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 journalArticlepeer-review


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


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