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    GeneProof HIV type 1 (HIV-1) PCR Kit

    CE 1023 IVD
    GeneProof HIV type 1 (HIV-1) PCR Kit

    PRODUCT ADVANTAGES 

     

    HIGH DIAGNOSTIC SPECIFICITY AND SENSITIVITY

    • Diagnostic sensitivity was verified on 128 HIV positive plasma samples acquired from Centre for AIDS Reagents (CFAR), National Institute for Biological Standards and Control (NIBSC)
    • Diagnostic specificity was verified on 500 HIV negative samples

    DUAL TARGET DETECTION

    • Dual targeting prevents detection failure caused by possible mutations inside the HIV-1 genome

    DETECTS A BROAD SPECTRUM OF HIV-1 SUBTYPES

    • HIV genotypes A - D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB

    EASY-TO-USE CONCEPT

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

    CONTROL OF THE WHOLE DIAGNOSTIC PROCESS

    • RNA extraction, reverse transcription and PCR amplification

     

    COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

    CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof HIV type 1 (HIV-1) PCR Kit HIV1/ISEX/025 real-time PCR 25 reactions
    GeneProof HIV type 1 (HIV-1) PCR Kit HIV1/ISEX/100 real-time PCR 100 reactions

    EQA Panels

    EQA results

    ; GP_HIV_QCMD_08_21_EN_02
    pdf, [219.16 kB]
    open
    ; GP_HIV_QCMD_08_21_EN_01
    pdf, [222.53 kB]
    open
    ; GP_HIV_Instand_03_21_EN
    pdf, [1.02 MB]
    open
    Choose all

    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE1023IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative and quantitative
    Target Sequence

    LTR sequence and GaG gene
    Analytical Specificity

    HIV genotypes A - D, AE, F, AG-GH, Group N, Group O, BF, H, K, CRF03_AB, 100%
    Analytical Sensitivity (LoD with 95% probability)

    Reaches up to 273.971 IU/ml i.e. 153.424 cp/ml (on HIV-1 NIBSC 16/194 using manual extraction GeneProof PathogenFree RNA Isolation Kit)


    Reaches up to 548.121 IU/ml i.e. 306.948 cp/ml (on HIV-1 NIBSC 16/194 using automatic extractor croBEE NA16 Nucleic Acid Extraction System)


    Reaches up to 98.59 IU/ml i.e. 55.21 cp/ml (on Acrometrix HIV-1 Panel IU/ml using manual extraction SpinStar Viral Nucleic Acid Kit 1.0 with SpinStar Pretreatment Solution)
    Diagnostic Specificity 100 % (CI95 % : 99.10 % - 100 %)
    Diagnostic Sensitivity 

    93.66 % (CI95 % : 87.96 % - 96.88 %)
    Linear Range

    109– 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree RNA Isolation Kit)
    109– 103 IU/ml with precision of ± 0.5 log (using automatic extractor croBEE NA16 Nucleic Acid Extraction
    System)
    Dynamic Range

    109 – 273.971 IU/ml (using manual extraction GeneProof PathogenFree RNA Isolation Kit)
    109 – 548.121 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
    Reporting Units

    IU/ml
    Conversion Factor

    1 IU = 0.56 cp
    Metrological Traceability HIV NIBSC 16/194
    Extraction/Inhibition Control PCR inhibition and RNA extraction efficiency control (ISEX version)
    Validated Specimen Plasma
    Storage -20 ± 5 °C
    Validated Extraction Method croBEE 201A Nucleic Acid Extraction System
    GeneProof PathogenFree RNA Isolation Kit
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
    LightCycler® 2.0 / 480
    LineGene 9600 / 9600 Plus
    Mic qPCR Cycler
    QuantStudio™ 3 Real-Time PCR System
    Rotor-Gene 3000 / 6000 / Q
    SLAN® Real-Time PCR System
    Required Detection Channels FAM, HEX
    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_HIV1_Advisory Notice_EN
    pdf, [571.83 kB]
    ; GP_HIV1_Instruction for Use_EN
    pdf, [223.28 kB]
    ; GP_HIV1_Manual de Uso_ES
    pdf, [224.81 kB]
    ; GP_HIV1_Mode d'emploi_FR
    pdf, [240.98 kB]

    Declaration of Conformity

    ; GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [417.58 kB]
    ; GP_HIV1_Declaration_of_Conformity_EN
    pdf, [606.74 kB]
    ; GP_HIV1_EC _Design_Examination Certificate_EN
    pdf, [364.23 kB]
    ; GP_HIV1_EC_Design_Examination_Certificate_EN
    pdf, [345.7 kB]

    MSDS

    ; GP_HIV_Safety_Data_Sheet_EN
    pdf, [277.24 kB]

    PCR Template

    ; GP_HIV-1_Mic
    micassay, [14.73 kB]
    ; GP_HIV1_ABI7500
    edt, [10.33 kB]
    ; GP_HIV1_AriaMx
    amxt, [3.63 kB]
    ; GP_HIV1_CroBee
    fqt, [4.93 kB]
    ; GP_HIV1_QS3
    edt, [8.01 kB]
    ; GP_HIV1_QS5
    edt, [8.07 kB]
    ; GP_HIV_1_BioRad
    prcl, [1.38 kB]
    ; RG_HIV_1
    ret, [14.31 kB]

    Product Leaflet

    ; GP_HIV1_Leaflet_EN
    pdf, [131.25 kB]

    Manual

    ; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
    pdf, [1.43 MB]
    ; Mic qPCR Cycler_EN
    pdf, [2.33 MB]
    ; Rotor-Gene_3000_6000_Q_EN
    pdf, [2.22 MB]
    ; SLAN Real-Time PCR System_EN
    pdf, [1.53 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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