Biological variation data: An important old topic with new standards and new look resources

What is it about?

This article is designed highlights recent work in the important area of biological variation of clinical laboratory test resuts within and between subjects. Biological variation data have many important applications in clinical laboratory medicine that include identification of required performance specifications of assays used to deliver results, iden tifying the utility of population based reference intervals and in identifying significance of change in consecutive test results within subjects.

Featured Image

Photo by Testalize.me on Unsplash

Photo by Testalize.me on Unsplash

Why is it important?

Accrediation of clinical laboratories to the EN ISO15189 2022 standard requires quality management systems designed to manage risk and deliver patient centerdness. Delivering examinations that utilise analytical methods that meet required analytical perfomance and delver results and reports that can be correctly interpreted are therefore important areas for focus.. The article signposts service providers to quality assessed data biological variation for use in thse contexts and highlights iportant initiatives aimed and increasing the understanding of biological variation data and their application

Perspectives

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Biological variation data are in fact reference data. As such there is a requirment that they should be made availabble to users accompanied by a minimum data set to enable their transportability into clinical practice across time, populations and health care systems. A standards requirment also emerges from this perspective for both data production and reoprting. The article explorese these issues and points users towards work being undertaken to enable reporting of quality assesed data accompanied by mininmum data set. It adreeses the standards issue including reference to the recently proposed standards for reporting biological variation data studies (STARBIV). There is an ongoing drive to ensure that existing biological variation studies have delivered data sets that meet a standard and are accessible in a published format to enable safe and effective applications (www.biologicalvariation.eu). New inititiatives such as STARBIV provide tools to drive up the quality of future studies to expand the database and also deliver educational materials to increase the knowledge of those those using these important reference data.

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