of Analysis qualitative and quantitative
    Target Sequence specific conservative DNA sequence of a single-copy gene encoding glycoprotein B (gB)
    Analytical Specificity

    Herpes simplex virus type 1 (HSV-1), 100 %
    Herpes simplex virus type 2 (HSV-2), 100 %
    Analytical Sensitivity (LoD)

    for HSV-1 reaches up to 122.124 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-1 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    for HSV-2 reaches up to 194.49 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-2 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)
    Diagnostic Specificity 99.24 % (CI95%: 95.23 % – 99.96 %)
    Diagnostic Sensitivity 100 % (CI95%: 97.08 % – 100 %)
    Linear Range 

    for HSV-1: 1010 - 102.5 cp/ml with precision of ± 0.5 log
    for HSV-2: 1010 - 102.5 cp/ml with precision of ± 0.5 log
    Reporting Units

    cp/μl
    Metrological Traceability

    AcroMetrixTM HSV-1 Plasma Panel (AcroMetrix HSV-1)
    AcroMetrixTM HSV-2 Plasma Panel (AcroMetrix HSV-2)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control
    Validated Specimen whole blood, plasma, urine, CSF
    Storage -20 ± 5 °C
    Validated Extraction Method

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

    croBEE Real-Time PCR System*
    Applied Biosystems 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX96™ / Dx Real-Time PCR Detection System
    LightCycler® 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels

    FAM, HEX, Cy5
    External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com
    Certification CE IVD

    *Validated instruments

     

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.43 MB]
    GP_HSV_Advisory Notice_EN_CZ
    pdf, [219.1 kB]
    GP_HSV_Instruction for Use_EN
    pdf, [1.09 MB]
    GP_HSV_Mode d'emploi_FR
    pdf, [307.63 kB]

    Declaration of Conformity

    GP_HSV_Declaration of Conformity_EN
    pdf, [610.05 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 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]
    croBEE Real-Time PCR System_EN
    pdf, [5.9 MB]
    LightCycler 480/480 Instrument II_EN
    pdf, [2.18 MB]
    LineGene 9600_9600Plus_K_EN
    pdf, [4.6 MB]
    Mic qPCR Cycler_EN
    pdf, [2.33 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]

    Product Leaflet

    GP_HSV_Leaflet_EN
    pdf, [208.93 kB]

    PCR Template

    GP_DNA_3CH_2CH_ABI7500
    edt, [10.72 kB]
    GP_DNA_3CH_2CH_AriaMx
    amxt, [3.61 kB]
    GP_DNA_3CH_2CH_croBEE
    fqt, [4.88 kB]
    GP_DNA_3CH_2CH_QS5
    edt, [8.14 kB]
    GP_DNA_BioRad
    prcl, [1.33 kB]
    GP_HSV_Mic
    micassay, [17.18 kB]
    RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]
    Files are available only for registered users.

    Order

    +420 543 211 679
    sales@geneproof.com

    Technical Support 

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

    FAQ

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