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    GeneProof JC Virus (JCV) PCR Kit

    CE IVD New product GP line
    GeneProof JC Virus (JCV) PCR Kit

    PRODUCT ADVANTAGES

    W.H.O. STANDARD BASED QUANTIFICATION

    • Precise and fully traceable quantification according to 1st WHO International Standard NIBSC JCV 14/114

    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 JC Virus (JCV) PCR Kit JCV/GP/025 real-time PCR 25 reactions
    GeneProof JC Virus (JCV) PCR Kit JCV/GP/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_JCV_Leaflet_EN
    pdf, [186.53 kB]
    open
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    EQA Panels

    EQA results

    ; GP_JC_CroBEE_QCMD_6_2022_EN
    pdf, [223.46 kB]
    open
    ; GP_JC_INSTAND_3_2022_EN
    pdf, [1.06 MB]
    open
    ; GP_JC_QCMD_6_2022_EN
    pdf, [223.25 kB]
    open
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    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 small tumor antigen
    Analytical Specificity JC Virus (JCV), 100 %

    Analytical Sensitivity (LoD with 95% probability) 
    Sample Processing CSF Plasma Whole blood
    GeneProof PathogenFree DNA Isolation Kit 8.4 IU/ml 12.6 IU/ml 34.4 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit 19.7 IU/ml 40 IU/ml 22.3 IU/ml
    Diagnosis Specificity

    97.50 % (CI95%: 85.27 % - 99.87 %)
    Diagnosis Sensitivity 100.00 % (CI95%: 84.5 % - 100.00 %)
    Positive Predictive Value 96.43 % (CI95%: 79.76 % - 99.81 %)
    Negative Predictive Value 100.00 % (CI95%: 88.83 % - 100.00 %)
    Linear Range
    Extraction Method Precision CSF Plasma Whole blood
    GeneProof PathogenFree DNA Isolation Kit ± 0.5 log (1010 – 102) IU/ml (1010 – 102) IU/ml (1010 – 102) IU/ml
    croBEE 201A Nucleic Acid Extraction Kit ± 0.5 log (1010 – 102) IU/ml (1010  – 102.5) IU/ml (1010 – 102) IU/ml
    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 -0.05 log
    (CI95%: -0.13 – 0.02)    		 -0.06 log
    (CI95%: -0.14 – 0.02)    		 -0.09 log
    (CI95%: -0.19 – 0.00)
    croBEE 201A Nucleic Acid Extraction Kit -0.08 log
    (CI95%: -0.16 – 0.00)    		 -0.03 log
    (CI95%: -0.09 – 0.03)    		 -0.12 log
    (CI95%: -0.22 – -0.02)
    Precision – Repeatability Intra-assay SD of log concentration = 0.068 (CI95%: 0.055 – 0.089)
    Precision – Reproducibility Inter-assay SD of log concentration = 0.078 (CI95%: 0.050 – 0.171)
    Inter-lot SD of log concentration = 0.094 (CI95%: 0.061 – 0.208)
    Total SD of log concentration = 0.086 (CI95%: 0.055 – 0.190)
    Reporting Units IU/ml
    Metrological Traceability 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
    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
    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® 480AriaMx Real-Time PCR System
    LineGene 9600 Plus
    Mic qPCR Cycler
    Rotor-Gene 3000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels FAM (JCV), HEX/JOE (IC)
    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_JCV_ Instruction_for_use_EN
    pdf, [351 kB]
    ; GP_JCV_Advisory Notice_EN
    pdf, [471.15 kB]
    ; GP_JCV_Instruction_for_Use_FR
    pdf, [194.63 kB]
    ; GP_JCV_Instruction_for_Use_IT
    pdf, [345.55 kB]
    ; GP_JCV_Instruction_for_Use_PT
    pdf, [194.12 kB]

    Declaration of Conformity

    ; GP_JCV_Declaration_of_conformity_EN
    pdf, [610.23 kB]

    MSDS

    ; GP_JCV_Safety_Data_Sheet_EN
    pdf, [276.68 kB]

    Publications

    ; GP_IT_Publications_08_2022_EN
    pdf, [276.77 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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    FAQ

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