精液分析的外部质量控制研究

摘要

目的 在严格遵循WHO第5版精液分析标准化方法培训的基础上,率先在国内男科学实验室尝试开展外部质量控制,探索精液分析外部质量控制的方法和模式,为在全国范围内开展精液分析的外部质量控制打下基础. 方法 本实验室根据《世界卫生组织人类精液检查与处理实验室手册》第5版(WHO5)推荐的标准化精液分析方法,对来自全国23个实验室的技术人员进行理论与实际操作培训.各实验室技术人员带回质控样本,包括冷冻的混合精液、伊红-苯胺黑染色并封片的玻片、未经染色固定的形态学涂片,分别作为精子浓度、精子存活率和精子形态学评估的质控品.各实验室按要求采用血球计数板方法评估精子浓度；×100倍油镜评估精子存活率；巴氏染色法染色质控片并用×100倍油镜评估精子正常形态率；在规定日期内反馈结果.用WHO5推荐方法对外部质控结果进行评估. 结果 于截止日期前21个实验室反馈了结果.对2个质控品进行精子浓度评估,各实验室间的变异系数(CV)分别为28.54％和27.11％.Youden图分析,15％实验室的2个质控品的检测结果均在95％可信区间内.对2个质控品进行精子存活率评估,各实验室间的CV分别为7.90％和9.59％.Youden图分析,42％的实验室2个质控品检测结果均在95％可信区间内.对2个质控品进行精子正常形态率评估,各实验室间的CV为52.96％和48.66％.Youden图分析,14％的实验室2个质控品检测结果均在95％可信区间内.结论 结果表明,严格遵循WHO5精液分析标准化方法培训后,除精子存活率评估各实验室间的CV较低、在控的实验室较多外,精子浓度评估和形态学分析CV均较高、失控的实验室较多.精液分析的质量亟需提高、标准化培训亟待普及和推广,质量控制迫在眉睫.%Objective: To explore the methods and patterns of external quality control(EQC)program on semen analysis in China.Methods: Technicians from 23 laboratories in China attended a training workshop organized by our coordinating center laboratory according to the standardized laboratory protocols of WHO laboratory manual for the examination and processing of human semen (fifth edition) (WH05). The quality control materials including two aliquots of frozen pooled semen sample for sperm concentration, Eosin Y-nigrosin smears for sperm vitality and unstained smears for sperm morphology were carried by the trainee to their home laboratory after the training program. Each laboratory was required to assess sperm concentration, vitality and morphology with scheduled protocols. The results were required to feedback within stipulateddate. The EQC results were evaluated according to the methods recommended by WH05.Results: Twenty-one of 23 laboratories returned their results to coordinating center laboratory in deadline. For sperm concentration, the coefficients of variation (CV) of 2 quality control (QC) samples among 21 laboratories were 28. 54% and 27. 11%, respectively. The results of both QC samples from 15 % laboratories were inside the 95% confidence interval by Youden plot. For sperm vitality, the CVs of 2 QC samples among 21 laboratories were 7. 90% and 9. 59%, respectively. The results of 2 QC samples from 42% laboratories were both inside the 95% confidence interval by Youden plot. For sperm morphology, the CVs of 2 QC samples among 21 laboratories were 52. 96% and 48. 66%, respectively. The results of 2 QC samples from 14% laboratories were both inside the 95% confidence interval by Youden plot.Conclusions; From our results, the CV of sperm vitality assessment among the laboratories was lower than those of the other two parameters assessed, and the results from the most laboratories were in control. The CVs of sperm concentration and morphology assessment among the laboratories were higher and the most laboratories' results were out of control limits. It indicated that the quality control of semen analysis is desiderated to be improved, and standardized training on semen analysis is urgently need.