目的　验证细胞病变抑制法检测血浆和静注巨细胞病毒人免疫球蛋白（pH4）（human cytomegalovirus immunoglobulin for intravenous injection，CMV-IVIG）的巨细胞病毒中和抗体（human cytomegalovirus neutralizing antibody， CMV-NA）效价的适用性。方法　采用巨细胞病毒人免疫球蛋白国家标准品建立CMV-NA效价检测细胞病变抑制法。采用CMV-NA 血浆和CMV-IVIG验证细胞病变抑制法的重复性、中间精密度、专属性、准确性、耐用性、重现性。结果　血浆和CMV-IVIG的CMV-NA效价重复性验证的相对标准偏差分别为12%和19%。2名实验人员重复检测6次血浆和CMV-IVIG的CMV-NA效价，其F值分别为0.84和0.03，P值均＞0.05。不同日期下重复检测6次血浆和CMV-IVIG的CMV-NA效价，其F值分别为0.89和0.55，P值均＞0.05。血浆、CMV-IVIG和国家标准品溶液的细胞均无病变。血浆和CMV-IVIG加标样品的回收率均在100%±40%之间。采用不同中和时间检测血浆和CMV-IVIG的CMV-NA效价，F值分别为0.48和0.04，P值均＞0.05。采用不同病毒滴度范围检测血浆和CMV-IVIG的CMV-NA效价，F值分别为0.49和0.11，P值均＞0.05。2个实验室检测CMV-IVIG的CMV-NA效价，t值为0.69， P值＞0.05。结论　细胞病变抑制法检测CMV-NA效价具有良好的重复性、中间精密度、专属性、准确性、耐用性和重现性。

Objective　To investigate the applicability of cytopathic inhibition assay for the detection of human cytomegalovirus neutralizing antibody (CMV-NA) potency in plasma and human cytomegalovirus immunoglobulin for intravenous injection (CMV-IVIG).Methods　Cytopathic inhibition assay for detection of CMV-NA potency was established with cytomegalovirus immunoglobulin national standard substance. The repeatability, intermediate precision, specificity, accuracy, durability and reproducibility of cytopathic inhibition assay were investigated with CMV-NA plasma and CMV-IVIG.Results　The relative standard deviations of the repeatability validation of CMV-NA potency for plasma and CMV-IVIG were 12% and 19%, respectively. The CMV-NA potency of plasma and CMV-IVIG were detected 6 times by 2 experimentalists, with F values of 0.84 and 0.03, respectively, and P > 0.05. With 6 repetitions of plasma and CMV-IVIG for CMV-NA potency tested on different dates, the F values were 0.89 and 0.55, respectively, with P > 0.05. Plasma, CMV-IVIG and national standard substance were free of cytopathy. The recovery rates of both plasma and CMV-IVIG labeled samples were within 100% ± 40%. The CMV-NA potencies of plasma and CMV-IVIG were tested at various neutralization time, and the F values were 0.48 and 0.04, respectively, with P > 0.05. The CMV-NA potencies of plasma and CMV-IVIG were detected in different viral titer ranges with F values of 0.49 and 0.11, respectively, and P >0.05. The CMV-NA potency of CMV-IVIG was detected by 2 laboratories with a t value of 0.69 and P >0.05.Conclusion　The cytopathic inhibition assay for CMV-NA potency has good repeatability, intermediate precision, specificity, accuracy, durability and reproducibility.