XP ISO/TS 27878, X06-083 (05/2023)

This document provides statistical techniques for determining the reproducibility of the level of detection for: a) binary (qualitative) test methods for continuous measurands, for example in the content of a chemical substance; b) binary (qualitative) testing methods for discrete measurands, for example in the number of RNA copies in a sample. Reproducibility accuracy is determined in accordance with ISO 5725 (all parts). Precision estimates are subject to random variability. Therefore, it is important to determine the uncertainty associated with each estimate and understand the relationship between this uncertainty, the number of participants, and the experimental design. To this end, this document describes statistical tools not only for calculating the precision of LOD reproducibility, but also for the standard error of the estimates.
(Automatic translation from French)