定义实验室参考值和决定限:人群,区间范围及其解读

Defining Laboratory Reference Values and Decision Limits: Populations,Intervals,and Interpretations

简要概述多种分析人类精液检测结果的方法。参考区间(参考值范围)是最常用的解释临床实验结果的工具。参考值范围概念的发展,有赖于20世纪80年代临床化学专家国际联盟对这一概念的详尽阐述。这些指南要求:健康参考人群至少应包括120个健康个体,并对其进行分类,辨别最外延5%的参考值数据来确定双侧或单侧参考区间的界限值。最近,基于流行病学结果分析得出的决定限,也已用来解读分析检测结果。参考群体必须根据检验项目的临床使用要求严格定义:如果参考值范围用于评估男性生育能力,12个月内使配偶成功妊娠的男性应当是最合适的参考人群;如果用于精液检测结果的流行病学评估,随机选择的健康男性应该是最为理想的参考群体。虽然男性个体精液检测结果基于参考值和决定限无疑会在不久的将来成为解释结果的工具,但从长远看,解释精液检查结果的多因素方法或结合女性有关因素的分析,似乎是检测生育能力低下夫妇妊娠可能性的最佳方式。

This article provides a brief overview of various approaches that may be utilized for the analysis of human semen test results. Reference intervals are the most widely used tool for the interpretation of clinical laboratory results. Reference interval development has classically relied on concepts elaborated by the International Federation of Clinical Chemistry Expert Panel on Reference Values during the 1980s. These guidelines involve obtaining and classifying samples from a healthy population of at least 120 individuals and then identifying the outermost 5% of observations to use in defining limits for two-sided or one-sided reference intervals. More recently, decision limits based on epidemiological outcome analysis have also been introduced to aid in test interpretation. The reference population must be carefully defined on the basis of the intended clinical use of the underlying test. To determine appropriate reference intervals for use in male fertility assessment, a reference population of men with documented time to pregnancy of〈12 months would be most suitable. However, for epidemiological assessment of semen testing results, a reference population made up of unselected healthy men would be preferred. Although reference and decision limits derived for individual semen analysis test results will undoubtedly be the interpretational tools of choice in the near future, in the long term, multivariate methods for the interpretation of semen analysis alone or in combination with information from the female partner seem to represent better means for assessing the likelihood of achieving a successful pregnancy in a subfertile couple.