PT  - JOURNAL ARTICLE
AU  - Vasani, Niketa M
AU  - Patel, Biren D
AU  - Rai, Alex
AU  - Mehta, Shashi
TI  - The Generation and Applications of Biological Variation Data in Laboratory Medicine
AID  - 10.29074/ascls.118.000323
DP  - 2018 Jan 01
TA  - American Society for Clinical Laboratory Science
PG  - ascls.118.000323
4099  - http://hwmaint.clsjournal.ascls.org/content/early/2018/03/01/ascls.118.000323.short
4100  - http://hwmaint.clsjournal.ascls.org/content/early/2018/03/01/ascls.118.000323.full
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.