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OBJECTIVES: We examined the false acceptance rate (FAR) and false rejection rate (FRR) of varying precision verification experimental designs. METHODS: Analysis of variance was applied to derive the subcomponents of imprecision (ie, repeatability, between-run, between-day imprecision) for complex matrix experimental designs (day × run × replicate; day × run). For simple nonmatrix designs (1 day × multiple replicates or multiday × 1 replicate), ordinary standard deviations were calculated. The FAR and FRR in these different scenarios were estimated. RESULTS: The FRR increased as more samples were included in the precision experiment. The application of an upper verification limit, which seeks to cap FRR at 5% for multiple experiments, significantly increased the FAR. The FRR decreases as the observed imprecision increases relative to the claimed imprecision and when a greater number of days, runs, or replicates are included in the verification design. Increasing the number or days, runs, or replicates also reduces the FAR for between-day imprecision and repeatability. CONCLUSIONS: Design of verification experiments should incorporate the local availability of resources and analytical expertise. The largest imprecision component should be targeted with a greater number of measurements. Consideration of both FAR and FRR should be given when committing a platform into service.
Lim et al. (Mon,) studied this question.
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