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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