Review Team (February 2016)

Bio-03 (February 2016) FOR ERP USE ONLY DO NOT DISTRIBUTE

Table 3

Accuracy - Analytical bias compared to reference material

Reference value 1

SRM Product

Measured value

Code

Analyte

Bias T stat

p -value Confidence Interval

Conc. (mg/kg pwd)

(mg/kg pwd)

1.969 2.067 2.081 2.023 2.047 1.971 2.013 1.987 1.995

1849a

CLC-10b

Biotin

1.99

1.985

0.08234797 1.9856

2.0484

-

T stat =

where: = mean of the differences between measured results and reference value sd = standard deviation of the differences between results and reference value n = number of replicate analyses of SRM

H 0 : = 0, The null hypothesis is that there is no difference between the measured results and the certified value:

p -value: is the probability (at the 95% levels of confidence) of obtaining the test statistic assuming that the null hypothesis is true. p -value < 0.05 indicate a difference of statistical signifance between measured results and SRM.

95% confidence interval: The true population of the measured value expected to fall within the confidence interval estimate 95% of the time.

lower limit = mean -

upper limit = mean +

where: = critical values of the t-distribution

sd = standard deviation of the differences between results an reference value n = number of replicate analyses of SRM

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