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    GeneProof Flu Multiplex PCR Kit

    CE IVD
    GeneProof Flu Multiplex PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION WITH LESS SAMPLES

    • Detects and distinguishes Influenza A, Influenza B and RSV in a single reaction tube
    • Suitable for differential diagnostics of infectious agents causing Flu and Flu-like symptoms

    WHO RECOMMENDED DESIGN

    • Dual target detection of Influenza A (NP gene/M gene) and Influenza B

    SINGLE TUBE READY-TO-USE MASTER MIX

    • Contains all components for PCR amplification
    • No additional PCR reagents pipetting necessary

    HIGH SPECIFICITY

    • Detects all currently known Influenza A serotypes including H1N1, H1N1pdm09, H3N2, H5N8 and H7N
    • Detects both Influenza B lineages Victoria and Yamagata
    • Detects RSV A and RSV B

    CONTAMINATION ELIMINATION

    • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

     

    Beneficial in Covid-19 • Flu • RSV GPack combination with GeneProof SARS-CoV-2 PCR Kit or GeneProof SARS-CoV-2 Screening 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 Flu Multiplex PCR Kit FLU/GP/025 real-time PCR 25 reactions
    GeneProof Flu Multiplex PCR Kit FLU/GP/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    GP_FLU_QCMD_09_20_EN_02
    pdf, [138.84 kB]
    open
    GP_FLU_QCMD_09_20_EN_01
    pdf, [139.79 kB]
    open
    GP_FLU_Instand_06_21_EN
    pdf, [1 MB]
    open
    GP_FLU_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    GP_RSV_Instand_06_21_EN
    pdf, [1 MB]
    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 specific region in M gene and NP gene for Influenza A virus
    two specific regions in HA gene for Influenza B virus
    specific region in M gene for Respiratory syncytial virus A and B
    Analytical Specificity Influenza A virus, Influenza B virus and Respiratory syncytial virus A and B, 100 %
    Analytical Sensitivity (LoD)

    reaches up to 25.75 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control,
    Qnostics, using manual extraction GeneProof PathogenFree RNA Isolation Kit)
    reaches up to 161.64 cp/ml with the probability of 95 % for Influenza A virus (on INFA Medium Q Control,
    Qnostics, using automatic extraction croBEE NA16 Nucleic Acid Extraction System)
    reaches up to 7.25 cp/μl with the probability of 95 % for Influenza B virus (on Amplirun® Influenza B RNA
    control, Vircell)
    reaches up to 43.57 cp/μl with the probability of 95 % for Respiratory syncytial virus (on Amplirun® RSV A RNA
    control, Vircell)
    Diagnostic Specificity 100.00% (CI95%: 79.95%–100.00%)
    Diagnostic Sensitivity 92.31% (CI95%: 80.60%–97.51%)
    Extraction/Inhibition Control

    PCR inhibition and RNA extraction efficiency control 
    Validated Specimen aspirate, BAL, swab, transport medium: Sigma MM*, Sigma Virocult*
    Storage -20 ± 5 °C
    Validated Extraction Methods croBEE NA16 Nucleic Acid Extraction System
    GeneProof PathogenFree RNA Isolation Kit
    Instruments

    ccroBEE Real-Time PCR System**
    Applied Biosystems 7500 Real-Time PCR System
    CFX96™/ Dx Real-Time PCR Detection System
    AriaMx Real-Time PCR System
    LineGene 9600 Plus
    Required Detection Channels FAM, HEX, Cy5, TexRed
    External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
    Certification CE IVD 

    * Only in combination with GeneProof PathogenFree RNA Isolation Kit
    ** Validated instrument

    News

     

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

    Documentation

    Instruction for Use

    Declaration of Verification of the kits with medical devices
    pdf, [1.55 MB]
    GP_FLU_Instruction for Use_EN
    pdf, [78.37 kB]

    Declaration of Conformity

    GP_FLU_Declaration of Conformity_EN
    pdf, [305.54 kB]

    MSDS

    GP_FLU_Safety_Data_Sheet_EN
    pdf, [274.7 kB]

    PCR Template

    GP_UNI_4CH_3CH_2CH_AriaMx
    amxt, [3.72 kB]
    GP_UNI_4CH_ABI7500
    edt, [10.36 kB]
    GP_UNI_4CH_CroBee
    fqt, [4.94 kB]
    GP_UNI_BioRad
    prcl, [1.33 kB]
    RG_UNI_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    GP_Covid19_GPack_Leaflet_ EN
    pdf, [1.26 MB]
    GP_FLU_Leaflet_EN
    pdf, [90.18 kB]

    Manual

    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]
    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

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