Validation and measurement uncertainty assessment of a microbiological method using generalized pivotal quantity procedure and monte-carlo simulation

Abstract

Recently, a novel and effective statistical tool called the uncertainty profile has been developed with the purpose of graphically assessing the validity and estimating the measurement uncertainty of analytical procedures. One way to construct the uncertainty profile is to compute the β-content, γ-confidence tolerance interval. In this study, we propose a tolerance interval based on the combination of the generalized pivotal quantity procedure and Monte-Carlo simulation. The uncertainty profile has been applied successfully in several fields. However, in order to further confirm its universality, this newer approach has been applied to assess the performance of an alternative procedure versus a reference procedure for counting of Escherichia coli bacteria in drinking water. Hence, the aims of this research were to expose how the uncertainty profile can be powerfully applied pursuant to ISO 16140 standards in the frame of interlaboratory study and how to easily make a decision concerning the validity of the procedure. The analysis of the results shows that after the introduction of a correction factor, the alternative procedure is deemed valid over the studied range because the uncertainty limits lie within the acceptability limits set at ±0.3 log unit/100 mL for a β = 66.7% and γ = 90%.