Analytical performance specifications based on biological variation data - considerations, strengths and limitations

TY - JOUR

T1 - Analytical performance specifications based on biological variation data - considerations, strengths and limitations

AU - Sandberg, Sverre

AU - Coskun, Abdurrahman

AU - Carobene, Anna

AU - Fernandez-Calle, Pilar

AU - Diaz-Garzon, Jorge

AU - Barlett, William A.

AU - Jonker, Niels

AU - Galior, Kornelia

AU - Gonzales-Lao, Elisabet

AU - Moreno-Parro, Isabel

AU - Sufrate-Vergara, Berta

AU - Webster, Craig

AU - Aarsand, Aasne K.

N1 - Publisher Copyright: © 2024 the author(s), published by De Gruyter, Berlin/Boston.

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - analytical performance specifications

KW - bias

KW - biological variation

KW - measurement uncertainty

KW - precision

KW - total error

UR - https://www.scopus.com/pages/publications/85190303042

U2 - 10.1515/cclm-2024-0108

DO - 10.1515/cclm-2024-0108

M3 - Article

C2 - 38501489

SN - 1434-6621

VL - 62

SP - 1483

EP - 1489

JO - Clinical Chemistry and Laboratory Medicine

JF - Clinical Chemistry and Laboratory Medicine

IS - 8

ER -