Selection of within‐run quality control rules for laboratory biomarkers

In order to release correct biomarker results of a laboratory test, it is a regulatory requirement to apply quality control standards for controlling analytical errors. Releasing an incorrect test result might lead to wrong diagnosis or treatment of a patient in medical decision‐making. In laborator...

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Bibliographic Details
Published in:Statistics in medicine 2021-07, Vol.40 (16), p.3645-3666
Main Authors: Laubender, Ruediger Paul, Geistanger, Andrea
Format: Article
Language:English
Subjects:
Biomarkers
companion diagnostics
individualized medicine
Laboratories
laboratory test
Process controls
Quality control
statistical process control
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Summary:In order to release correct biomarker results of a laboratory test, it is a regulatory requirement to apply quality control standards for controlling analytical errors. Releasing an incorrect test result might lead to wrong diagnosis or treatment of a patient in medical decision‐making. In laboratory medicine, one of the means to control analytical errors is statistical process control procedures proposed by James O. Westgard and his coworkers nowadays known as “Westgard rules.” To judge their performance for discriminating in‐control from out‐of‐control processes, power curves are used. In this article, we describe functions for the power curves of the within‐run Westgard rules. Based on these power curves, we use a benchmark approach for selecting a quality control procedure out of the set of Westgard rules. It is shown that two graphical procedures proposed by Westgard and his coworkers can be reduced to this benchmark approach. Besides, a commonly used measure in laboratory medicine for describing out‐of‐control processes is critically examined revealing the threat of selecting too optimistic quality control rules.
ISSN:0277-6715
1097-0258
DOI:10.1002/sim.8987