摘要：目的  建立人巨细胞病毒IgG抗体（HCMV IgG）时间分辨荧光免疫法（TrFIA）并研制其试剂盒。方法  采用HCMV pp150+pp52+pp65抗原作为包被抗原，铕标记羊抗人IgG作为示踪物，配制以β-萘甲酰三氟丙酮为主的增强液，应用间接TrFIA法测定HCMV IgG，将自制试剂盒与同类试剂盒进行方法学比对试验，比对定量结果的等效性采用线性回归分析。结果  自制试剂盒的最低检测限、重复性、阴性参考品符合率、阳性参考品符合率均能达到国家检定标准；检测标化的企业校准品，其实测值与理论值相对偏差均在±20.0%以内；在2.0 RU/mL～256.0 RU/mL范围内，线性相关系数不低于0.9900；于37℃恒温箱放置6天后，检测性能无明显改变；临床研究评价一致程度百分比可达99.4%，1020例临床样本定量结果的线性回归方程为Y=0.9594X+0.3252，r = 0.9918。结论  自制试剂盒灵敏度高、特异性强、精密度好、准确度高、线性范围宽；与同类检测结果相关性好，能满足临床需要。

Abstract：Objective To establish time-resolved fluoroimmunoassay for IgG antibody of human cytomegalovirus（HCMV）. Methods The HCMV pp150+pp52+pp65 antiage was coated on microplates, the goat anti-human IgG was labeled by Europrum. The enhancement solution was β-naphthalene thrifluoroacetone. The 1020 samples were analyzed by self-made kits and commercial kits. Results The detection limit, repeatability, compliance rate of negative and positive national standard of self-made time-resolved fluoroimmunoassay kit was in line with national accreditation standards. The linear range of time-resolved fluoroimmunoassay was from 2.0 to 256.0 RU/mL, the linear correlation coefficient was up to 0.99. The analysis performance of kits had no significant changes after storing at 37℃ for six days. The testing results of self-made kit with reference kit for 1020 samples was linear correlation (Y = 0.9594X +0.3252, r = 0.9918). Conclusion The time-resolved fluoroimmunoassay for IgG antibody of human cytomegalovirus established in this study and self-made kit have high sensitivity, specificity, good precision and high accuracy. It could meet clinical demand for the analysis of IgG antibody of human cytomegalovirus.