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    GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit

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

    PRODUCT ADVANTAGES 

     

    DUAL TARGET DETECTION

    • Protection against detection failures caused by virus mutations

    QUALITATIVE AND QUANTITATIVE DETECTION

    • Monitoring of pathogen level in time
    • Full traceability to WHO standard

    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

    CERTIFIED DIAGNOSTIC TEST

    Order information

    Product name Catalog no. Technology Packaging
    GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit HIV1D/GP/025 real-time PCR 25 reactions
    GeneProof HIV type 1 (HIV-1) Diagnostic PCR Kit HIV1D/GP/100 real-time PCR 100 reactions

    Product Leaflet

    Product Leaflet

    ; GP_HIV1D_Poster_EN
    pdf, [142.92 kB]
    open
    ; GP_HIV1D_Leaflet_EN
    pdf, [133.92 kB]
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    EQA Panels

    EQA results

    ; GP_HIV1D_INSTAND_3_22_EN
    pdf, [1.06 MB]
    open
    ; GP_HIV1D_QCMD_8_22_EN
    pdf, [228.39 kB]
    open
    ; GP_HIV1D_QCMD_04_22_EN_02
    pdf, [196.38 kB]
    open
    ; GP_HIV1D_QCMD_04_22_EN_01
    pdf, [196.37 kB]
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    Technical specification

    Indication in vitro diagnostic medical device
    Regulatory Status CE1023 IVD
    Intended User For professional use in laboratories with trained staff
    Technology Real-time PCR
    Type of Analysis Qualitative and quantitative
    Target Sequence

    LTR sequence, gag/pol gene boundary and gag gene
    Analytical Specificity

    HIV subtypes A – D, AE, F, G, AG-GH, BF, H, K, CRF03_AB, Group N, Group O – 100 %
    Analytical Sensitivity (LoD with 95% probability)
    Sample Processing Plasma Serum
    GeneProof PathogenFree RNA Isolation Kit 129.6 IU/ml, i.e. 71.3 cp/ml 213.5 IU/ml, i.e. 117.4 cp/ml
    croBEE 201A Nucleic Acid Extraction Kit 404.5 IU/ml, i.e. 222.5 cp/ml 253.9 IU/ml, i.e. 139.65 cp/ml
    MagCore Automated NA Extractor 58.8 IU/ml, i.e. 32.4 cp/ml 70.6 IU/ml, i.e. 38.84 cp/ml
    Diagnostic Specificity 100 % (CI95% : 99.05 % - 100 %)
    Diagnostic Sensitivity 

    95.41 % (CI95% : 89.10 % - 98.30 %)
    Positive Predictive Value 100 % (CI95% : 95.56 % - 100.00 %)
    Negative Predictive Value 100 % (CI95% : 99.05 % - 100.00 %)
    Linear Range
    Extraction Method Precision Plasma Serum
    GeneProof PathogenFree RNA Isolation Kit ± 0.5 log 109 – 102.5 IU/ml 109 – 103 IU/ml
    croBEE 201A Nucleic Acid Extraction Kit ± 0.5 log 109 – 103 IU/ml 109 – 103 IU/ml
    MagCore Automated NA Extractor ± 0.5 log 109 – 102.5 IU/ml 109 – 103 IU/ml
    Dynamic Range

    109 IU/ml – LoD (LoD varying according to the extraction and material used)
    Trueness
    Extraction Method Plasma Serum
    GeneProof PathogenFree RNA Isolation Kit -0.02 log (CI95%: -0.10 – 0.06) -0.09 log (CI95%: -0.22 – 0.04)
    croBEE 201A Nucleic Acid Extraction Kit -0.09 log (CI95%: -0.16 – -0.01) -0.32 log (CI95%: -0.42 – -0.21)
    MagCore Automated NA Extractor -0.36 log (CI95%: -0.42 – -0.29) -0.36 log (CI95%: -0.42 – -0.31)
    Precision – Repeatability Intra-assay SD of log concentration = 0.065 (CI95%: 0.052 – 0.085)
    Precision – Reproducibility Inter-assay SD of log concentration = 0.083 (CI95%: 0.054 – 0.184)
    Inter-lot SD of log concentration = 0.076 (CI95%: 0.049 – 0.167)
    Total SD of log concentration = 0.086 (CI95%: 0.055 – 0.189)
    Reporting Units

    IU/μl
    Conversion Factor

    1 IU = 0.55 cp
    Metrological Traceability 4th HIV-1 International Standard NIBSC 16/194
    Extraction/Inhibition Control PCR inhibition, reverse-transcription efficiency and RNA extraction efficiency control by Internal Control
    Validated Specimen plasma (EDTA, citrate), serum
    Storage -20 ± 5 °C
    Validated Extraction Method croBEE 201A Nucleic Acid Extraction Kit
    GeneProof PathogenFree RNA Isolation Kit
    MagCore Automated NA Extractor
    Instruments

    croBEE Real-Time PCR System
    Applied Biosystems 7300 / 7500 Real-Time PCR System
    AriaMx Real-Time PCR System
    BioQuant-96, Fluorescent Quantitative Detection PCR system
    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_HIV1D_Instruction_for_Use_EN
    pdf, [336.95 kB]
    ; GP_HIV1D_Instruction_for_Use_FR
    pdf, [327.72 kB]

    Declaration of Conformity

    ; GP_EC_Full_Quality_Assurance_Certificate_EN
    pdf, [58.14 kB]
    ; GP_HIV1D_Declaration_of_Conformity_EN
    pdf, [633.53 kB]

    MSDS

    ; GP_HIV1D_Safety_Data_Sheet_EN
    pdf, [276.53 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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