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Repeatability imprecision from analysis of duplicates of patient samples and control materials
Karolinska Univ Hosp, Sweden.
Linköping University, Department of Biomedical and Clinical Sciences, Division of Clinical Chemistry. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Chemistry.ORCID iD: 0000-0003-0756-7723
2020 (English)In: Scandinavian Journal of Clinical and Laboratory Investigation, ISSN 0036-5513, E-ISSN 1502-7686Article in journal (Refereed) Epub ahead of print
Abstract [en]

Measurement imprecision is usually calculated from measurement results of the same stabilized control material(s) obtained over time, and is therefore, principally, only valid at the concentration(s) of the selected control material(s). The resulting uncertainty has been obtained under reproducibility conditions and corresponds to the conventional analytical goals. Furthermore, the commutability of the control materials used determines whether the imprecision calculated from the control materials reflects the imprecision of measuring patient samples. Imprecision estimated by measurements of patient samples uses fully commutable samples, freely available in the laboratories. It is commonly performed by calculating the results of routine patient samples measured twice each. Since the duplicates are usually analysed throughout the entire concentration interval of the patient samples processed in the laboratory, the result will be a weighted average of the repeatability imprecision measured in the chosen measurement intervals or throughout the entire interval of concentrations encountered in patient care. In contrast, the uncertainty derived from many measurements of control materials over periods of weeks is usually made under reproducibility conditions. Consequently, the repeatability and reproducibility imprecision play different roles in the inference of results in clinical medicine. The purpose of the present review is to detail the properties of the imprecision calculated by duplicates of natural samples, to explain how it differs from imprecision calculated from single concentrations of control materials, and to elucidate what precautions need to be taken in case of bias, e.g. due to carry-over effects.

Place, publisher, year, edition, pages
TAYLOR & FRANCIS LTD , 2020.
Keywords [en]
Dahlberg formula; analysis of variance components; repeatability; reproducibility; total variance; bias
National Category
Clinical Laboratory Medicine
Identifiers
URN: urn:nbn:se:liu:diva-163408DOI: 10.1080/00365513.2019.1710243ISI: 000505451500001PubMedID: 31899972OAI: oai:DiVA.org:liu-163408DiVA, id: diva2:1391392
Available from: 2020-02-04 Created: 2020-02-04 Last updated: 2020-02-27

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Theodorsson, Elvar
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