RT Journal Article SR Electronic T1 The Generation and Applications of Biological Variation Data in Laboratory Medicine JF American Society for Clinical Laboratory Science JO Clin Lab Sci FD American Society of Chemistry and Laboratory Science SP ascls.118.000323 DO 10.29074/ascls.118.000323 A1 Niketa M Vasani A1 Biren D Patel A1 Alex Rai A1 Shashi Mehta YR 2018 UL http://hwmaint.clsjournal.ascls.org/content/early/2018/03/01/ascls.118.000323.abstract AB In recent years, increasing consideration has been given to the study of biological variation on laboratory analytes. Data on biological variation have a number of applications in the laboratory, including setting the quality specifications for analytical performance, assessing the usefulness of population-based reference ranges, assessing variation in serial results from an individual, and determining the optimal sample for analyzing a specific constituent. Thus, it is essential to generate accurate and reliable data on biological variation using a standardized study protocol. Currently, there are guidelines available to enable the standardized production of biological variation data. Here, we aim to provide recommendations on preferred experimental procedures and statistical methods for producing correct biological variation data in accordance with published guidelines.