Scribd Logo
Upload

Welcome to Scribd!

  • 1K views

    Ep05 A3

    Uploaded by

    zinniale_89
    This document summarizes the results of a method suitability analysis for the measurement of glucose and the cancer biomarker CA19-9. For glucose, the within-laboratory standard deviation was 3.6 mg/dL and coefficient of variation was 1.5%. For CA19-9, precision was best at lower concentrations and worst at higher concentrations. The within-laboratory reproducibility coefficients of variation ranged from 2.1-8.6% depending on the sample concentration. Between-laboratory variability accounted for a significant portion of total variability for CA19-9 at higher concentrations.

    Copyright:

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

    Ep05 A3

    Uploaded by

    zinniale_89
    1K views5 pages
    This document summarizes the results of a method suitability analysis for the measurement of glucose and the cancer biomarker CA19-9. For glucose, the within-laboratory standard deviation was 3.6 mg/dL and coefficient of variation was 1.5%. For CA19-9, precision was best at lower concentrations and worst at higher concentrations. The within-laboratory reproducibility coefficients of variation ranged from 2.1-8.6% depending on the sample concentration. Between-laboratory variability accounted for a significant portion of total variability for CA19-9 at higher concentrations.

    Original Description:

    guia de la CLSI

    Original Title

    EP05-A3

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This document summarizes the results of a method suitability analysis for the measurement of glucose and the cancer biomarker CA19-9. For glucose, the within-laboratory standard deviation was 3.6 mg/dL and coefficient of variation was 1.5%. For CA19-9, precision was best at lower concentrations and worst at higher concentrations. The within-laboratory reproducibility coefficients of variation ranged from 2.1-8.6% depending on the sample concentration. Between-laboratory variability accounted for a significant portion of total variability for CA19-9 at higher concentrations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    1K views5 pages

    Ep05 A3

    Uploaded by

    zinniale_89
    This document summarizes the results of a method suitability analysis for the measurement of glucose and the cancer biomarker CA19-9. For glucose, the within-laboratory standard deviation was 3.6 mg/dL and coefficient of variation was 1.5%. For CA19-9, precision was best at lower concentrations and worst at higher concentrations. The within-laboratory reproducibility coefficients of variation ranged from 2.1-8.6% depending on the sample concentration. Between-laboratory variability accounted for a significant portion of total variability for CA19-9 at higher concentrations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    MSA: Glucose

    v4.00

    CLSI EP05-A2 - Appendix B


    Last updated 23 June 2015 at 15:07 by Simon Huntington

    Descriptives

    Glucose (mg/dL)

    252

    248

    244

    240

    236
    1

    10

    11

    12

    13

    14

    15

    16

    17

    18

    Run(Day)

    N
    Design

    80
    20 x 2 x 2

    Precision
    Mean
    244.2

    SD

    95% CI
    3.1 to 4.5

    3.6

    CV
    1.5%

    Abbreviated components

    Mean
    244.2

    Repeatability
    SD
    2.8

    Repeatability
    CV
    1.2%

    Within
    Laboratory
    SD
    3.6

    Within
    Laboratory
    CV
    1.5%

    Detailed components
    Component
    Repeatability
    Between Run
    Within Day
    Between Day
    Within Laboratory

    % of Total
    61.1%
    23.8%
    84.9%
    15.1%
    100.0%

    Exact / MLS
    95% CI
    2.3 to 3.6
    0.0 to 3.3
    3.0 to 3.9
    0.0 to 2.9
    3.1 to 4.5

    SD
    2.8
    1.8
    3.3
    1.4
    3.6

    CV
    1.2%
    0.7%
    1.4%
    0.6%
    1.5%

    ANOVA
    Effect
    Day
    Run(Day)
    Error

    SS

    DF
    415.8
    281.0
    316.0

    MS
    19
    20
    40

    Expected MS
    21.9 2Error + 22Run(Day) + 42Day
    14.1 2Error + 22Run(Day)
    7.9 2Error

