La variabilità biologica: le basi teoriche e l’esperienza dei Gruppi di Lavoro della Federazione Europea di Chimica Clinica e Medicina di Laboratorio

AUTORI

ABSTRACT

Biological Variation: theoretical bases and the experience of the EFLM working groups

In laboratory medicine, the test results of a subject vary over the time due to three factors: pre-analytical variation, analytical variation, and intra-individual biological variation (BV) that depends on the subject physiology. Appropriately, quantified and characterized BV data have many applications. Besides the setting of performance specifications, the data can also be used to define significance of change between measurements within a subject, and to assess the utility of conventional population-based reference intervals. Given the importance of BV data, it is clear that the access to them is essential for the clinical laboratory, and that users should be confident that they are well characterized and fit for purpose. To make the data accessible, a BV database has been made available via the Westgard website. However, in recent years, concerns have been raised about the quality of the published BV data. To address some of the concerns, the EFLM Task and Finish Group on Biological Variation has developed the Biological Variation Data Critical Appraisal Checklist (BIVAC), with the aim to verify whether publications in the field have included all essential elements that may influence the veracity of associated BV estimates. Moreover, to address the need to deliver new reliable data, the EFLM Working Group on BV has designed and initiated the European Biological Variation Study (EuBIVAS) to obtain high-quality BV estimates for the highest possible number of measurands. The aim of this review, in addition to an overview about the theory of BV, is to describe BIVAC rationale and to present new BV estimates obtained by EuBIVAS.

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