Allowable Imprecision for Laboratory Tests Based on Clinical and Analytical Test Outcome Criteria

The allowable imprecision for laboratory tests has been estimated from criteria based on clinical and analytical test outcome. The analytical outcome criteria studied are the Clinical Laboratory Improvement Amendments (CLIA) criteria for proficiencytesting. The clinical outcome criteria are estimates of medically significant changes in test re-sultstaken from a study in the literature. The estimates of allowable imprecision were obtained from quality-plan-fling models that relate test outcome criteria to the allow-able amount of imprecision and inaccuracy and to the quality controlthat is necessary to assure achievement of the desired outcome criteria in routine operation. These operating specifications for imprecision are consistently more demanding (require lower CV5) than the medically useful CVs originally recommended in the literature be