Aguilar J, Alvarez C, Morancho-Zaragoza J, Prats-Gimenez R, Ramírez J P, Fernández-Pardo E, Martínez L, Calafell R, Duran I, Castilla J A
Banco de Semen CEIFER, Granada, Spain.
Scand J Clin Lab Invest. 2008;68(1):68-76. doi: 10.1080/00365510701496470. Epub 2007 Nov 21.
The aim of this study was to identify analytical quality specifications for seminal parameters based on clinicians' opinions, and to compare with those based on biological variability and state of the art.
Two questionnaires with case histories were sent to laboratories participating in the Spanish programme of external quality on semen analysis for distribution to as many specialist clinicians as possible. Our intention was to determine the critical difference (CD), defined as the difference needed between two consecutive results obtained from semen analysis to be 95 % confident that the two results actually are different. Subsequently, we calculated the specifications of analytical quality in accordance with the clinicians' opinions.
The CDs obtained from the median value of the differences between the initial value and that given in the clinicians' replies were similar in clinical situations of improvement or worsening in the infertile normozoospermic male, and also in worsening situations for male patients presenting a significant alteration in seminal parameters. For improvement in this latter case, the CD cited as necessary in the clinicians' opinion was much higher than that for the other clinical situations. At a desirable level of quality, for concentration and total motility the coefficients of variation in the clinicians' opinion were below those based on biological variability and the state of the art. However, for type "a+b" motility, type "a" motility, morphology and vitality the coefficients of variation based on the clinicians' opinions were higher than those based on biological variability and lower than those based on the state of the art.
Quality specifications for seminal parameters based on clinicians' opinions depend to a large extent on the clinical situation and on the seminal parameter being analysed.
本研究旨在根据临床医生的意见确定精液参数的分析质量规范，并与基于生物学变异和现有技术的规范进行比较。
向参与西班牙精液分析外部质量计划的实验室发送了两份附有病例史的问卷，以便分发给尽可能多的专科临床医生。我们的目的是确定临界差值（CD），其定义为精液分析获得的两个连续结果之间所需的差值，以95%的置信度确定这两个结果实际上是不同的。随后，我们根据临床医生的意见计算了分析质量规范。
从初始值与临床医生回复中给出的值之间的差值中位数获得的临界差值，在不育的正常精子男性改善或恶化的临床情况中，以及精液参数有显著改变的男性患者恶化的情况中相似。对于后一种情况的改善，临床医生认为必要的临界差值远高于其他临床情况。在理想的质量水平下，对于浓度和总活力，临床医生认为的变异系数低于基于生物学变异和现有技术的变异系数。然而，对于“a + b”级活力、“a”级活力、形态和活力而言，基于临床医生意见的变异系数高于基于生物学变异的变异系数，低于基于现有技术的变异系数。
基于临床医生意见的精液参数质量规范在很大程度上取决于临床情况和所分析的精液参数。
