CLSI EP15-A3: Example 1Z

Run Ferritin (ug/L)

1 140
1 139
1 138
1 138
1 140
2 140
2 143
2 141
2 143
2 137
3 140
3 138
3 136
3 141
3 136
4 141
4 144
4 142
4 143
4 144
5 139
5 140
5 141
5 138
5
MSA: Ferritin v5.01

CLSI EP15-A3: Example 1Z

Last updated 10 August 2018 at 12:12 by Simon

Descriptives

144

143

142

141

Ferritin (ug/L)
PT sample
140

139

138

137

136
1 2 3 4 5
Run

N 24
Design 5 Run x 5 Observations

Unequal number of observations for all possible combinations of factor levels.

Assigned Uncertainty
value SE DF
PT sample 142.5 0.69 42

N Mean Mean SE Recovery

PT sample 24 140.1 0.82 98.3%
MSA: Ferritin v5.01

CLSI EP15-A3: Example 1Z

Last updated 10 August 2018 at 12:12 by Simon

Trueness

12%

8%

4%
Mean - Assigned value

Identity
_axi s Li ne
Diference (%)

0% Bi as
98.3% CI
Al l owabl
e bi as
-4% ±10%

-8%

-12%
1

Assigned value

Assigned value Mean Bias 98.3% CI Allowable bias p-value

1
142.5 140.1 -1.7% -3.8% to 0.4% ±10.0% 0.0456

H0: δ = 0
The bias is equal to 0.
H1: δ ≠ 0
The bias is not equal to 0.
1
Do not reject the null hypothesis at the 1.67% significance level.
MSA: Ferritin v5.01

CLSI EP15-A3: Example 1Z

Last updated 10 August 2018 at 12:12 by Simon

Student's t-test

Assigned value Diference SE t statistic DF p-value

142.5 -2.4 1.1 -2.25 11.1 0.0456