Integration of data derived from biological variation into the quality management system

Ricós, Carmen; Álvarez, Virtudes; Cava, Fernando; García-Lario, José Vicene; Hernández, Amparo; Jiménez, Carlos Vı́ctor; Minchinela, Joana; Perich, Carmen; Simón, Margarita

doi:10.1016/j.cccn.2004.03.022

Cited by 13 publications

(8 citation statements)

References 8 publications

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“…Comparison of serial results can be realized using the RCV reported as percentage or as absolute value 10‐26 . The RCV represents an objective tool capable of assessing significant differences in thyroid function tests between serial measurements and allows a better test interpretation of thyroid function monitoring.…”

Section: Discussionmentioning

confidence: 99%

Biological variation and analytical goals of four thyroid function biomarkers in healthy European volunteers

Mairesse

Wauthier

Courcelles

et al. 2021

Clinical Endocrinology

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Background Interpretation of thyroid function tests by means of biological variation (BV) data is essential to identify significant changes between serial measurements at an individual level. Data on thyroid parameters in adults are limited. Objectives We aimed at determining the BV of four thyroid function test (thyroid‐stimulating hormone (TSH), free thyroxin (FT4), free triiodothyronine (FT3) and thyroglobulin (Tg)) by applying recent recommendations to acquire BV data on a latest generation of immunoassay. Methods Nineteen healthy volunteers (8 males and 11 females) were drawn every week during 5 consecutive weeks. Samples were analysed in duplicate on the Cobas 602 analyzer (Roche Diagnostics). After normality assessment, outlier exclusion and homogeneity of variance analysis, analytical variation (CVA), within‐subject biological variation (CVI) and between‐subject biological variation (CVG) were determined using nested ANOVA. Results CVA, CVI and CVG were 0.9%, 19.7% and 37.6% for TSH; 3.6%, 4.6% and 10.8% for FT4; 2.2%, 6.0% and 8.6% for FT3; and 0.9%, 15.4% and 84.9% for Tg. Index of individuality (II) for all parameters was between 0.2 and 0.7. The percentage above which the change between two measures is truly significant (reference change value) was 54.7% for TSH, 16.2% for FT4, 17.7% for FT3 and 42.8% for Tg. Conclusion Based on recent international recommendations, our study provides updated BV data for four thyroid function tests in European healthy volunteers. Reliable BV characteristics, and especially RCV, can facilitate the interpretation of consecutive thyroid function tests in an individual and therefore have the potential to efficiently support clinical decisions regarding thyroid diseases.

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Section: Discussionmentioning

confidence: 99%

Biological variation and analytical goals of four thyroid function biomarkers in healthy European volunteers

Mairesse

Wauthier

Courcelles

et al. 2021

Clinical Endocrinology

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show abstract

“…Although there is no correlation between the time interval between results and the CV I for most analytes (including albumin, glucose and thyroxine),16 the CV I increases with increasing time interval for certain analytes, e.g. cholesterol, which has its lowest CV I when the time difference is less than 1 day, and highest thereafter 4.…”

Section: Timingmentioning

confidence: 89%

Reference change values: how useful are they?

Omar

Watt²,

Pillay³

2008

J Clin Pathol

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“…The underlying reasons for using biological variation in the many situations described in this article are compelling; however, the value relies upon accurate estimates of that variation. Many investigators have produced estimates for the intra-individual (CV I ) and group (CV G ) variation, but often the needed measurement rigor and supporting information was not available [ 15 , [30] , [31] , [32] , [33] , [34] ]. For example, there have been studies conducted with small sample sizes and poorly defined groups with inappropriate statistical methods.…”

Section: Reference Intervalsmentioning

confidence: 99%

Biological variation: Understanding why it is so important?

Badrick

2021

Practical Laboratory Medicine

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Integration of data derived from biological variation into the quality management system

Cited by 13 publications

References 8 publications

Biological variation and analytical goals of four thyroid function biomarkers in healthy European volunteers

Biological variation and analytical goals of four thyroid function biomarkers in healthy European volunteers

Reference change values: how useful are they?

Biological variation: Understanding why it is so important?

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