1 Scope
This document provides statistical techniques for the determination of the reproducibility
of the level of detection for
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a) binary (qualitative) test methods for continuous measurands, e.g. the content of a chemical substance, and
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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.