4.6 Review

The European Biological Variation Study (EuBIVAS): a summary report

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Critical appraisal and meta-analysis of biological variation estimates for kidney related analytes

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Summary: This study reviewed and updated global biological variation estimates for kidney-related markers, which were generally lower than previously reported values for all markers except urea. Some markers' BV estimates may be influenced by age or health states, but further data is needed for confirmation.

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Critical review and meta-analysis of biological variation estimates for tumor markers

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Summary: This study aims to summarize and evaluate biological variation studies for tumor markers, and examine the influence of study population characteristics and concentrations on biological variation estimates. The results indicate a lack of high-quality biological variation studies to determine the relationship between different disease states and tumor marker concentrations.

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European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum thyroid biomarkers based on weekly samplings from 91 healthy participants

Michela Bottani et al.

Summary: This study aimed to provide biological variation (BV) estimates for thyroid biomarkers, including TSH, FT4, FT3, TG, and CT. The BV estimates from this study were significantly lower than those reported in the literature, and the availability of updated BV estimates allows for refined analytical performance specifications and reference change values applicable in the diagnosis and management of thyroid disorders.

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Within- and between-subject biological variation data for tumor markers based on the European Biological Variation Study

Abdurrahman Coskun et al.

Summary: This study provides updated biological variation estimates for several tumor markers, showing significant individual differences among them. The variations of several tumor markers in pre- and postmenopausal females were significantly different.

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Jorge Diaz-Garzon et al.

Summary: This study provides robust estimates for cardiac-specific troponin I and troponin T applicable for different sampling intervals and states of health. Long-term CVI estimates were higher than short-term estimates, and estimates from diseased subjects were similar to those from healthy individuals in all settings.

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Analytical Performance Specifications for 25-Hydroxyvitamin D Examinations

Etienne Cavalier et al.

Summary: The study evaluated the biological variation of 25(OH)D to set analytical performance specifications for measurement uncertainty. The findings showed that participants were not in a steady state, so APS based on measurement uncertainty appear to be more appropriate.

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The European Biological Variation Study (EuBIVAS): Biological Variation Data for Coagulation Markers Estimated by a Bayesian Model

Aasne K. Aarsand et al.

Summary: The study used samples from the European Biological Variation Study (EuBIVAS) to determine the biological variation of coagulation markers using a Bayesian model. The results showed that for most coagulation markers, a common CVI estimate for men and women is applicable, while sex-specific reference change values should be applied for APTT, protein C, and protein S free. The use of a Bayesian model improved the interpretation and application of the data.

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Personalized Reference Intervals in Laboratory Medicine: A New Model Based on Within-Subject Biological Variation

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Summary: The study proposed a simple model to generate personalized reference intervals based on historical results, analytical and biological variation data. Increasing the number of measurements had little impact on the total variation around the true set point, and using >= 3 previous measurement results delivered robust personalized reference intervals.

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A Bayesian Approach to Biological Variation Analysis

Thomas Roraas et al.

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Systematic review of the biological variation data for diabetes related analytes

E. Gonzalez-Lao et al.

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Harmonization initiatives in the generation, reporting and application of biological variation data

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Biological Variation Estimates Obtained from 91 Healthy Study Participants for 9 Enzymes in Serum

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Mauro Panteghini et al.

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A checklist for critical appraisal of studies of biological variation

William A. Bartlett et al.

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Reliability of biological variation data available in an online database: need for improvement

Anna Carobene

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A systematic review of data on biological variation for alanine aminotransferase, aspartate aminotransferase and γ-glutamyl transferase

Anna Carobene et al.

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Biologic variability of C-reactive protein: Is the available information reliable?

Federica Braga et al.

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Comparison of the results from two different External Quality Assessment Schemes supports the utility of robust quality specifications

Anna Carobene et al.

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Reference change values: the way forward in monitoring

Callum G. Fraser

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