Precision verification: Effect of experiment design on false acceptance and false rejection rates

Chun Yee Lim, Corey Markus, Tze Ping Loh

    Research output: Contribution to journalArticlepeer-review

    Abstract

    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.

    Original languageEnglish
    Pages (from-to)1058-1067
    Number of pages10
    JournalAmerican Journal of Clinical Pathology
    Volume156
    Issue number6
    DOIs
    Publication statusPublished - Dec 2021

    Keywords

    • Accreditation
    • Laboratory management
    • Precision
    • Validation
    • Verification

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