Validation and verification of measurement methods in clinical chemistry

Theodorsson, Elvar

doi:10.4155/bio.11.311

Cited by 68Clinical Laboratory Practices and Quality ControlScientific Measurement and Uncertainty EvaluationAnalytical Methods in Pharmaceuticals

Validation and verification of measurement methods in clinical chemistry

Theodorsson, Elvar·2012·Bioanalysis

DOI 10.4155/bio.11.311

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Abstract

The present overview of validation and verification procedures in clinical chemistry focuses on the use of harmonized concepts and nomenclature, fitness-for-purpose evaluations and procedures for minimizing overall measurement and diagnostic uncertainty. The need for mutually accepted validation procedures in all fields of bioanalysis becomes obvious when they implement international accreditation and certification standards or their equivalents. The guide on bioanalytical method validation published by the US FDA in 2001 represents a sensible compromise between thoroughness and cost-effectiveness. Lacking comprehensive international agreements in the field, this document has also been successfully adapted in other fields of bioanalysis. European and international efforts aiming for consensus in the entire field of bioanalysis are currently being made. Manufacturers of highly automated in vitro diagnostic methods provide the majority of measurement methods used in unmodified in clinical chemistry. Validated by the manufacturers for their intended use and fitness-for-purpose, they need to be verified in the circumstances of the end-users. As yet, there is unfortunately no general agreement on the extent of the verification procedures needed.

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Knowledge of data from full diagnostic evaluation of medical tests in practical health care will probably continue to be preferred to uncertainty estimates, despite them being complementary.
“It is probable that knowledge of data from full diagnostic evaluation 75 of medical tests [88][89][90] in practical health care will continue to be preferred to uncertainty estimates despite them being complementary.”
From Uncertainty in Measurement and Total Error (2017) · cites this paper as [75]
Natural patient samples are commutable by definition and in practice, whereas stabilized control materials may or may not be commutable.
“Natural patient samples are commutable 75 by definition and in practice, whereas stabilized control materials may or may not be commutable.”
From Uncertainty in Measurement and Total Error (2017) · cites this paper as [75]
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 [75]
Split sample methods are laborious in the absence of effective computerized systems but convenient when properly implemented.
“Split sample methods are laborious in the absence of effective computerized systems, but convenient when properly implemented.75,85”
From Uncertainty in Measurement and Total Error (2017) · cites this paper as [75]

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MethodSelf-citation

Authors: Theodorsson, E.
Affiliations: Linköping University (SE)
Corresponding author: Theodorsson, Elvar
ORCID: Theodorsson, Elvar
Venue: Bioanalysis
Publisher: Informa UK Limited
Published: 2012-02
Volume: 4
Issue: 3
Pages: 305-320
ISSN: 1757-6180 (ISSN-L)
1757-6199
DOI: 10.4155/bio.11.311
OpenAlex: W2109371353
Cited by: 68
References: 98
Citations by year: 2026: 4 · 2025: 2 · 2024: 6 · 2023: 6 · 2022: 10 · 2021: 1 · 2020: 5 · 2019: 4 · 2018: 8 · 2017: 4 · 2016: 8 · 2015: 3 · 2014: 3 · 2013: 4
FWCI: 0.34
Type: journal article
Language: en
Open access: closed
Locations: Bioanalysis (publishedVersion)
PubMed (publishedVersion)
Funders: The County Council of Östergötland
Topics: Health Sciences › Medicine › Physiology › Clinical Laboratory Practices and Quality Control
Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Scientific Measurement and Uncertainty Evaluation
Physical Sciences › Chemistry › Analytical Chemistry › Analytical Methods in Pharmaceuticals
Keywords: method validation, method verification, clinical chemistry, bioanalytical method validation, FDA guidance, fitness for purpose, measurement uncertainty, diagnostic uncertainty, international accreditation standards
MeSH terms: Accreditation, Reproducibility of Results, Clinical Chemistry Tests, Uncertainty, Validation Studies as Topic, Limit of Detection

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Validation and verification of measurement methods in clinical chemistry

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