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    GeneProof SARS-CoV-2 Advanced PCR Kit

    CE IVD New product
    GeneProof SARS-CoV-2 Advanced PCR Kit

    PRODUCT ADVANTAGES

     

    W.H.O. RECOMMENDED DESIGN

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

    ENDOGENOUS INTERNAL CONTROL

    • Human RNase P gene for the control of the whole diagnostic process including of proper sampling
    • Simplifies laboratory workflow

    FASTER EXAMINATION

    • Direct detection possibility with unique sampling set Bi-CoVTM
    • Fast PCR profile – less than 1 hour

    EASY-TO-USE CONCEPT

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

    CONTAMINATION PREVENTION

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

    MADE IN EUROPEAN UNION

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

     

    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 Advanced PCR Kit COV2A/GP/100 real-time PCR 100 reactions
    GeneProof SARS-CoV-2 Advanced PCR Kit COV2A/GP/025 real-time PCR 25 reactions

    Product Leaflet

    Product Leaflet

    ; GP_COV2A_Leaflet_EN
    pdf, [119.52 kB]
    open
    ; GP_COVID-19_Solution_leaflet_EN
    pdf, [279.35 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_COV2A_QCMD_03_22_EN_02
    pdf, [222.99 kB]
    open
    ; GP_COV2A_QCMD_03_22_EN_01
    pdf, [222.19 kB]
    open
    ; GP_COV2A_QCMD_07_21_EN
    pdf, [233.08 kB]
    open
    ; GP_COV2A_QCMD_11_21_EN
    pdf, [233.04 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, N and E genes
    Analytical Specificity SARS-CoV-2, 100 %

    Analytical Sensitivity 
    (LoD with 95% probability)

    Sample Processing 

    		 Channel Sensitivity Material
    GeneProof PathogenFree RNA Isolation Kit (FAM)
    FAM
    Cy5
    691.08 IU/ml
    127.24 IU/ml
    		PBS
    croBEE 201A Nucleic Acid Extraction Kit (FAM)
    FAM
    Cy5
    1404.51 IU/ml
    1654.57 IU/ml
    		PBS
    croBEE®max Nucleic Acid Extraction Kit
    FAM
    Cy5
    1127.56 IU/ml
    1779.36 IU/m
    		PBS
    Direct detection (Bi-CoV® ) (FAM) Cy5 5943.21 IU/ml Bi-CoV®
    Diagnostic Specificity 100 % (CI95%: 99.16 % – 100 %)
    Diagnostic Sensitivity 100 % (CI95%: 97.10 % – 100 %)
    Positive Predictive Value 100 % (CI95%: 97.10 % – 100 %)
    Negative Predictive Value 100 % (CI95%: 99.16 % – 100 %)
    Reporting Units IU/ml
    Metrological Traceability 1st WHO International Standard for SARS-CoV-2 RNA (NIBSC code: 20/146)
    Inhibition / Extraction Control Proper sampling, RNA extraction efficiency, reverse transcription and PCR inhibition control by endogenous Internal control (RNase P gene)
    Validated Specimen Swab in transport medium (PBS, physiological saline solution, UTM) or in Bi-CoV® or in nuclease-free water (NFW)
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    croBEE®max Nucleic Acid Extraction Kit
    GeneProof PathogenFree RNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    AriaMX Real-Time PCR System
    BioQuant-96, Fluorescent Quantitative Detection PCR system
    CFX96™/ Dx Real-Time PCR Detection system
    Gentier 96E/96R Real-time PCR system
    LightCycler® 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    QuantStudioTM 5 Real-time PCR system
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System

    External Quality Assessment

    		 Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com
    Required Detection Channels FAM (RdRp), Cy5 (E/N), HEX/VIC (RNase P)

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_COV2A_Advisory_Notice_EN
    pdf, [463.74 kB]
    ; GP_COV2A_Instructions_for_Use_SK
    pdf, [332.39 kB]
    ; GP_COV2A_Instruction_for_Use_EN
    pdf, [317.76 kB]
    ; GP_COV2A_Instruction_for_Use_ES
    pdf, [313.44 kB]
    ; GP_COV2A_Instruction_for_Use__FR
    pdf, [287.28 kB]

    Declaration of Conformity

    ; GP_COV2A_ Declaration of Conformity_EN
    pdf, [618.14 kB]

    MSDS

    ; GP_COV2A_Safety_Data_Sheet_EN
    pdf, [274.81 kB]
    ; GP_SARS-CoV-2A_Safety Data Sheet_EN
    pdf, [278.66 kB]

    Publications

    ; GP_RESPIRATORY_Publications_10_2022_EN
    pdf, [142.69 kB]

    eUni – Solutions & Families

    ; GP_COVID-19_Solution_leaflet_EN
    pdf, [279.35 kB]
    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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