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    GeneProof Varicella-Zoster Virus (VZV) PCR Kit

    CE IVD
    GeneProof Varicella-Zoster Virus (VZV) PCR Kit

    PRODUCT ADVANTAGES

     

    EXCELLENT QUALITY

    • The highest possible diagnostic sensitivity (100.00%) and diagnostic specificity (97.44%)

    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

    • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible 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 Varicella-Zoster Virus (VZV) PCR Kit VZV/ISEX/025 real-time PCR 25 reactions
    GeneProof Varicella-Zoster Virus (VZV) PCR Kit VZV/ISEX/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_VZV_Leaflet_EN
    pdf, [170.95 kB]
    open
    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 kB]
    open
    Choose all

    EQA Panels

    EQA results

    ; GP_VZV_croBEE_QCMD_8_2022
    pdf, [143.06 kB]
    open
    ; GP_VZV_INSTAND_6_2022
    pdf, [1.06 MB]
    open
    ; GP_VZV_QCMD_8_2022
    pdf, [143.63 kB]
    open
    ; GP_VZV_QCMD_05_22_EN_02
    pdf, [144.09 kB]
    open
    ; GP_VZV_QCMD_05_22_EN_01
    pdf, [143.97 kB]
    open
    ; GP_VZV_QCMD_09_21_EN_02
    pdf, [139.48 kB]
    open
    ; GP_VZV_QCMD_09_21_EN_01
    pdf, [139.5 kB]
    open
    ; GP_VZV_QCMD_06_21_EN_02
    pdf, [138.85 kB]
    open
    ; GP_VZV_QCMD_06_21_EN_01
    pdf, [138.8 kB]
    open
    ; GP_VZV_Instand_06_21_EN
    pdf, [1 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

    Technology

    Real-time PCR

    Type of Analysis

    Qualitative and quantitative

    Target Sequence

    Gene ORF62

    Analytical Specificity

    Varicella-zoster virus (VZV), 100%

    Analytical Sensitivity (LoD)
    Sample Processing Plasma Serum Whole blood CSV
    GeneProof PathogenFree DNA Isolation Kit 113,1 cp/ml 66,1 cp/ml 119,9 cp/ml 66,4 cp/ml
    croBEE 201A Nucleic Acid Extraction Kit 218,8 cp/ml 166,5 cp/ml 170,4 cp/ml 175,1 cp/ml
    Diagnostic Specificity 97.44 % (CI95%: 84.92 % - 99.87 %)
    Diagnostic Sensitivity 100.00 % (CI95%: 97.52 % - 100.00 %)
    Positive Predictive Value 99.47 % (CI95%: 96.65 % - 99.97 %)
    Negative Predictive Value 100.00 % (CI95%: 88.57 % - 100.00 %)

    Linear Range

     1010 – 102.5 cp/ml with precision of ± 0.8 log
    Dynamic Range 1010 – LoD cp/ml (LoD varying according to the extraction and material used)
    Precision - Repeatability • Intra-assay SD of log concentration = 0.076 (CI95%: 0.061 – 0.099)
    Precision - Reproducibility

    • Inter-assay SD of log concentration = 0.079 (CI95%: 0.051 – 0.174)

    • Inter-lot SD of log concentration = 0.081 (CI95%: 0.052 – 0.177)

    • Total SD of log concentration = 0.081 (CI95%: 0.052 – 0.179)
    Trueness (of expected concentration)

    -0.01 log (CI95%: -0.15 – 0.14) using manual extraction GeneProof PathogenFree DNA Isolation Kit

    -0.07 log (CI95%: -0.15 – 0.00) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit

    Reporting Units

     cp/ml

    Metrological Traceability

    AcroMetrixTM VZV Plasma Panel (cat. no. 954530)

    Extraction/Inhibition Control

    PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)

    Validated Specimen

    		 CSF, plasma, serum, whole blood (EDTA), vesicular swab

    Storage

    -20 ± 5 °C

    Validated Extraction Method

    croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree DNA Isolation Kit

    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 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    StepOneTM / StepOne PlusTM Real-Time PCR System
    SLAN® Real-Time PCR System

    Required Detection Channels

    FAM (VZV), HEX/JOE/VIC (IS)

    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_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
    pdf, [508.26 kB]
    ; GP_VZV_Advisory_Notice_04_22
    pdf, [1.01 MB]
    ; GP_VZV_Instrucciones_de_Uso_ES
    pdf, [348.87 kB]
    ; GP_VZV_Instruction_for_Use_EN
    pdf, [363.06 kB]
    ; GP_VZV_Instruction_for_Use_IT
    pdf, [170.99 kB]

    Declaration of Conformity

    ; GP_VZV_Declaration of Conformity_EN
    pdf, [581.93 kB]

    MSDS

    ; GP_VZV_Safety_Data_Sheet_EN
    pdf, [276.86 kB]

    Publications

    ; GP_IT_Publications_08_2022_EN
    pdf, [276.77 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_VZV_Mic
    micassay, [22.17 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 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 2.0_EN
    pdf, [1.8 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]
    ; 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]

    eUni – Solutions & Families

    ; GP_IT_Panel_Leaflet_EN
    pdf, [275.02 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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