摘要:目的通过初步建 立湖南省精液常规检验室间质量评价(质评)体系，了解湖南地区不同生殖男科实验室精液常规检验结果的差异,从而提高湖南地区整体精液常规检验水平。方法分 2次制备并发放2个不同水平的精子浓度及精子活力质控 品,发放给湖南地区20家生殖男科实验室，回收检验结果并采用Robust稳健统计法及实验室能力比对分析(PT)评价实验室的检验能力。结果70%( 14/20)的实验室采用计算机辅助精子分析(CASA).30% ( 6/20)使用Makler 计数板手工计数分析 精子浓度;50%( 10/20)的实验室采用CASA、50%( 10/20)采用手工方式分析精子活力。4个精子浓度质控品的实验室间变异系数(CV)范围为13.47%~21.79% ;4个活力质控品CV范围，前向运动精子率(PR)为5.65%~ 20.76%,非前向运动精子率. (NP)为31.36% ~ 59.30% ,不活动精子率(IM)为5.50%~8.80%。 20家参评实验室精子浓度项目评价结果显示, 65%( 13/20)合格,10%(2/20)可疑,25%(5/20)离群;20家参评实验室精子活力项目评价结果显示，30%(6/20)合格,35% (7/20)可疑， 30%(6/20)离群,1家5%( 1/20)未回报第一次活力结果。PT合格率(PT≥80%)为55%(11/20),不合格率(PT<80%)为45%(9/20)。结论通过 Robust稳健统计法评价生殖男科实验室的精液常规检验能力可行;亟需对实验室技术人员进行标准化培训和质量控制,以提高湖南地区各生殖男科实验室精液常规分析水平。
Abstract: Objective To investigate the differences in the results of routine semen testing from diferent reproductive and andrology laboratories in Hunan province by establishing preliminarily an inter-l aboratory quality assessment ( QA) system for routine semen testing in Hunan province, and then improve the overall level of routine semen testing in Hunan province. Methods Two diferent levels of sperm concentration and sperm motility video quality control materials were prepared in two batches and distributed to 20 reproductive and andrology laboratories in Hunan province. Then, the testing results were collcted and analyzed by the Robust statistics method,and the testing ability of a laboratory was evaluated by the laboratory proficiency testing ( PT) analysis. Results 70% ( 14/20) of la- boratories determined spermn concentration by a computer- assisted sperm analysis ( CASA) system, and 30% ( 6/20) of laboratories by the manual method with a Makler chamber. 50% ( 10/20) of laboratories analyzed sperm motility by a CASA system, and 50% ( 10/20) of laboratories by the manual method. The inter-laboratory coefficients of variation ( CV) of four sperm concentration quality control samples ranged from 13.47% to 21.79%. The inter-laboratory CVs of progressive motility ( PR)，non-progressive motility ( NP)and immotile sperm rate ( IM) of four sperm motility quality control samples were 5.65% - 20.76%，31.36% - 59.30% and 5.50% -8.80%，respectively. The evaluation results of sperm concentration items in 20 participating laboratories showed that 65% ( 13/20)were qualified, 10% ( 2/20) were suspicious, and 25% (5/20) were outliers. The evaluation results of sperm motility items in 20 participating laboratories showed that 30% (6/20) were qualified, 35% (7/20) were suspicious, 30% ( 6/20) were outlier, and 5%( 1/20) did not report their first sperm motility results. The qualification rate of PT (PT≥80%) was 55% (11/20)，and the unqualification rate ( PT<80%) was 45% (9/20). Conclusion It is feasible to evaluate the testing ability of routine semen testing in repro-ductive and andrology laboratories by the Robust statistics method. It is urgently needed to perform standardized training and quality control for laboratory technicians and improve the level of routine semen analysis of reproductive and andrology laboratories in H unanprovince.