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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 FROM ONE REACTION

    • PCR kit detects and distinguishes Herpes Simplex Virus 1 and Herpes Simplex Virus 2 in a single reaction tube

    EXCELLENT QUALITY

    • The highest possible diagnostic sensitivity (100.00%) and diagnostic specificity (97.62%)

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

    EASY-TO-USE CONCEPT

    • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary

    CONTAMINATION PREVENTION

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

     

    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

    Product Leaflet

    Product Leaflet

    ; GP_STI_Panel_Leaflet_EN
    pdf, [1.42 MB]
    open
    ; GP_HSV_Leaflet_EN
    pdf, [230.5 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_STI II_QCMD_11_2022_EN
    pdf, [228.53 kB]
    open
    ; GP_HSV_QCMD_9_2022_EN
    pdf, [150.43 kB]
    open
    ; GP_HSV_croBEE_QCMD_9_2022_EN
    pdf, [149.74 kB]
    open
    ; GP_HSV_QCMD_05_22_EN_02
    pdf, [151.42 kB]
    open
    ; GP_HSV_QCMD_05_22_EN_01
    pdf, [151.26 kB]
    open
    ; GP_HSV_QCMD_10_21_EN_02
    pdf, [125.97 kB]
    open
    ; GP_HSV_QCMD_10_21_EN_01
    pdf, [126.08 kB]
    open
    ; GP_HSV_QCMD_06_21_EN_02
    pdf, [145.58 kB]
    open
    ; GP_HSV_QCMD_06_21_EN_01
    pdf, [145.45 kB]
    open
    ; GP_HSV_Instand_06_21_EN
    pdf, [1 MB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD
    Intended User For professional use in laboratories with trained staff
    Technology real-time PCR
    Type of Analysis qualitative and quantitative
    Target Sequence gene encoding B glycoprotein (gB)
    Analytical Specificity

    Herpes simplex virus type 1 (HSV-1), 100 %
    Herpes simplex virus type 2 (HSV-2), 100 %
    Analytical Sensitivity (LoD)
    Sample processing Type Plasma Serum Whole blood CSV
    GeneProof PathogenFree DNA Isolation Kit HSV-1 122,1 cp/ml 196,2 cp/ml 272,6 cp/ml 82,8 cp/ml
    GeneProof PathogenFree DNA Isolation Kit HSV-2 194,5 cp/ml 70,0 cp/ml 160,9 cp/ml 60,2 cp/ml
    croBEE 201A Nucleic Acid Extraction Kit HSV-1 673,7 cp/ml 302,6 cp/ml 219,2 cp/ml 642,7 cp/ml
    croBEE 201A Nucleic Acid Extraction Kit HSV-2 440,4 cp/ml 308,4 cp/ml 219,6 cp/ml 432,6 cp/ml
    Diagnostic Specificity 97.62 % (CI95%: 93.63 % – 99.23 %)
    Diagnostic Sensitivity 100.00 % (CI95%: 98.24 % – 100.00 %)
    Positive Predictive Value 98.53 % (CI95%: 96.04 % – 99.53 %)
    Negative Predictive Value 100.00 % (CI95%: 97.15 % – 100.00 %)
    Linear Range

    1010 – 102 cp/ml with precision of ± 0.5 log (GeneProof PathogenFree DNA Isolation Kit)

    1010 – 102.5 cp/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction Kit)
    Dynamic Range

    1010 – LoD cp/ml (LoD varying according to the extraction, material and channel used)
    Reporting Units

    cp/ml
    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 by Internal Standard (IS)
    Validated Specimen CSF, plasma, serum, urine, swab (genital, vesicular), whole blood (EDTA)
    Storage -20 ± 5 °C
    Validated Extraction Method

    croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX96™/ Dx Real-Time PCR Detection System
    CFX Opus 96 Real-Time PCR System
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 5 Real-Time PCR System
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels

    FAM (HSV-1), HEX/JOE/VIC (IS), Cy5 (HSV-2)
    External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_HSV12_Advisory_Notice_04_22
    pdf, [994.14 kB]
    ; GP_HSV_Advisory Notice_1_23_EN
    pdf, [413.12 kB]
    ; GP_HSV_Instruction_for_Use_EN
    pdf, [196.78 kB]
    ; GP_HSV_Instruction_for_Use_ES
    pdf, [199.09 kB]
    ; GP_HSV_Instruction_for_Use_FR
    pdf, [168.08 kB]
    ; GP_HSV_Instruction_for_Use_IT
    pdf, [292.92 kB]

    Declaration of Conformity

    ; GP_HSV_Declaration_of_Conformity_EN
    pdf, [617.95 kB]

    MSDS

    ; GP_HSV_Safety_Data_Sheet_EN
    pdf, [276.7 kB]

    Publications

    ; GP_IT_Publications_08_2022_EN
    pdf, [276.77 kB]
    ; GP_STI_publications_08_22_EN
    pdf, [204.33 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, [4.91 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]

    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]
    ; 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]
    Files are available only for registered users.

    Order

    +420 543 211 679
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    Customer Support 

    Send request
    +420 730 176 222
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    FAQ

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