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The European Biological Variation Study (EuBIVAS): a summary report.
Anna Carobene1, Aasne K Aarsand2,3, William A Bartlett4
1Laboratory Medicine, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Clinical Chemistry and Laboratory Medicine
|May 28, 2021
Summary
The European Biological Variation Study (EuBIVAS) generated high-quality biological variation data for 80 measurands, including novel estimates for 10. These new biological variation estimates are often lower than previous ones, impacting laboratory medicine performance standards.
Area of Science:
- Laboratory Medicine
- Clinical Chemistry
- Biomarker Analysis
Background:
- Biological variation (BV) data are crucial for laboratory medicine applications.
- Previous BV data quality concerns prompted the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) to call for new, high-quality studies.
- The European Biological Variation Study (EuBIVAS) was established to address these quality concerns.
Purpose of the Study:
- To conduct a multicenter study generating reliable biological variation (BV) estimates.
- To provide high-quality BV data for a wide range of measurands, including novel ones.
- To update analytical performance specifications and reference change values based on new BV data.
Main Methods:
- A multicenter approach involving 6 European centers with 91 healthy individuals over 10 weeks.
- Analysis of serum/plasma samples using standardized protocols on various automated platforms (Siemens, Roche, ACL, IDS, DiaSorin).
- Application of statistical methods like CV-ANOVA and Bayesian modeling to determine BV estimates with 95% confidence intervals, including outlier, homogeneity, and trend analysis.
Main Results:
- EuBIVAS successfully generated BV estimates for 80 different measurands.
- Novel BV estimates were obtained for 10 measurands previously lacking such data (e.g., non-HDL cholesterol, S100-β protein, specific prostate antigen variants).
- BV estimates for many measurands were found to be lower than previously reported values, impacting derived performance specifications and reference change values.
Conclusions:
- The EuBIVAS study has successfully delivered high-quality biological variation data for numerous measurands.
- The new BV estimates provide a more accurate basis for establishing analytical performance specifications and reference change values in laboratory medicine.
- The findings underscore the importance of rigorous, multicenter studies for ensuring the reliability of biological variation data.
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