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    D-Dimer Co-Dd-Aps

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    Nghi Nguyen
    This document provides instructions for using a D-Dimer assay with a specific reagent and analyzer. It details the materials needed, assay parameters, measuring range, interference studies, and quality control procedures. References and lot-specific information are also included to ensure proper performance.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    D-Dimer Co-Dd-Aps

    Uploaded by

    Nghi Nguyen
    8 views4 pages
    This document provides instructions for using a D-Dimer assay with a specific reagent and analyzer. It details the materials needed, assay parameters, measuring range, interference studies, and quality control procedures. References and lot-specific information are also included to ensure proper performance.

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    D-Dimer co-dd-aps

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    This document provides instructions for using a D-Dimer assay with a specific reagent and analyzer. It details the materials needed, assay parameters, measuring range, interference studies, and quality control procedures. References and lot-specific information are also included to ensure proper performance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    8 views4 pages

    D-Dimer Co-Dd-Aps

    Uploaded by

    Nghi Nguyen
    This document provides instructions for using a D-Dimer assay with a specific reagent and analyzer. It details the materials needed, assay parameters, measuring range, interference studies, and quality control procedures. References and lot-specific information are also included to ensure proper performance.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 4

    Application Sheet for D-Dimer with HEMOSTAT D-Dimer

    HumaCLOT Pro [REF] 15800

    For additional information, please refer to the User Manual of the analyzer and check current instructions for
    use for reagents, controls, calibrators and tables of assigned/analytical values. Typical performance data can
    be found in the Verification Report of the HumaCLOT Pro, accessible via

    www.human.de/data/gb/vr/15800.pdf
    www.human-de.com/data/gb/vr/15800.pdf

    If the performance data are not accessible via internet, they can be obtained free of charge from your local
    distributor.
    The parameters defined in this application sheet have been developed to provide optimal product
    performance with the assay and instrument combination. Any modification to these parameters may affect
    performance of this and other assays in use on your system and the resulting assay values. It is the
    responsibility of the user to validate any modifications and their impact on all assay results. The application
    sheet lists all combinations of controls and calibrators for use with the reagent and instrument system; other
    combinations are not validated or supported.

    Material Required
    Material [REF] Size Position On-Board
    HEMOSTAT D-DIMER 36002
    [RGT] D-Dimer Latex reagent 1ml R4-R15
    [BUF] Reaction buffer 2,5 ml R4-R15

    [DIL] Diluent 1 ml C1 in cup


    [CAL] Calibrator 6 ml C2 in cup
    HEMOSTAT-DIMER Control High 36012 2 x 1 ml Sample rack position 01-22
    HEMOSTAT D-DIMER Control Low 36012 2 x 1 ml or position C3-C8 (when
    using QC-program)
    [WASH] HumaClot Pro Wash Solution 15800/20 15 ml W1
    [CLEAN] HumaClot Pro Cleaner 15800/30 15 ml W2
    Sample Cups (2 x 250 pieces) „Human“ or 15800/25 4 ml -
    Sample Cups (500 pieces) „Hitachi“ 17470/59 2 ml -

    Additional Notes
    If reagents, rinse solutions or buffers are not supplied in exactly fitting vials it is necessary to transfer them
    into appropriate vials. The required controls have to be transferred into appropriate sample cups.

    On-Board Stability
    Material Name in the Test Protocol Listed in the Test Setting as Time [h]
    [RGT] D-Dimer Latex reagent D-Dimer RGT Start-Reagent 72
    [BUF] Reaction buffer D-Dimer BUF Buffer / Diluent 72
    [DIL] Diluent D-Dimer DIL Calibration 8
    [CAL] Calibrator D-Dimer CAL Calibration 8
    HEMOSTAT D-DIMER Control High - Load as sample or 8
    as QC (when using QC-
    program)
    HEMOSTAT D-DIMER Control Low - Load as sample or 8
    as QC (when using QC-
    program)

    Application Sheet for D-DIMER with HEMOSTAT D-DIMER on HumaClot Pro


    Rev. 003 | 07.11.2019
    1/4
    The above stated stability data was established under controlled laboratory conditions. The above mentioned
    on-board stability values may deviate due to differences in laboratory environmental conditions.

    Interference Studies
    Threshold Values
    Triglycerides mg/dl 519 spiked normal plasma
    Hemoglobin mg/dl 100
    Bilirubin mg/dl 40

    Higher lipid values or turbid samples can result in falsely elevated or false low values. As a result, it is
    recommended to centrifuge lipemic patient samples at 15 000 x g for 10 minutes, prior to analysis.

