Influence of analytical and biological variation on the clinical interpretation of seminal parameters
Influence of analytical and biological variation on the clinical interpretation of seminal parameters
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DOI：
10.1093/humrep/dei423
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发表时间：
2006-04-01
影响因子：
6.1
通讯作者：
Martínez, L
中科院分区：
文献类型：
--
作者：
Castilla, JA;Alvarez, C;Martínez, L
精液分析的质量保证最近在这本杂志上受到质疑。基于精液参数在生育力测定中的有限能力，作者主张放弃精液分析的质量保证方法，以用于临床情况。在这篇文章中，我们探讨了为什么临床使用的精液分析质量保证不是“浪费时间”的论点。不精确性和受试者内生物学变异是通过分析个体精液样本获得的精液参数结果分散的两个主要组成部分。由于受试者体内的生物学变异在地理、时间和人群中是恒定的，因此不精确性是实验室检测结果质量的一个非常重要的因素。我们分析了这对各种精液参数的影响，并观察到，有一定的误差，可以容忍，而不会无效的精液参数测定的医疗用途。然而，有一个最大允许的分析误差，超过这个误差，精液参数结果的医学有用性就无效了。促进临床决策所需的性能水平称为质量规范。我们评论不同的策略来定义最大允许分析误差。
Quality assurance in semen analysis has been questioned recently in this journal. Based on the limited capacity of seminal parameter in the determination of fertility, the authors advocated abandoning methods of quality assurance in semen analysis for clinical situations. In this article, we explore arguments as to why quality assurance in semen analysis for clinical use is not 'a waste of time'. Imprecision and within-subject biological variations are the two major components involved in the dispersion of seminal parameter results obtained by analysis of a semen sample from an individual. As within-subject biological variation is constant across geography, time and population, imprecision is a very important factor in the quality of laboratory test results. We analyse this influence on various seminal parameters and observe that there is an amount of error that can be tolerated without invalidating the medical usefulness of seminal parameter determination. However, there is a maximum allowable analytical error above which the medical usefulness of seminal parameter results is invalidated. The level of performance required to facilitate clinical decision-making is termed quality specification. We comment on different strategies to define the maximum allowable analytical error.