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    GeneProof SARS-CoV-2 PCR Kit

    CE IVD
    GeneProof SARS-CoV-2 PCR Kit

    PRODUCT ADVANTAGES

     

    UNIQUE 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

    MADE IN EU

    • Developed and manufactured in the Czech Republic, the member of the European Union

    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

     

    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_QCMD_07_21_EN
    pdf, [233.96 kB]
    open
    GP_COV2_QCMD_10_21_EN
    pdf, [233.08 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_QCMD_4_2021_EN
    pdf, [222.05 kB]
    open
    GP_COV2_IRNA_QCMD_2020_EN
    pdf, [164.57 kB]
    open
    GP_COV2_croBEE_QCMD_2020_ EN
    pdf, [164.44 kB]
    open
    GP_CoV2_QCMD _August_2020_EN
    pdf, [161.22 kB]
    open
    GP_COV2_QCMD_2020_ EN
    pdf, [201.23 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD / EC Directive 98/79/EC
    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 %
    Analytical Sensitivity (LoD with 95% Probability)

    Sample Processing 

    		 Sensitivity Material
    GeneProof PathogenFree RNA Isolation Kit (FAM) 381.28 IU/ml PBS
    croBEE 201A Nucleic Acid Extraction Kit (FAM) 1600.41 IU/ml PBS
    Direct detection (Bi-CoV®) (FAM) 2589.8 IU/ml Anterior nasal swab in Bi-CoV®
    Diagnostic specificity 100% (CI95%: 95.68% - 100%)
    Diagnostic sensitivity 100% (CI95%: 91.58% - 100%)
    Positive predictive value 100% (CI95%: 91.58% - 100%)
    Negative predictive value 100% (CI95%: 95.68% - 100%)
    Reporting Units IU/ml
    Metrological Traceability 1st WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146)
    Extraction/Inhibition Control

    PCR inhibition and RNA extraction efficiency control by Internal Control (IC)
    Validated Specimen Nasopharyngeal swab in transport media UTM (Copan), PBS or physiological saline solution
    Anterior nasal swab, saliva in Bi-CoV®
    Anterior nasal swab in nuclease-free water (NFW)
    Storage -20 ± 5 °C
    Validated Extraction Methods ccroBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree RNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System
    AMPLilab Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX96™/ Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR 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/JOE/VIC, Cy5
    External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com

    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, [1.55 MB]
    GP_Advisory Notice_CoV2_CoV2S_CZ_EN
    pdf, [399.15 kB]
    GP_COV2_Advisory_Notice_01_22_EN_CZ
    pdf, [546.98 kB]
    GP_COV2_Advisory_Notice_EN
    pdf, [474.27 kB]
    GP_COV2_Instruction for Use_EN
    pdf, [286.07 kB]

    Declaration of Conformity

    GP_COV2_Declaration of conformity_EN
    pdf, [554.33 kB]

    MSDS

    GP_COV2_Safety_Data_Sheet_EN
    pdf, [286 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, [240.86 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

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