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    GeneProof Parvovirus B19 PCR Kit

    CE IVD
    GeneProof Parvovirus B19 PCR Kit

    PRODUCT ADVANTAGES

     

    W.H.O. STANDARD BASED QUANTIFICATION

    • Precise and fully traceable quantification according to WHO International Standard NIBSC 12/208
    • Enables reliable viral load monitoring

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one run

    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

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof Parvovirus B19 PCR Kit B19/ISEX 025 real-time PCR 25 reactions
    GeneProof Parvovirus B19 PCR Kit B19/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_B19_QCMD_04_22_EN_02
    pdf, [199.36 kB]
    open
    ; GP_B19_QCMD_04_22_EN_01
    pdf, [199.44 kB]
    open
    ; GP_B19_Instand_03_22_EN
    pdf, [1.06 MB]
    open
    ; GP_Transplatation_QCMD_01_22_EN
    pdf, [200.17 kB]
    open
    ; GP_B19_QCMD_08_21_EN_02
    pdf, [196.33 kB]
    open
    ; GP_B19_QCMD_08_21_EN_01
    pdf, [196.34 kB]
    open
    ; GP_B19_QCMD_05_21_EN_02
    pdf, [194.46 kB]
    open
    ; GP_B19_QCMD_05_21_EN_01
    pdf, [194.41 kB]
    open
    ; GP_B19_Instand_06_21_EN
    pdf, [1 MB]
    open
    ; GP_B19_Instand_03_21_EN
    pdf, [1.02 MB]
    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
    Test Principle Real-time polymerase chain reaction (PCR) – amplification of the specific Target Sequence and detection using TaqMan probes with fluorophore-based detection
    Type of Analysis Qualitative and quantitative
    Target Sequence

    Gene encoding VP1 protein (capsid protein)
    Analytical Specificity

    Parvovirus B19, 100%
    Analytical Sensitivity
    (LoD with 95% probability)    		 Sample Processing Plasma
    GeneProof PathogenFree DNA Isolation Kit 90,29 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 156,7 IU/ml
    Diagnostic Specificity 100 % (CI95%: 90.40 % - 100 %)
    Diagnostic Sensitivity 100 % (CI95%: 90.77 % - 100 %)
    Positive Predictive Value 100 % (CI95%: 90.77 % - 100 %)
    Negative Predictive Value 100 % (CI95%: 90.40 % - 100 %)
    Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)
    Reporting Units IU/ml
    Conversion Factor IU = 1 cp
    Metrological Traceability Parvovirus B19 NIBSC 12/208
    Validated Specimen Plasma, whole blood (EDTA)
    Storage Conditions (-20 ± 5 ) °C
    Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    Applied Instruments croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    Gentier 96E/96R Real-Time PCR System
    LightCycler® 480
    LineGene 9600 Plus
    Mic qPCR Cycler
    QuantStudioTM 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    StepOneTM / StepOne PlusTM Real-Time PCR System
    Detection Channels FAM (B19), HEX/JOE/VIC (IS)
    External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels - results at www.geneproof.com

    Documentation

    Instruction for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    ; GP_B19_Advisory_Notice_EN
    pdf, [1.38 MB]
    ; GP_B19_Instruction for Use_EN
    pdf, [334.07 kB]
    ; GP_B19_Instruction_for_Use_ES
    pdf, [371.56 kB]
    ; GP_B19_Instruction_for_Use_FR
    pdf, [323.57 kB]

    Declaration of Conformity

    ; GP_B19_Declaration_of_Conformity_EN
    pdf, [605.74 kB]

    MSDS

    ; GP_B19_Safety_Data_Sheet_EN
    pdf, [276.52 kB]

    PCR Template

    ; 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]
    ; GP_Parvovirus_Mic
    micassay, [22.29 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    ; GP_B19_Leaflet_EN
    pdf, [139.95 kB]
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 kB]
    ; GP_Transplatation_QCMD_01_22_EN
    pdf, [200.17 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]
    ; Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    ; SLAN Real-Time PCR System_EN
    pdf, [1.56 MB]
    ; StepOne/StepOne Plus Real-Time PCR System_EN
    pdf, [4.42 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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