APR January/February 2022 - 60

» MICROBIOLOGY
»
Figure 1. Accuracy, Precision, and Equivalency Experimental Design
Verifying equivalence with respect to accuracy implies the study of
the distribution of measurement values with respect to location (i.e.
the mean.). Motivated by PDA TR 33(18
), the non-inferiority hypothesis
H1 " rFC accuracy is non-inferior to LAL accuracy " relates to the mean
recoveries of the rFC and the LAL method as follows:
The acceptance criterion for non-inferiority is derived from the
hypothesis test decision rule of rejecting the hypothesis H0
, that is,
requiring that the lower limit of the one-sided 95% confidence interval
for the ratio of the mean recoveries (blue horizontal line Figure 2(a)) is
greater than 70% (orange vertical line Figure 2(a)).
Verifying equivalence with respect to (intermediate) precision implies
the study of the distribution of rFC measurement values with respect
to variability. The corresponding non-inferiority hypothesis H1
states
Figure 2. Illustrated Hypothesis Test Problems for Equivalence: Accuracy and Precision
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APR January/February 2022

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