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Linearity assessment: deviation from linearity and residual of linear regression approaches
Singapore Inst Technol, Singapore.
Singapore Inst Technol, Singapore.
Hanoi Med Univ, Vietnam; Natl Childrens Hosp, Vietnam.
Flinders Univ S Australia, Australia.
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2024 (English)In: Clinical Chemistry and Laboratory Medicine, ISSN 1434-6621, E-ISSN 1437-4331, Vol. 62, no 10, p. 1918-1927Article in journal (Refereed) Published
Abstract [en]

In this computer simulation study, we examine four different statistical approaches of linearity assessment, including two variants of deviation from linearity (individual (IDL) and averaged (AD)), along with detection capabilities of residuals of linear regression (individual and averaged). From the results of the simulation, the following broad suggestions are provided to laboratory practitioners when performing linearity assessment. A high imprecision can challenge linearity investigations by producing a high false positive rate or low power of detection. Therefore, the imprecision of the measurement procedure should be considered when interpreting linearity assessment results. In the presence of high imprecision, the results of linearity assessment should be interpreted with caution. Different linearity assessment approaches examined in this study performed well under different analytical scenarios. For optimal outcomes, a considered and tailored study design should be implemented. With the exception of specific scenarios, both ADL and IDL methods were suboptimal for the assessment of linearity compared. When imprecision is low (3 %), averaged residual of linear regression with triplicate measurements and a non-linearity acceptance limit of 5 % produces <5 % false positive rates and a high power for detection of non-linearity of >70 % across different types and degrees of non-linearity. Detection of departures from linearity are difficult to identify in practice and enhanced methods of detection need development.

Place, publisher, year, edition, pages
WALTER DE GRUYTER GMBH , 2024. Vol. 62, no 10, p. 1918-1927
Keywords [en]
linearity; imprecision; method verification; method validation; method evaluation
National Category
Medical Laboratory Technologies
Identifiers
URN: urn:nbn:se:liu:diva-206328DOI: 10.1515/cclm-2023-1354ISI: 001282355200001PubMedID: 39026453Scopus ID: 2-s2.0-85199298662OAI: oai:DiVA.org:liu-206328DiVA, id: diva2:1889598
Available from: 2024-08-16 Created: 2024-08-16 Last updated: 2025-08-15Bibliographically approved

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Theodorsson, Elvar

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CiteExportLink to record
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  • apa
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