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Precision Verification: Effect of Experiment Design on False Acceptance and False Rejection Rates.

Authors :
Lim CY
Markus C
Loh TP
Source :
American journal of clinical pathology [Am J Clin Pathol] 2021 Nov 08; Vol. 156 (6), pp. 1058-1067.
Publication Year :
2021

Abstract

Objectives: We examined the false acceptance rate (FAR) and false rejection rate (FRR) of varying precision verification experimental designs.<br />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.<br />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.<br />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.<br /> (© American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Subjects

Subjects :
Humans
Pathology
Research Design

Details

Language :
English
ISSN :
1943-7722
Volume :
156
Issue :
6
Database :
MEDLINE
Journal :
American journal of clinical pathology
Publication Type :
Academic Journal
Accession number :
34111241
Full Text :
https://doi.org/10.1093/ajcp/aqab049