Rethinking the use of “one-way ANOVA” in CLSI EP15-A3–a call for terminological precision and methodological clarity
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C Ma, L Qiu
Clinical Chemistry and Laboratory Medicine (CCLM …, 2025
degruyterbrill.com
In clinical laboratory method validation, the CLSI EP15-A3 guideline [1] has long served as a practical standard for verifying precision claims made by manufacturers. However, one specific aspect of this document merits critical reconsideration–namely, its repeated reference to the use of “one-way ANOVA” for estimating precision metrics such as repeatability and within-laboratory precision. While functionally convenient, this terminology is statistically imprecise and, more importantly, conceptually misleading. The underlying …