机构地区:[1]广东省韶关市粤北人民医院,广东韶关512025
出 处:《中国医学创新》2020年第13期143-148,共6页Medical Innovation of China
基 金:韶关市卫生计生科研项目(Y18027)。
摘 要:目的:探索一种可行的男科实验室计算机辅助精液分析系统(Computer-aided Semen Analysis System,CASA)的质控方法。方法:参考第5版《世界卫生组织人类精液分析实验室技术手册》推荐的分析方法和质控标准,分别使用高、低浓度的自制精液质控品和商品化质控珠对CASA的检测结果进行一致性分析。同时由两名实验员使用CASA对18份精液样本的浓度和活力进行双盲分析,并绘制Bland-Altman图对检测结果进行比较分析。结果:自制精液质控品高、低浓度批内变异系数分别为CV4.0%、CV5.8%,质控珠高、低浓度批内分变异系数分别为CV7.8%、CV7.6%,均符合Levey-Jennings质控规则。Youden分析显示两种质控品的检测结果均位于95%CI。Bland-Altman图分析显示,两名实验员对18份精液标本的浓度和活力检测结果差值的绝对值均位于95%CI内,检测结果一致性高。结论:CASA需要适当的质控方案保证其分析结果的准确性,本研究中无论是自制的精液质控品还是商品化质控珠,均能在CASA的精液浓度质控中起到良好的效果。在精子活力分析质控方面,CASA比传统的人工分析方法能够更加准确捕捉精子运动轨迹并提供更多精子运动信息。男科实验室的CASA质量控制不仅需要严格执行室内质控,还需要通过室间质评进一步保证仪器检测结果的准确性。Objective: To explore a feasible method for quality control of computer-aided semen analysis(CASA) in the andrology laboratory. Method: With reference to the analytical methods and standards recommended in the 5th edition of WHO Laboratory Manual for the Examination and Processing of Human Semen, the consistency analysis of CASA system was conducted by using high and low concentrations of self-made semen quality control samples and commercial quality control beads. At the same time, the concentration and motility of 18 different semen samples were double-blind analyzed by two experimenters using CASA system, then the bland-altman graphs was drawn to compare the test results. Result: The variation coefficients of high and low concentration self-made semen quality control samples were CV4.0% and CV5.8%, respectively. The intra-batch variation coefficients of high and low concentration control beads were CV7.8% and CV7.6%, respectively. All the statistical results were conformed with the quality control principle of Levey-Jennings. Youden analysis showed that the detection results of the two germplasm controls were at 95%CI. Bland-altman graphs showed that the absolute value of the difference between the concentration and activity of 18 semen samples tested by two experimenters was within the 95%CI, and the consistency was high. Conclusion: The CASA system needs an appropriate quality control method to ensure the accuracy of the analysis results. In this study, both self-made semen quality control samples and commercial quality control beads can take effect in the semen concentration quality control of CASA. In the quality control of sperm motility analysis, CASA is more accurate than the traditional manual analysis method in capturing sperm motility track and providing more sperm motility information. The quality control of CASA in andrology laboratory not only needs to strictly implement the indoor quality control, but also needs to further ensure the accuracy of the instrument test results through the indoor qual
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