Bias in clinical chemistry

Theodorsson, Elvar; Magnusson, Bertil; Leito, Ivo

doi:10.4155/bio.14.249

Cited by 73Clinical Laboratory Practices and Quality ControlScientific Measurement and Uncertainty EvaluationReliability and Agreement in Measurement

Bias in clinical chemistry

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Theodorsson, Elvar, Magnusson, Bertil, Leito, Ivo·2014·Bioanalysis

DOI 10.4155/bio.14.249

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Abstract

Clinical chemistry uses automated measurement techniques and medical knowledge in the interest of patients and healthy subjects. Automation has reduced repeatability and day-to-day variation considerably. Bias has been reduced to a lesser extent by reference measurement systems. It is vital to minimize clinically important bias, in particular bias within conglomerates of laboratories that measure samples from the same patients. Small and variable bias components will over time show random error properties and conventional random-error based methods for calculating measurement uncertainty can then be applied. The present overview of bias presents the general principles of error and uncertainty concepts, terminology and analysis, and suggests methods to minimize bias and measurement uncertainty in the interest of healthcare.

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Even after the advent of accreditation standards ISO 17025 and 15189 demanding uncertainty calculations, top-down variance component analysis used in error/frequentist statistics are commonly used for uncertainty estimation using internal quality control samples.
“Even after the advent of accreditation standards ISO 17025 and 15189 demanding uncertainty calculations, top-down variance component analysis used in error/frequentist statistics are commonly used for uncertainty estimation using internal quality control samples.75,76”
From Uncertainty in Measurement and Total Error (2017) · cites this paper as [76]
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Authors: Theodorsson, E., Magnusson, B., & Leito, I.
Affiliations: Linköping University (SE)
RISE Research Institutes of Sweden (SE)
University of Tartu (EE)
ORCID: Theodorsson, Elvar
Leito, Ivo
Venue: Bioanalysis
Publisher: Informa UK Limited
Published: 2014-11
Volume: 6
Issue: 21
Pages: 2855-2875
ISSN: 1757-6180 (ISSN-L)
1757-6199
DOI: 10.4155/bio.14.249
OpenAlex: W2037120565
Cited by: 73
References: 93
Citations by year: 2026: 3 · 2025: 4 · 2024: 7 · 2023: 6 · 2022: 1 · 2021: 9 · 2020: 7 · 2019: 6 · 2018: 11 · 2017: 8 · 2016: 8 · 2015: 2 · 2014: 1
FWCI: 0.74
Type: journal article
Language: en
Open access: green
urn.kb.se
Licence: other-oa
Locations: Bioanalysis (publishedVersion)
PubMed (publishedVersion)
KTH Publication Database DiVA (KTH Royal Institute of Technology) (submittedVersion, other-oa)
Topics: Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Reliability and Agreement in Measurement
Keywords: measurement bias, clinical chemistry, measurement uncertainty, random error, repeatability, day-to-day variability, reference measurement system, laboratory network, bias mitigation
MeSH terms: Automation, Humans, Laboratories, Quality Control, Reproducibility of Results, Clinical Chemistry Tests, Uncertainty

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