Intended users of this document are:

• Developers of a new measurement procedure who wish to establish its precision characteristics, be it a manufacturer that wants to distribute the product to multiple laboratories, or a clinical laboratory developing it for their own use
• End users who modify an existing assay and therefore need to reassess its precision performance
• Users who want to understand how precision performance estimates are established and/or want to perform rigorous precision assessments of their own

Manufacturers in need of advanced methods (see Appendix C) for obtaining deeper insights into the precision characteristics of a quantitative measurement procedure during assay development, optimization, and routine manufacture It is assumed that readers of this document have some familiarity with statistical data analysis, including basic analysis of variance (ANOVA), or access to statistical support resources. Section 1.5 provides a brief introduction to several of the basic concepts involved; while CLSI document EP151 includes a detailed discussion of one-way ANOVA.