    19

    20

    MSA: CA19-9

    v4.00

    CLSI EP05-A3 - Appendix B


    Last updated 25 June 2015 at 13:44 by Simon Huntington

    Descriptives
    N
    Design
    Measuring interval

    450
    6x3x5x5
    12.08 to 414.29

    Precision
    Sample
    P1
    P2
    Q3
    Q4
    P5
    Q6

    Mean
    12.08
    41.58
    55.75
    165.66
    379.09
    414.29

    SD
    1.04
    1.84
    2.29
    6.30
    9.22
    15.53

    95% CI
    0.74 to 1.77
    1.24 to 3.52
    1.43 to 5.62
    3.57 to 23.51
    6.92 to 13.83
    9.30 to 44.62

    CV
    8.6%
    4.4%
    4.1%
    3.8%
    2.4%
    3.7%

    Abbreviated components

    Mean
    12.08
    41.58
    55.75
    165.66
    379.09
    414.29

    Repeatability
    SD
    0.72
    1.28
    1.25
    2.80
    7.55
    8.60

    Repeatability
    CV
    6.0%
    3.1%
    2.2%
    1.7%
    2.0%
    2.1%

    Within
    Laboratory
    SD
    0.84
    1.33
    1.44
    3.11
    7.76
    8.77

    Within
    Laboratory
    Reproducibility Reproducibility
    CV
    SD
    CV
    6.9%
    1.04
    8.6%
    3.2%
    1.84
    4.4%
    2.6%
    2.29
    4.1%
    1.9%
    6.30
    3.8%
    2.0%
    9.22
    2.4%
    2.1%
    15.53
    3.7%

    MSA: CA19-9

    v4.00

    CLSI EP05-A3 - Appendix B


    Last updated 25 June 2015 at 13:44 by Simon Huntington

    Profile
    9%

    8%
    7%

    CV %

    6%

    Reproducibility
    Within Laboratory

    5%

    Repeatability
    = (0 + 1 U)^J

    4%
    3%
    2%
    1%
    10

    100

    CA19-9 (kU/L)

    Model 3-parameter power variance function


    Equation = (0 + 1 U)^J

    Parameter
    0
    1
    J

    Repeatability
    0.7608
    0.007583
    3.130

    -LogLikelihood

    3.6664

    Within
    Laboratory
    Reproducibility
    0.8039
    0.6291
    0.008776
    0.03376
    2.893
    1.819
    0.91577

    1.7629

    MSA: CA19-9

    v4.00

    CLSI EP05-A3 - Appendix B


    Last updated 25 June 2015 at 13:44 by Simon Huntington

    Sample P1
    Detailed components
    Component
    Repeatability
    Between Run
    Within Laboratory
    Between Laboratory
    Reproducibility

    % of Total
    48.3%
    16.4%
    64.6%
    35.4%
    100.0%

    SD
    0.72
    0.42
    0.84
    0.62
    1.04

    Exact / Satterthwaite
    95% CI
    0.61 to 0.88

    CV
    6.0%
    3.5%
    6.9%
    5.1%
    8.6%

    0.71 to 1.02
    0.74 to 1.77

    ANOVA
    Effect
    Laboratory
    Run(Laboratory)
    Error

    SS

    DF
    22.04
    16.96
    31.49

    MS
    2
    12
    60

    Expected MS
    11.02 2Error + 52Run(Laboratory) + 252Laboratory
    1.41 2Error + 52Run(Laboratory)
    0.52 2Error

    Sample P2
    Detailed components
    Component
    Repeatability
    Between Run
    Within Laboratory
    Between Laboratory
    Reproducibility

    % of Total
    48.4%
    3.6%
    52.1%
    47.9%
    100.0%

    SD
    1.28
    0.35
    1.33
    1.27
    1.84

    Exact / Satterthwaite
    95% CI
    1.09 to 1.56

    CV
    3.1%
    0.8%
    3.2%
    3.1%
    4.4%

    1.14 to 1.59
    1.24 to 3.52

    ANOVA
    Effect
    Laboratory
    Run(Laboratory)
    Error

    SS

    DF
    85.45
    27.01
    98.09

    MS
    2
    12
    60

    Expected MS
    2
    2
    2

    +
    5
    42.72 Error
    Run(Laboratory) + 25 Laboratory
    2.25 2Error + 52Run(Laboratory)
    1.63 2Error

