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    GeneProof SARS-CoV-2 PCR Kit

    CE IVD
    GeneProof SARS-CoV-2 PCR Kit

    PRODUCT ADVANTAGES

     

    HIGH SPECIFICITY AND SENSITIVITY

    • Excellent QCMD panel results
    • 100% diagnostic sensitivity and specificity

    W.H.O. RECOMMENDED DESIGN

    • Three targets (RdRp/E/N genes) in one reaction
    • Confirmation in an independent channel
    • Reliable detection of all virus variants
    • Triple protection against detection failures caused by virus mutations

    UNIQUE INTERNAL CONTROL CONSTRUCTION

    • Internal control imitates natural virus particle
    • Control of the whole diagnostic process including viral nucleoproteine lysis, RNA extraction, reverse transcription and PCR amplification
    • Enables full control of any non-isolation sample pretreatment

    EASY-TO-USE CONCEPT

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

    CONTAMINATION PREVENTION

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

    MADE IN EU

    • Developed and manufactured in the Czech Republic, the member of the EU

     

    Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof Flu Multiplex PCR Kit.

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof SARS-CoV-2 PCR Kit COV2/GP/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_COV2_croBEE_QCMD_2020_ EN
    pdf, [164.44 kB]
    open
    GP_COV2_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    GP_COV2_Instand_06_21_EN
    pdf, [1 MB]
    open
    GP_COV2_Instand_06_21_EN_01
    pdf, [1 MB]
    open
    GP_COV2_Instand_06_21_EN_02
    pdf, [1 MB]
    open
    GP_COV2_IRNA_QCMD_2020_EN
    pdf, [164.57 kB]
    open
    GP_CoV2_QCMD _August_2020_EN
    pdf, [161.22 kB]
    open
    GP_COV2_QCMD_07_21_EN
    pdf, [233.96 kB]
    open
    GP_COV2_QCMD_10_21_EN
    pdf, [233.08 kB]
    open
    GP_COV2_QCMD_2020_ EN
    pdf, [201.23 kB]
    open
    GP_COV2_QCMD_4_2021_EN
    pdf, [222.05 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
    Type of Analysis qualitative
    Target sequence RdRp gene, E gene and N gene
    Analytical Specificity SARS-CoV-2, 100 % , detection is based on the method recommended by WHO (Corman et al, 2020)
    Analytical Sensitivity (LoD with 95% Probability)

    GeneProof PathogenFree RNA Isolation Kit – FAM 75.49 cp/ml – Cy5 364.82 cp/ml – Qnostics SARS-CoV-2 Medium Q Control

    GeneProof Universal Nucleic Acid Extraction Kit – FAM 59.95 cp/ml – Cy5 349.34 cp/ml – Qnostics SARS-CoV-2 Medium Q Control

    croBEE 201A Nucleic Acid Extraction Kit – FAM 314.44 cp/ml –Cy5 612.27 cp/ml – Qnostics SARS-CoV-2 Medium Q Control

    Direct detection (NUCLISWAB® COVID-19 VTM) – FAM, Cy5 519 cp/ml – Traceability to Qnostics SARS-CoV-2 Medium Q Control
    Diagnostic specificity 100% (CI95%: 95.25% - 100%)
    Diagnostic sensitivity 100% (CI95%: 91.58% - 100%)
    Positive predictive value 100% (CI95%: 91.58% - 100%)
    Negative predictive value 100% (CI95%: 95.25% - 100%)
    Extraction/Inhibition Control

    PCR inhibition and RNA extraction efficiency control 
    Validated Specimen swab, transport medium, saliva
    Transport medium: ESwab, UTM, eNAT, PBS, Physiological saline solution, Nuslease-free Water, NUCLISWAB®
    COVID-19 VTM, Transport medium (Vircell), Bi-CoVTM set
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree RNA Isolation Kit
    GeneProof Universal Nucleic Acid Extraction 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 Plus
    Rotor-Gene 3000
    Rotor-Gene Q
    QuantStudio™ 5 Real-Time PCR System
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX, Cy5
    External Quality Assessment tested in Instand e.V. and QCMD External Quality Assessment Panels - results at www.geneproof.com
    Regulatory status CE IVD 

    News

    New Covid-19 • Flu • RSV GPack (08/28/2020)

    Success of GeneProof SARS-CoV-2 in QCMD (06/09/2020)

    New GeneProof SARS-CoV-2 PCR Kit (04/15/2020)

     

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.49 MB]
    GP_Advisory Notice_CoV2_CoV2S_CZ_EN
    pdf, [399.15 kB]
    GP_COV2_Advisory_Notice_EN
    pdf, [474.27 kB]
    GP_COV2_Instruction for Use_EN
    pdf, [277.63 kB]
    GP_COV2_Manual de Uso_ES
    pdf, [285.69 kB]
    GP_COV2_Mode d´emploi_FR
    pdf, [305.11 kB]

    Declaration of Conformity

    GP_COV2_Declaration of conformity_EN
    pdf, [554.33 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 kB]

    PCR Template

    GP_COV2_ABI7500
    edt, [10.33 kB]
    GP_COV2_CFX
    prcl, [1.35 kB]
    GP_COV2_croBEE
    fqt, [4.97 kB]
    GP_COV2_LC480
    ixo, [9.5 kB]
    GP_COV2_RG
    ret, [14.88 kB]
    GP_FAST_2CH_3CH_AriaMx
    amxt, [3.52 kB]
    GP_FAST_2CH_3CH_CroBee
    fqt, [4.91 kB]
    GP_FAST_BioRad
    prcl, [1.31 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_3CH_2CH_QS5
    edt, [8.13 kB]
    GP_UNI_BioRad
    prcl, [1.33 kB]
    RG_UNI_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_COV2_Leaflet_EN
    pdf, [405.71 kB]
    GP_COVID-19_Solution_leaflet_EN
    pdf, [279.35 kB]
    GP_Covid19_GPack_Leaflet_ EN
    pdf, [1.26 MB]

    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]
    Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    SLAN Real-Time PCR System_EN
    pdf, [1.56 MB]
    Files are available only for registered users.

    Gallery

    zvětšit
    GP_SARS_CoV_2_PCR_Kit
    zvětšit
    covid gpack en
    zvětšit

    Order

    +420 543 211 679
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    Technical Support 

    Send request
    +420 730 176 222
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    FAQ

    News

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