Analytical performance specifications based on biological variation data - considerations, strengths and limitations
Sandberg, Sverre Coskun, Abdurrahman Carobene, Anna Fernandez-Calle, Pilar Diaz-Garzon, Jorge Bartlett, William A Jonker, Niels Galior, Kornelia Gonzales-Lao, Elisabet Moreno-Parro, Isabel
Sandberg, Sverre
Coskun, Abdurrahman
Carobene, Anna
Fernandez-Calle, Pilar
Diaz-Garzon, Jorge
Bartlett, William A
Jonker, Niels
Galior, Kornelia
Gonzales-Lao, Elisabet
Moreno-Parro, Isabel
Citations
Altmetric:
Affiliation
Other Contributors
Publication date
2024-03-20
Subject
Collections
Research Projects
Organizational Units
Journal Issue
Abstract
Analytical performance specifications (APS) are typically established through one of three models: (i) outcome studies, (ii) biological variation (BV), or (iii) state-of-the-art. Presently, The APS can, for most measurands that have a stable concentration, be based on BV. BV based APS, defined for imprecision, bias, total allowable error and allowable measurement uncertainty, are applied to many different processes in the laboratory. When calculating APS, it is important to consider the different APS formulae, for what setting they are to be applied and if they are suitable for the intended purpose. In this opinion paper, we elucidate the background, limitations, strengths, and potential intended applications of the different BV based APS formulas. When using BV data to set APS, it is important to consider that all formulae are contingent on accurate and relevant BV estimates. During the last decade, efficient procedures have been established to obtain reliable BV estimates that are presented in the EFLM biological variation database. The database publishes detailed BV data for numerous measurands, global BV estimates derived from meta-analysis of quality-assured studies of similar study design and automatic calculation of BV based APS.
Citation
Sandberg S, Coskun A, Carobene A, Fernandez-Calle P, Diaz-Garzon J, Bartlett WA, Jonker N, Galior K, Gonzales-Lao E, Moreno-Parro I, Sufrate-Vergara B, Webster C, Aarsand AK. Analytical performance specifications based on biological variation data - considerations, strengths and limitations. Clin Chem Lab Med. 2024 Mar 20;62(8):1483-1489. doi: 10.1515/cclm-2024-0108.
Type
Article