    Sample Q3
    Detailed components
    Component
    Repeatability
    Between Run
    Within Laboratory
    Between Laboratory
    Reproducibility

    % of Total
    29.7%
    10.0%
    39.6%
    60.4%
    100.0%

    SD
    1.25
    0.72
    1.44
    1.78
    2.29

    Exact / Satterthwaite
    95% CI
    1.06 to 1.52
    1.22 to 1.76
    1.43 to 5.62

    CV
    2.2%
    1.3%
    2.6%
    3.2%
    4.1%

    ANOVA
    Effect
    Laboratory
    Run(Laboratory)
    Error

    SS

    DF
    167.06
    50.11
    93.60

    MS
    2
    12
    60

    Expected MS
    83.53 2Error + 52Run(Laboratory) + 252Laboratory
    4.18 2Error + 52Run(Laboratory)
    1.56 2Error

    MSA: CA19-9

    v4.00

    CLSI EP05-A3 - Appendix B


    Last updated 25 June 2015 at 13:44 by Simon Huntington

    Sample Q4
    Detailed components
    Component
    Repeatability
    Between Run
    Within Laboratory
    Between Laboratory
    Reproducibility

    % of Total
    19.7%
    4.7%
    24.3%
    75.7%
    100.0%

    SD

    SS
    1537.97
    205.73
    468.77

    DF

    % of Total
    67.0%
    3.7%
    70.7%
    29.3%
    100.0%

    SD

    SS
    1391.14
    874.77
    3418.02

    DF

    2.80
    1.37
    3.11
    5.48
    6.30

    Exact / Satterthwaite
    95% CI
    2.37 to 3.40

    CV
    1.7%
    0.8%
    1.9%
    3.3%
    3.8%

    2.65 to 3.77
    3.57 to 23.51

    ANOVA
    Effect
    Laboratory
    Run(Laboratory)
    Error

    2
    12
    60

    MS
    Expected MS
    768.98 2Error + 52Run(Laboratory) + 252Laboratory
    17.14 2Error + 52Run(Laboratory)
    7.81 2Error

    Sample P5
    Detailed components
    Component
    Repeatability
    Between Run
    Within Laboratory
    Between Laboratory
    Reproducibility

    7.55
    1.78
    7.76
    4.99
    9.22

    Exact / Satterthwaite
    95% CI
    6.41 to 9.19

    CV
    2.0%
    0.5%
    2.0%
    1.3%
    2.4%

    6.66 to 9.28
    6.92 to 13.83

    ANOVA
    Effect
    Laboratory
    Run(Laboratory)
    Error

    2
    12
    60

    MS
    Expected MS
    2
    2
    2

    +
    5
    695.57 Error
    Run(Laboratory) + 25 Laboratory
    72.90 2Error + 52Run(Laboratory)
    56.97 2Error

    Sample Q6
    Detailed components
    Component
    Repeatability
    Between Run
    Within Laboratory
    Between Laboratory
    Reproducibility

    % of Total
    30.7%
    1.3%
    31.9%
    68.1%
    100.0%

    SD

    SS
    8383.61
    1068.76
    4437.54

    DF

    8.60
    1.74
    8.77
    12.81
    15.53

    Exact / Satterthwaite
    95% CI
    7.30 to 10.47
    7.55 to 10.48
    9.30 to 44.62

    CV
    2.1%
    0.4%
    2.1%
    3.1%
    3.7%

    ANOVA
    Effect
    Laboratory
    Run(Laboratory)
    Error

    2
    12
    60

    MS
    Expected MS
    4191.81 2Error + 52Run(Laboratory) + 252Laboratory
    89.06 2Error + 52Run(Laboratory)
    73.96 2Error

    You might also like