Rationale for using data on biological variation

Abstract

Abstract:The aims of this study are: 1) to use the data included in the biological variation (BV) database to address the usability of BV estimates; and 2) to use different examples from the authors' laboratories to illustrate the use and the usefulness of BV data in laboratory medicine. The BV database is an essential tool for laboratory management. Examples of application of data derived from BV are given in this paper, such as analytical performance specifications that have been included in various quality control software designed to optimize operative rules; also they have been incorporated as acceptability limits in external quality assurance reports. BV data from pathological status are of utmost interest for monitoring patients and differences between the intra-individual coefficients of variation (CV I ) estimated from healthy and patients are shown. However, for a number of analytes there are limited data available and for many there are no data, consequently new studies should be encouraged at an international level. In addition, developing international criteria to evaluate publications dealing with the estimation of BV components would be of the utmost interest. We are ready and willing to collaborate with such worthy initiatives. The first EFLM strategic conference on analytical performance specifications is an excellent opportunity for debating these ideas.

The impact of seasonal variation of 25-hydroxyvitamin D and parathyroid hormone on calcium levels

“…The present study confirmed previous studies that the calcium balance is tightly regulated into a narrow range with small intra-individual biological variation [1,2,14]. We can conclude from the present study that the minimal seasonal variation of calcium does not have any clinical relevance for physicians when interpreting analytical results relating to calcium.…”

Useful measures and models for analytical quality management in medical laboratories

“…Goals based on biologic variation are readily available from a database that was initially presented at the Stockholm conference [28] and has been updated several times through the dedicated efforts of Dr. Carmen Ricos and her colleagues from Spain [29]. The work on biologic goals was begun in the US by Cotlove, Harris, and Williams in 1970 [30], adopted in the recommendations from College of American Pathologist's 1976 Aspen Conference on Analytical Goals in Clinical Chemistry [31], greatly expanded by the many studies of Fraser [32], and adopted again by the Stockholm consensus in 1999 [3].…”

State of the art vs biological variability: Comparison on hematology parameters using Spanish EQAS data

“…Different working groups have proposed quality specifications based on BV components . These specifications are set as tolerance limits for imprecision, bias, and TE.…”

“…Different working groups have proposed quality specifications based on BV components. [11][12][13][14][15] These specifications are set as tolerance limits for imprecision, bias, and TE. However, one of the main disadvantages of this model is that it is based on biological criteria and cannot be correlated in practice with the current performance of the analyzers.…”