Biological variation: recent development and future challenges

Biological variation (BV) data have many applications in laboratory medicine. However, these depend on the availability of relevant and robust BV data fit for purpose. BV data can be obtained through different study designs, both by experimental studies and studies utilizing previously analysed routine results derived from laboratory databases. The different BV applications include using BV data for setting analytical performance specifications, to calculate reference change values, to define the index of individuality and to establish personalized reference intervals. In this review, major achievements in the area of BV from last decade will be presented and discussed. These range from new models and approaches to derive BV data, the delivery of high-quality BV data by the highly powered European Biological Variation Study (EuBIVAS), the Biological Variation Data Critical Appraisal Checklist (BIVAC) and other standards for deriving and reporting BV data, the EFLM Biological Variation Database and new applications of BV data including personalized reference intervals and measurement uncertainty.

Automated summary

Biological variation (BV) data has various applications in laboratory medicine, but their usefulness relies on the availability of relevant and reliable BV data. BV data can be obtained through different study designs, including experimental studies and analysis of routine results from laboratory databases. The applications of BV data include setting performance specifications, calculating reference change values, defining individuality index, and establishing personalized reference intervals. This review discusses the major achievements in BV research from the past decade, such as new models and approaches for deriving BV data, the high-quality data delivered by the European Biological Variation Study (EuBIVAS), the Biological Variation Data Critical Appraisal Checklist (BIVAC) and other standards for deriving and reporting BV data, the EFLM Biological Variation Database, and new applications of BV data like personalized reference intervals and measurement uncertainty.