    Measuring Range
    Valid Range 150 ng/ml to 99999 ng/ml DDU

    The total measuring range with HEMOSTAT D-DIMER covers 150 ng/ml DDU to 99.999 ng/ml DDU. This total
    measuring range is obtained through manual sample dilution, when the range of the calibration curve
    (220 ng/ml -2600 ng/ml) is exceeded.

    Example 1: If the correct sample result of an undiluted patient sample is at e.g. 3600 ng/mL, then the result is
    shown as “too high” or >2600 ng/ml. The sample needs to be re-run after manual 1:6 dilution. The obtained
    value needs to be multiplied by 6 to obtain the correct value.

    Example 2: If the correct sample result of an undiluted patient sample is at e.g. approx. 17000 ng/mL, then
    the result is shown as “too high” or >2600 ng/ml. After 1:6 dilution of the sample, the result, again, will be
    displayed as “too high” or >2600 ng/ml. The 1:6 diluted sample, subsequently, needs to be diluted 1:8 in
    order to obtain a value that lies within the calibration curve. This value needs to be multiplied by 48.

    Please Note: HEMOSTAT D-DIMER Diluent (DIL) needs to be used for all manual sample dilutions.

    Results error flag “not linear”


    Blood donor samples or samples with results well below the cut-off (200 ng/mL), may be notified as „not linear“.
    This can happen with samples showing a flat reaction kinetics and results well below the cut-off resulting in an
    error flag. In this case, a negative D-Dimer result needs to be verified, as follows:
    • Re-measurement of the sample
    • View the reaction kinetics
    • Interpretation of the reaction kinetics: a very flat curve just above zero signifies a very low DDU value
    (below cut-off).
    In comparison: a steep rise of the curve and flattening after saturation signifies a very high DDU value.

    Reference intervals vary from laboratory to laboratory depending on the population served, technique and
    reagent LOT used. Therefore, each laboratory must establish its own reference intervals or verify them
    whenever one or more of the mentioned variables are changed.

    For more information on how to establish reference intervals see CLSI document C28-A3.

    Enter the LOT numbers into the reagent settings.

    Application Sheet for D-DIMER with HEMOSTAT D-DIMER on HumaClot Pro


    Rev. 003 | 07.11.2019
    2/4
    Reagent Settings
    Screen Edit Reagent
    [REF] 36001
    Hemostat Test Hemostat D-Dimer Hemostat D-Dimer Hemostat D-Dimer
    Reagent Name D-Dimer RGT D-Dimer BUF D-Dimer DIL
    Position in List 7 8 9
    Abbreviation DDRGT DDBUF DDDIL
    LOT Please insert Lot number Please insert Lot number Please insert Lot number
    Vial 5ml-HumGL* 5ml-HumGL* Cup 1 ml
    *5ml-HumGL (5ml HUMAN Glass Bottle)

    Standard Curve Calibration


    A new standard curve must be established when changing a kit LOT, after major maintenance or service, if
    indicated by quality control results and when required by laboratory control procedures and/or government
    regulations.

    Calibration Settings
    Test Hemostat Fib
    Field Name Settings
    st
    1 conversion Interpolation
    Unit conversion mE/min -> ng/ml
    Mode: in/out lin -> lin
    Output Format xxxx.x
    Auto-Calibration
    Diluent D-Dimer DIL
    Determination 2
    Deviation 20%
    Cup Human
    Calibration Values
    0 220 ng/ml
    1 400 ng/ml
    2 800 ng/ml
    3 1600 ng/ml
    4 2600 ng/ml
    Standard
    Concentration Please insert concentration (ng/ml)*
    Name Hemostat DD CAL
    LOT Please insert LOT Number
    Convers.range 150 – 2600 ng/ml
    *refer to the Table of Analytical Values for the LOT-specific calibrator value

    Application Sheet for D-DIMER with HEMOSTAT D-DIMER on HumaClot Pro


    Rev. 003 | 07.11.2019
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    Performance Characteristics
    Method comparison
    Predicate device Regression equation r for x=200 ng/ml (Cut off)
    HEMOSTAT D-DIMER on 1,1083x-26,30 0,98 y= 195,36
    HumaCLOT DuoPlus

    Precision
    within run CV (%) run to run CV (%) total CV (%)
    BioRad Liquicheck Level 1 [ng/ml] 8,59 3,1 6,9
    D-dimer Control Level 2 [ng/ml] 2,85 1,6 2,7
    Level 3 [ng/ml] 2,39 1,4 1,9

    Application Sheet for D-DIMER with HEMOSTAT D-DIMER on HumaClot Pro


    Rev. 003 | 07.11.2019
    4/4

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