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    GeneProof BK/JC Virus (BK/JC) PCR Kit

    CE IVD
    GeneProof BK/JC Virus (BK/JC) PCR Kit

    PRODUCT ADVANTAGES

     

    MORE INFORMATION FROM ONE REACTION

    • Detects and distinguishes BK virus and JC virus in a single reaction tube
    • Enables qualitative and quantitative detection of both viruses

    CONTAMINATION PREVENTION

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

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits

    EASY-TO-USE CONCEPT

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

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CE IVD CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof BK/JC Virus (BK/JC) PCR Kit BKJC/ISEX/025 real-time PCR 25 reactions
    GeneProof BK/JC Virus (BK/JC) PCR Kit BKJC/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_BKJC_QCMD_06_22_EN_02
    pdf, [228.28 kB]
    open
    ; GP_BKJC_QCMD_06_22_EN_01
    pdf, [228.4 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 and quantitative
    Target Sequence T-Ag gene encoding large tumor antigen (BKV) and t-Ag gene encoding small tumor antigen (JCV)
    Analytical Specificity

    BK virus, 100 %
    JC virus, 100 %

    Analytical Sensitivity (LoD with 95% probability)
    Sample Processing BKV JCV
    GeneProof PathogenFree DNA Isolation Kit 218.73 IU/ml 22.89 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 522.70 IU/ml 56.56 IU/ml
    Diagnostic Specificity 100.00 % (BKV: CI95%: 67.85 % - 100.00 %; JCV: CI95%: 95.45 % - 100.00 %)
    Diagnostic Sensitivity 100.00 % (BKV: CI95%: 84.50 % - 100.00 %; JCV: CI95%: 98.65 % - 100.00 %)
    Positive Predictive Value 100.00 % (BKV: CI95%: 67.85 % - 100.00 %; JCV: CI95%: 95.45 % - 100.00 %)
    Negative Predictive Value 100.00 % (BKV: CI95%: 84.50 % - 100.00 %; JCV: CI95%: 98.65 % - 100.00 %)
    Linear Range
    Extraction method Precision BKV JCV
    GeneProof PathogenFree DNA Isolation Kit ± 0.5 log (1010 – 103) IU/ml (1010 - 102) IU/ml
    croBEE 201A Nucleic Acid Extraction Kit ± 0.5 log (1010 – 103) IU/ml (1010 - 102) IU/ml
    Dynamic Range 1010 IU/ml – LoD (LoD varying according to the extraction)
    Trueness
    (of expected concentration)
    Extraction method BKV JCV
    GeneProof PathogenFree DNA Isolation Kit -0.13 log
    (CI95%: -0.18 – -0.09)    		 0.01 log
    (CI95%: -0.07 – 0.08)
    croBEE 201A Nucleic Acid Extraction Kit -0.16 log
    (CI95%: -0.23 – -0.10)    		 0.01 log
    (CI95%: -0.08 – 0.10)
    Precision – repeatability • Intra-assay
    FAM: SD of log concentration = 0.046 (CI95%: 0.037 - 0.061)
    Cy5: SD of log concentration = 0.046 (CI95%: 0.037 - 0.060)
    Precision – reproducibility • Inter-assay
    FAM: SD of log concentration = 0.044 (CI95%: 0.028 - 0.097)
    Cy5: SD of log concentration = 0.046 (CI95%: 0.030 - 0.101)
    • Inter-lot
    FAM: SD of log concentration = 0.053 (CI95%: 0.034 - 0.116)
    Cy5: SD of log concentration = 0.055 (CI95%: 0.036 - 0.122)
    • Total
    FAM: SD of log concentration = 0.050 (CI95%: 0.032 - 0.111)
    Cy5: SD of log concentration = 0.053 (CI95%: 0.034 - 0.116)
    Reporting Units IU/ml
    Metrological Traceability

    1st WHO International Standard for BK Virus DNA (NIBSC code 14/212)
    1st WHO International Standard for JC Virus DNA (NIBSC code 14/114)
    Extraction / Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Control (IC)
    Validated Specimen CSF, plasma, urine, whole blood
    Storage -20 ± 5 °C
    Validated Extraction Method

    croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree DNA Isolation Kit
    myCROBE/croBEE 2.0 Universal Extraction Kit
    Instruments

    croBEE Real-Time PCR System
    AMPLilab Real-Time PCR System
    Applied Biosystems 7500 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 / 9600 Plus
    QuantStudio™ 5 Real-Time PCR System
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels FAM (JCV), Cy5 (BKV), HEX/JOE/VIC (IC)
    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, [1.6 MB]
    ; GP_BKJC_Instruction_for_Use_EN
    pdf, [167.74 kB]
    ; GP_BKJC_Instruction_for_Use_ES
    pdf, [169.22 kB]
    ; GP_BKJC_Instruction_for_Use_FR
    pdf, [166.57 kB]
    ; GP_BKJC_Instruction_for_Use_IT
    pdf, [169.23 kB]

    Declaration of Conformity

    ; GP_BKJC_Declaration_of_Conformity_EN
    pdf, [593.84 kB]

    MSDS

    ; GP_BKJC_Safety_Data_Sheet_EN
    pdf, [277.31 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]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    ; GP_BKJC_Leaflet_EN
    pdf, [229.72 kB]
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 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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    Technical Support 

    Send request
    +420 730 176 222
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