PD ISO/TS 27878:2023

Reproducibility of the level of detection (LOD) of binary methods in collaborative and in-house validation studies. | Status: Current

1 Scope This document provides statistical techniques for the determination of the reproducibility of the level of detection for

1. a) binary (qualitative) test methods for continuous measurands, e.g. the content of a chemical substance, and
2. b) binary (qualitative) test methods for discrete measurands, e.g. the number of RNA copies in a sample.

The reproducibility precision is determined according to ISO 5725 (all parts). Precision estimates are subject to random variability. Accordingly, it is important to determine the uncertainty associated with each estimate, and to understand the relationship between this uncertainty, the number of participants and the experimental design. This document thus provides not only a description of statistical tools for the calculation of the LOD reproducibility precision, but also for the standard error of the estimates.