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意大利托斯卡纳地区男科实验室精液分析结果的高度变异性:外部质量控制(EQC)计划的经验。

High variability in results of semen analysis in andrology laboratories in Tuscany (Italy): the experience of an external quality control (EQC) programme.

机构信息

Department of Clinical Physiopathology, Sexual Medicine and Andrology Unit, Florence, Italy.

出版信息

Andrology. 2013 May;1(3):401-7. doi: 10.1111/j.2047-2927.2012.00042.x. Epub 2013 Jan 11.

DOI:10.1111/j.2047-2927.2012.00042.x
PMID:23307477
Abstract

We report the results of the first three trials of an external quality control (EQC) programme performed in 71 laboratories executing semen analysis in Tuscany Region (Italy). At the end of the second trial, participants were invited to attend a teaching course illustrating and inviting to adhere to procedures recommended by WHO (V edition). Results of the first three trials of the EQC documented a huge variability in the procedures and the results. The highest variability was found for morphology (CV above 80% for all the trials), followed by count (CV of about 60% for all the trials) and motility (CV below 30% for all the trials). When results of sperm count and morphology were divided according to the used method, mean CV values did not show significant differences. CV for morphology dropped significantly at the third trial for most methods, indicating the usefulness of the teaching course for morphology assessment. Conversely, no differences were observed after the course for motility and for most methods to evaluate count, although CV values were lower at the second and third trial for the laboratories using the Burker cytometer. When results were divided according to tertiles of activity, the lowest mean bias values (difference between each laboratory result and the median value of the results) for count and morphology were observed for laboratories in the third tertile (performing over 200 semen analysis/year). Of interest, mean bias values for concentration dropped significantly at the third trial for low activity laboratories. In conclusion, lack of agreement of results of semen analysis in Tuscany is mainly because of the activity and the experience of the laboratory. Our study points out the importance of participating in EQC programmes and periodical teaching courses as well as the use of WHO recommended standardized procedures to increase precision and to allow the use of WHO reference values.

摘要

我们报告了在意大利托斯卡纳地区(意大利)的 71 个实验室执行精液分析的首次三个外部质量控制(EQC)计划试验的结果。在第二次试验结束时,邀请参与者参加一个教学课程,介绍并邀请他们遵守世界卫生组织(第五版)推荐的程序。EQC 的前三个试验的结果记录了程序和结果的巨大差异。形态学的变异性最大(所有试验的 CV 均高于 80%),其次是计数(所有试验的 CV 约为 60%)和活力(所有试验的 CV 均低于 30%)。当根据使用的方法对精子计数和形态学结果进行划分时,平均 CV 值没有显示出显著差异。对于大多数方法,形态学的 CV 在第三次试验中显着下降,表明该教学课程对形态学评估有用。相反,在课程之后,对于大多数评估活力和计数的方法,没有观察到差异,尽管使用 Burkker 细胞计数器的实验室在第二次和第三次试验中 CV 值较低。当根据活性的三分位数对结果进行划分时,对于每年进行超过 200 次精液分析的第三三分位实验室,计数和形态学的最低平均偏差值(每个实验室结果与结果中位数之间的差异)。有趣的是,对于低活性实验室,浓度的平均偏差值在第三次试验中显着下降。总之,托斯卡纳地区精液分析结果缺乏一致性主要是由于实验室的活动和经验。我们的研究指出了参与 EQC 计划和定期教学课程以及使用世界卫生组织推荐的标准化程序的重要性,以提高精度并允许使用世界卫生组织参考值。

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