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

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Aarsand A. K., Roraas T., Bartlett W. A., COŞKUN A., Carobene A., Fernandez-Calle P., ...More

CLINICAL CHEMISTRY AND LABORATORY MEDICINE, vol.56, no.10, pp.1629-1636, 2018 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Review
  • Volume: 56 Issue: 10
  • Publication Date: 2018
  • Doi Number: 10.1515/cclm-2018-0058
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.1629-1636
  • Keywords: analytical performance specification, biological variation, evidence-based medicine, meta-analysis, reference change values, REFERENCE CHANGE VALUES, LABORATORY MEDICINE, EUROPEAN FEDERATION, CLINICAL-CHEMISTRY, CRITICAL-APPRAISAL, CHECKLIST, PROJECT, HEALTHY, SERUM, MODEL
  • Acibadem Mehmet Ali Aydinlar University Affiliated: Yes


Biological variation (BV) data have many applications in laboratory medicine. However, concern has been raised that some LW 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.