Test results comparison: is the S-Monovette® Lithium-Heparin Gel plus a suitable replacement for the S-Monovette® Lithium-Heparin Gel on Alinity Abbott®?

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.