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    GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit

    CE IVD
    GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit

    PRODUCT ADVANTAGES

     

    DUAL TARGET DETECTION

    • Dual targeting prevents a detection failure caused by the occurrence of mutations

    SIMPLE LABORATORY WORKFLOW

    • Easily combinable with other GeneProof PCR kits in one workflow

    QUALITATIVE AND QUANTITATIVE DETECTION

    • Unique possibility to quantify viral load

    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

    • 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 Human Herpesvirus 8 (HHV-8) PCR Kit HHV8/ISEX/025 real-time PCR 25 reactions
    GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit HHV8/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_HHV8_Instand_03_22_EN
    pdf, [1.06 MB]
    open
    ; GP_HHV8_Instand_03_21_EN
    pdf, [1.02 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

    ORF26 gene, ORF73 gene
    Analytical Specificity

    0.47 cp/µl (performed on positive control)
    Diagnostic Specificity

    92.86 % (CI95%: 64.17 % - 99.63 %)
    Diagnostic Sensitivity 100.00 % (CI95%: 69.87 % - 100.00 %)
    Positive Predictive Value 92.31 % (CI95%: 62.09 % - 99.60 %)
    Negative Predictive Value 100.00 % (CI95%: 71.65 % - 100.00 %)
    Linear Range

    109 – 104 cp/ml with precision of ± 0.5 log
    Dynamic Range 109 – LoD cp/ml (LoD varying according to the extraction and material used)
    Precision - Repeatability • Intra-assay SD of log concentration = 0.063 (CI95%: 0.050 – 0.084)
    Precision - Reproducibility

    • Inter-assay SD of log concentration = 0.078 (CI95%: 0.049 – 0.191)

    • Inter-lot SD of log concentration = 0.088 (CI95%: 0.055 – 0.216)

    • Total SD of log concentration = 0.084 (CI95%: 0.052 – 0.205)
    Reporting Units

    cp/ml

    Extraction/Inhibition Control

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

    CSF, plasma, saliva, whole blood (EDTA)
    Storage

    -20 ± 5 °C

    Validated Extraction Method

    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® 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 / 5 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    Montania 4896 Real-Time PCR termocykler
    StepOne™ / StepOnePlus™ Real-Time PCR System

    Required Detection Channels

    FAM (HHV-8), HEX/JOE/VIC (IS)
    External Quality Assessment Regularly tested by in 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_HHV8_Advisory_Notice_04_22
    pdf, [989.9 kB]
    ; GP_HHV8_Instrucciones_de_Uso_ES
    pdf, [345.64 kB]
    ; GP_HHV8_Instruction_for_Use_EN
    pdf, [335.85 kB]
    ; GP_HHV8_Instruction_for_Use_IT
    pdf, [340.47 kB]

    Declaration of Conformity

    ; GP_HHV8_Declaration_of_Conformity_EN
    pdf, [614.15 kB]

    MSDS

    ; GP_HHV8_Safety_Data_Sheet_EN
    pdf, [276.21 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_HHV - 8_Mic
    micassay, [22.21 kB]
    ; RG_DNA_2CH_3CH_4CH
    ret, [13.83 kB]

    Product Leaflet

    ; GP_HHV8_Leaflet_EN
    pdf, [151.46 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]
    ; 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]
    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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