Clin Chem Lab Med. 2015 May;53(6):871-7. doi: 10.1515/cclm-2014-1133.
Biological variation (BV) data enable assessment of the significance of changes in serial measurements observed within a subject and are used to set analytical quality specifications. This data is available in a database held in Westgard website (http://www.westgard.com/biodatabase1.htm). Some limitations of this data, however, have been identified in recent published reviews. The aim of this paper is to show the reliability of the published BV data and to identify ongoing works to address some of its limitations.
The BV data currently hosted on the Westgard website was examined. Distribution of measurands stratified by the number of cited references upon which the database entry is based and the distribution of papers stratified by publication year, are shown. Moreover, BV data available in literature for glycated hemoglobin, C-reactive protein, glycated albumin, alanine aminotransferase, aspartate aminotransferase and γ-glutamyl transferase are evaluated.
The results obtained show that most BV data come just from a few papers or only one paper and that a lot of publications are dated, therefore this data is too obsolete to be used. Furthermore critical review of the BV database highlights a number of factors that might impact on the reliability of the BV data entries and translation into current practice.
A number of issues clearly undermine the value of the current database. These issues are being considered by the European Federation of Clinical Chemistry and Laboratory Medicine, biological variation working group, in collaboration with a Spanish group responsible for the database updating.
生物学变异（BV）数据可用于评估个体内连续测量观察到的变化的显著性，并用于设定分析质量规范。这些数据可在 Westgard 网站（http://www.westgard.com/biodatabase1.htm）的数据库中获得。然而，最近发表的评论已经指出了该数据的一些局限性。本文旨在展示已发表的 BV 数据的可靠性，并确定正在进行的工作，以解决其中一些局限性。
检查了当前驻留在 Westgard 网站上的 BV 数据。展示了按参考文献数量分层的测定物分布情况，这些文献是数据库条目的基础，还展示了按出版物年份分层的论文分布情况。此外，还评估了文献中可用于糖化血红蛋白、C 反应蛋白、糖化白蛋白、丙氨酸氨基转移酶、天冬氨酸氨基转移酶和γ-谷氨酰转移酶的 BV 数据。
所得结果表明，大多数 BV 数据仅来自少数几篇论文或仅一篇论文，而且许多出版物的日期都很陈旧，因此这些数据太陈旧，无法使用。此外，对 BV 数据库的批判性审查突出了一些可能影响 BV 数据条目可靠性并将其转化为当前实践的因素。
一些问题显然降低了当前数据库的价值。这些问题正在欧洲临床化学和实验室医学联合会生物变异工作组与负责数据库更新的西班牙小组合作考虑中。
