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    GeneProof SARS-CoV-2 Screening PCR Kit

    CE IVD myCROBE® line GP line
    GeneProof SARS-CoV-2 Screening 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 Screening PCR Kit COV2S/GP/100 real-time PCR 100 reactions
    GeneProof SARS-CoV-2 Screening PCR Kit COV2S/MC/190 real-time PCR 180 tests

    EQA Panels

    EQA results

    GP_COV2S_croBEE_QCMD_ 2020_EN
    pdf, [164.64 kB]
    open
    GP_COV2S_IRNA_QCMD_2020_EN
    pdf, [164.64 kB]
    open
    GP_COV2S_QCMD_07_21_EN
    pdf, [233.96 kB]
    open
    GP_COV2S_QCMD_10_21_EN
    pdf, [233.04 kB]
    open
    GP_COV2S_QCMD_2020_EN
    pdf, [201.27 kB]
    open
    GP_COV2S_QCMD_4_2021_EN
    pdf, [222.1 kB]
    open
    GP_CoV2S_QCMD_August_2020_EN
    pdf, [161.22 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 – 66.19 cp/ml – Qnostics SARS-CoV-2 Medium Q Control

    GeneProof Universal Nucleic Acid Extraction Kit – 51.75 cp/ml – Qnostics SARS-CoV-2 Medium Q Control

    croBEE 201A Nucleic Acid Extraction Kit – 259.72 cp/ml – Qnostics SARS-CoV-2 Medium Q Control

    Direct detection (NUCLISWAB® COVID-19 VTM) – 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 Kit
    GeneProof PathogenFree RNA Isolation Kit
    GeneProof Universal Nucleic Acid Extraction 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
    Mic qPCR Cycler
    LightCycler® 480
    LineGene 9600 Plus
    Rotor-Gene 3000 / 6000 / Q
    QuantStudio™ 5 Real-Time PCR System
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX
    External Quality Assessment tested in Instand e.V and QCMD External Quality Assessment Panels - results at www.geneproof.com
    Regulatory status

    CE IVD 

     

    Nucleic Acid Purification

     

    Medium

    GeneProof PathogenFree RNA Isolation Kit

    GeneProof Universal Nucleic Acid Extraction Kit

    croBEE NA16 Nucleic Acid Extraction System

    		 Direct detection
    Bi-CoVTM set        YES 

    ESwab

    YES

    NO

    NO

    YES

    UTM

    YES

    YES

    YES

    YES

    eNAT

    YES

    YES

    YES

    NO

    PBS

    YES

    YES

    YES

    YES
    Physiological saline solution --- --- --- YES
    Nuclease-free Water --- --- --- YES
    NUCLISWAB® COVID-19 VTM --- --- --- YES

     

    News

     

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

    SARS-CoV-2 Screening success at Pasteur Institute and Tunisia (08/19/2020)

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

    GeneProof SARS-CoV-2 PCR Screening Kit (05/18/2020)

    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_COV2S_Advisory_Notice_EN
    pdf, [471.37 kB]
    GP_COV2S_Instruction for Use_EN
    pdf, [278.08 kB]
    GP_CoV2S_Manual de Uso_ES
    pdf, [263.17 kB]
    GP_CoV2S_Mode d´emploi_FR
    pdf, [306.63 kB]
    MC_COV2S_Instruction for Use_EN
    pdf, [483.15 kB]

    Declaration of Conformity

    GPMC_COV2S_Declaration of Conformity_EN
    pdf, [594.77 kB]

    MSDS

    GP_Safety Data Sheet_EN
    pdf, [148.84 kB]

    Others

    GP_COV2S_Pasteur Institute Certificate
    pdf, [364.11 kB]

    PCR Template

    GP_COV2S_ABI7500
    edt, [10.31 kB]
    GP_COV2S_croBEE
    fqt, [4.93 kB]
    GP_COV2S_mic
    micassay, [19.14 kB]
    GP_COV2S_mic
    micassay, [19.14 kB]
    GP_COV2_ABI7500
    edt, [10.33 kB]
    GP_COV2_CFX
    prcl, [1.35 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_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_COV2S_Leaflet_EN
    pdf, [400.04 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]
    Mic qPCR Cycler_EN
    pdf, [2.33 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
    covid gpack en

    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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