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

AK Aarsand, T Røraas, WA Bartlett, A Coşkun, A Carobene, P Fernandez-Calle, N Jonker, J Díaz-Garzón, F Braga, S Sandberg, European Federation of Clinical Chemistry, Laboratory Medicine (EFLM) Working Group on Biological Variation

Research output: Contribution to journalArticle


Biological variation (BV) data have many applications in laboratory medicine. However, concern has been raised that some BV estimates in use today may be irrelevant or of unacceptable quality. A number of initiatives have been launched by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and other parties to deliver a more harmonized practice in the generation, reporting and application of BV data. Resulting from a necessary focus upon the veracity of historical BV studies, critical appraisal and meta-analysis of published BV studies is possible through application of the Biological Variation Data Critical Appraisal Checklist (BIVAC), published in 2017. The BIVAC compliant large-scale European Biological Variation Study delivers updated high-quality BV data for a wide range of measurands. Other significant developments include the publication of a Medical Subject Heading term for BV and recommendations for common terminology for reporting of BV data. In the near future, global BV estimates derived from meta-analysis of BIVAC appraised publications will be accessible in a Biological Variation Database at the EFLM website. The availability of these high-quality data, which have many applications that impact on the quality and interpretation of clinical laboratory results, will afford improved patient care. © 2018 Walter de Gruyter GmbH, Berlin/Boston.
Original languageEnglish
Pages (from-to)1629-1636
Number of pages8
JournalClinical Chemistry and Laboratory Medicine
Issue number10
Publication statusPublished - 2018


Cite this

Aarsand, AK., Røraas, T., Bartlett, WA., Coşkun, A., Carobene, A., Fernandez-Calle, P., Jonker, N., Díaz-Garzón, J., Braga, F., Sandberg, S., Chemistry, E. F. O. C., & Variation, L. M. EFLM. W. G. O. B. (2018). Harmonization initiatives in the generation, reporting and application of biological variation data. Clinical Chemistry and Laboratory Medicine, 56(10), 1629-1636. https://doi.org/10.1515/cclm-2018-0058