精液分析中精子浓度室内质量控制方法的研究  

Internal quality control of sperm concentrations in semen analysis:Establishment of a method

作　　者：高选[1] 刘晓丹[1] 赵丽娟[1] 卢少明[1] 郑大伟[1] 马金龙[1] 

机构地区：[1]国家辅助生殖与优生工程技术研究中心,生殖内分泌教育部重点实验室,山东大学附属省立医院生殖中心,山东济南250021

出　　处：《中华男科学杂志》2012年第3期235-238,共4页National Journal of Andrology

摘　　要：目的:建立一种可行的精子浓度检测的室内质控方法。方法:设定20×106和80×106两种浓度的冷冻精液作为高、低值室内质控品(IQC),QC-BEADSTM质控珠(以下简称质控珠)作为对照。采用双盲法,4名技术员分别通过计算机辅助精液分析(CASA)对上述假定的室内质控品及质控珠进行精子浓度的测定,绘制出各自的质控图(Xbar图和Sbar图),连续检测1个月,计算出相应的高、低浓度值批内及批间变异系数(CV%),并进行比较。结果:①假定室内质控品高、低值批内变异系数分别CV3.5%,CV2.4%;批间分别为CV10.2%、CV9.6%。质控珠高、低值批内分别为CV5.1%,CV7.1%,批间分别CV7.1%,CV8.2%。两组高、低值的批内变异均<10%,批间变异均<15%,符合(Levey-Jennings)L-J质量控制原则,均能达到室内质控目的。②两组间高、低值的批内变异系数及批间变异系数无显著性差异(P>0.05),提示假定质控品可代替质控珠行实验室内部质量控制。结论:我们建立的精子浓度测定的室内质控方法是简单、易行、可靠。Objective ： To establish a method for internal quality control （IQC） of sperm concentration test in the laboratory. Methods： We set the concentrations of frozen semen at 20 ×10^6 and 80 ×10^6 as low and high concentrations of putative IQC products, with QC-BEADSTM quality control beads （ QCBs ） as the control. Using the double-blind method, four technicians determined the sperm concentrations of the IQC products and QCBs by computer-assisted sperm analysis, and drew a quality control chart （ Xbar chart and Sbar chart） for each product. Through a month of continuous detection, we calculated and compared the intra- and inter-batch co- efficients of variation （ CV% ） of the quality control products of high and low concentrations. Results ： The intra-batch coefficients of variation of the assumed IQC products of high and low concentrations were CV3.5% and CV2.4%, and their inter-batch coefficients of variation were CVI0.2% and CV9.6%. The intra-batch coefficients of variation of the QCBs of high and low concentrations were CV5. 1% and CV7.1%, and their inter-batch coefficients of variation were CV7.1% and CV8%. The intra-batch coefficients of variation of both IQC products and QCBs of high and low concentrations were 〈 10% , and their inter-batch coefficients of variation were 〈 15%, which conformed to Levey-Jennings quality control principles and achieved IQC purposes. No significant differences were found in either intra- or inter-batch coefficients of variation between the IQC products and QCBs of high and low concentrations （ P 〉 0.05 ）, indicating that assumed IQC products can replace QCBs for internal quality control in the laboratory. Conclusion： The IQC method we established for determining sperm concentration is simple, feasible and reliable. Natl J Androl, 2012, 18 （3） ： 233 -238

关 键 词：精液分析 精子浓度 质量控制 

分 类 号：R446.19[医药卫生—诊断学]