Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching
    • /
    • search

    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, [1.61 MB]
    ; GP_BKJC_Advisory_Notice_07_22_EN
    pdf, [1.42 MB]
    ; GP_BKJC_Advisory_Notice_09_22_EN
    pdf, [413.27 kB]
    ; 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
    [obfuscate_1_|114|88|105|98|112|63|94|98|107|98|111|105|108|108|99|45|90|108|106]

    Customer Support 

    Send request
    +420 730 176 222
    [obfuscate_1_|114|108|109|109|108|113|107|61|100|98|109|92|109|111|108|110|93|43|96|108|108]

    FAQ

    News

    The biggest myths about IVDR

    Do you know the biggest myths that are connected with the new IVD Regulation?

    IVDR products available!

    All our Class „A“ products are now IVDR certified as required since May, 2022. Let’s see our offer!

    more