This chapter concerns statistical concepts and procedures that are applicable to diagnostic testing performed in the clinical laboratory. Three important laboratory issues are addressed: the estimation of analytical imprecision, the design of an effective laboratory quality control strategy, and the establishment of population reference ranges. These three topics were selected because each demonstrates a valuable statistical principle. Estimation of analytical imprecision highlights the important role of study design. Evaluating laboratory quality control strategies emphasizes the importance of choosing appropriate statistical models. The estimation of population reference ranges demonstrates that there can be many different approaches to developing good statistical estimators.
