Gao Xuan, Liu Xiao-Dan, Zhao Li-Juan, Lu Shao-Ming, Zheng Da-Wei, Ma Jin-Long
National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Key Laboratory for Reproductive Endocrinology of the Chinese Ministry of Education, Center for Reproductive Medicine, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China.
Zhonghua Nan Ke Xue. 2012 Mar;18(3):235-8.
To establish a method for internal quality control (IQC) of sperm concentration test in the laboratory.
We set the concentrations of frozen semen at 20 x 10(6) and 80 x 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 coefficients of variation (CV%) of the quality control products of high and low concentrations.
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 CV10.2% 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.
The IQC method we established for determining sperm concentration is simple, feasible and reliable.
建立实验室精子浓度检测的室内质量控制（IQC）方法。
将冷冻精液浓度设定为20×10⁶和80×10⁶作为假定IQC产品的低浓度和高浓度，以QC - BEADSTM质量控制微珠（QCBs）作为对照。采用双盲法，4名技术人员通过计算机辅助精子分析测定IQC产品和QCBs的精子浓度，并为每个产品绘制质量控制图（均值极差控制图和标准差控制图）。通过连续1个月的检测，计算并比较高、低浓度质量控制产品的批内和批间变异系数（CV%）。
高、低浓度假定IQC产品的批内变异系数分别为CV3.5%和CV2.4%，批间变异系数分别为CV10.2%和CV9.6%。高、低浓度QCBs的批内变异系数分别为CV5.1%和CV7.1%，批间变异系数分别为CV7.1%和CV8%。高、低浓度IQC产品和QCBs的批内变异系数均<10%，批间变异系数均<15%，符合Levey - Jennings质量控制原则，达到了IQC目的。高、低浓度IQC产品与QCBs的批内和批间变异系数均无显著差异（P>0.05），表明假定IQC产品可替代QCBs用于实验室室内质量控制。
我们建立的测定精子浓度的IQC方法简单、可行且可靠。
