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    GeneProof Bordetella pertussis/parapertussis PCR Kit

    CE IVD
    GeneProof Bordetella pertussis/parapertussis PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION WITH LESS SAMPLES

    • Detects and distinguishes Bordetella pertussis and Bordetella parapertussis in a single reaction tube

    HIGHLY SPECIFIC DETECTION

    • Amplification of the multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS1001 (specific only for B. parapertussis)
    • No false-positive results for Bordetella holmesii

    EASY-TO-USE CONCEPT

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

    CONTAMINATION PREVENTION

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

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Bordetella pertussis/parapertussis PCR Kit BP/ISEX/025 real-time PCR 25 reactions
    GeneProof Bordetella pertussis/parapertussis PCR Kit BP/ISEX/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_BP_Leaflet_EN
    pdf, [162.84 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_BP_QCMD_09_20_EN_02
    pdf, [197.16 kB]
    open
    ; GP_BP_QCMD_09_20_EN_01
    pdf, [198.71 kB]
    open
    ; GP_BP_Instand_06_21_EN
    pdf, [901.17 kB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative
    Target Sequence The multi-copy insertion sequences IS1002 (specific for both Bordetella pertussis/parapertussis) and IS10001 (specific only for B. parapertussis)
    Analytical Specificity

    B. pertussis, 100 %
    B. parapertussis, 100 %
    Analytical Sensitivity (LoD with 95% probability) 0.212 cp/µl (on Amplirun® Bordetella pertussis DNA control, Vircell)
    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control 
    Validated Specimen

    Aspirate, sputum, swab
    Storage

    -20 ± 5 °C
    Validated Extraction Methods

    croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    AriaMx Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7500 Real-Time PCR System
    BioQuant-96 Real-Time PCR Systemm
    CFX96™ / Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 5 Real-Time PCR System
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Detection Channels

    FAM, HEX/JOE/VIC, Cy5
    External Quality Assessment Regularly tested in QCMD and Instand e.V. External Quality Assessment panels - for results see www.geneproof.com

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_BP_Advisory_Notice_EN
    pdf, [853.68 kB]
    ; GP_BP_Instructions_for_Use_ES
    pdf, [171.82 kB]
    ; GP_BP_Instructions_for_Use_IT
    pdf, [169.16 kB]
    ; GP_BP_Instruction_for_Use_EN
    pdf, [285.03 kB]
    ; GP_BP_Instruction_for_Use_PT
    pdf, [136.27 kB]

    Declaration of Conformity

    ; GP_BP_Declaration_of_Conformity_EN
    pdf, [573.69 kB]

    MSDS

    ; GP_BP_Safety Data Sheet_EN
    pdf, [274.64 kB]

    Publications

    ; GP_RESPIRATORY_Publications_10_2022_EN
    pdf, [142.69 kB]

    PCR Template

    ; GP_Bordetella pertussis_parapertussis_Mic
    micassay, [28.03 kB]
    ; GP_DNA_3CH_2CH_ABI7500
    edt, [10.72 kB]
    ; GP_DNA_3CH_2CH_AriaMx
    amxt, [3.61 kB]
    ; GP_DNA_3CH_2CH_croBEE
    fqt, [4.91 kB]
    ; GP_DNA_3CH_2CH_QS5
    edt, [8.14 kB]
    ; GP_DNA_BioRad
    prcl, [1.33 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    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]
    ; 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]
    ; QuantStudio 3/5 Real-Time PCR System_EN
    pdf, [1.81 MB]
    ; Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    ; SLAN Real-Time PCR System_EN
    pdf, [1.56 MB]
    ; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
    pdf, [4.2 MB]
    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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