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    GeneProof BK Virus (BKV) PCR Kit

    CE IVD New product GP line
    GeneProof BK Virus (BKV) PCR Kit

    PRODUCT ADVANTAGES

    W.H.O. STANDARD BASED QUANTIFICATION

    • Precise and fully traceable quantification according to 1st WHO International Standard NIBSC BKV 14/212
    • Enables reliable viral load monitoring

    EASY-TO-USE CONCEPT

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

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

    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 BK Virus (BKV) PCR Kit BKV/GP/025 real-time PCR 25 reaction
    GeneProof BK Virus (BKV) PCR Kit BKV/GP/100 real-time PCR 100 reaction

    Product Leaflet

    Product Leaflet

    ; GP_Transplantation_QCMD_01_22_EN
    pdf, [200.17 kB]
    open
    ; GP_BKV_Leaflet_EN
    pdf, [118.26 kB]
    open
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    EQA Panels

    EQA results

    ; GP_BKV_Crobee_QCMD_11_22_EN
    pdf, [214.15 kB]
    open
    ; GP_BKV_QCMD_06_22_EN
    pdf, [226.5 kB]
    open
    ; GP_BKV_Instand_03_22_EN
    pdf, [1.06 MB]
    open
    ; GP_Transplantation_QCMD_01_22_EN
    pdf, [200.17 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 and quantitative
    Target Sequence T-Ag gene encoding large tumor antigen
    Analytical Specificity BK virus (BKV), 100 %

    Analytical Sensitivity (LoD with 95% probability) 
    Sample Processing CSF Plasma Whole blood
    GeneProof PathogenFree DNA Isolation Kit 240.9 IU/ml 297.0 IU/ml 251.8 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 532.1 IU/ml 644.7 IU/ml 908.6 IU/ml
    Diagnosis Specificity

    100.00 % (CI95%: 86.27 % – 100.00 %)
    Diagnosis Sensitivity 96.30 % (CI95%: 79.11 % – 99.81 %)
    Positive Predictive Value 100.00 % (CI95%: 83.98 % – 100.00 %)
    Negative Predictive Value 96.88 % (CI95%: 82.00 % – 99.84 %)
    Linear Range 1010 – 103 IU/ml with precision of ± 0.5 log (using manual or automatic extraction from plasma, CSF
    and whole blood)
    Dynamic Range 1010 – LoD IU/ml (LoD varying according to the extraction and material used)
    Trueness (of expected concentration)
    Extraction Method CSF Plasma Whole blood
    GeneProof PathogenFree DNA Isolation Kit -0.11 log
    (CI95%: -0.20 – -0.02)    		 -0.07 log
    (CI95%: -0.14 – -0.01)    		 -0.04 log
    (CI95%: -0.14 – -0.01)
    croBEE 201A Nucleic Acid Extraction Kit -0.12 log
    (CI95%: -0.23 – -0.01)    		 -0.06 log
    (CI95%: -0.12 – 0.00)    		 -0.07 log
    (CI95%: -0.15 – 0.00)
    Precision – Repeatability Intra-assay SD of log concentration = 0.061 (CI95%: 0.050 – 0.080)
    Precision – Reproducibility Inter-assay SD of log concentration = 0.112 (CI95%: 0.072 – 0.246)
    Inter-lot SD of log concentration = 0.206 (CI95%: 0.133 – 0.454)
    Total SD of log concentration = 0.243 (CI95%: 0.157 – 0.536)
    Reporting Units IU/ml
    Conversion Factor 1 IU = 1 cp
    Metrological Traceability 1st WHO International Standard for BK virus DNA (NIBSC code 14/212)
    Extraction/Inhibition Control

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

    Validated Extraction Methods

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

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AMPLilab Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96 Real-Time PCR System
    Gentier 96E/96R Real-Time PCR System
    Mic qPCR Cycler
    CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
    LineGene 9600 Plus
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX/JOE
    External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com

    Instructions for Use

    ; Declaration of Verification of the kits with medical devices
    pdf, [1.61 MB]
    ; GP_BKV_Advisory_Notice_05_22_EN
    pdf, [466.91 kB]
    ; GP_BKV_Instruction_for_Use_EN
    pdf, [346.28 kB]
    ; GP_BKV_Instruction_for_Use_FR
    pdf, [198.52 kB]

    Declaration of Conformity

    ; GP_BKV_Declaration_of_conformity_EN
    pdf, [619.9 kB]

    MSDS

    ; GP_BKV_Safety_Data_Sheet_EN
    pdf, [276.42 kB]
    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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