电化学发光免疫法定量测定乙肝表面抗原的性能评价

目的：评价罗氏Elecsys电化学发光免疫法定量测定血清乙肝表面抗原（HBsAg）的分析性能及血清HBsAg定量水平与乙肝e抗原、乙肝病毒载量之间的关系。方法：使用质控品和病人血清样品分析Elecsys系统测定HBsAg的最低检测限、精密度、线性范围;收集361例乙肝患者血清样本运用本法及雅培Architect系统作对比测定,并结合患者乙肝e抗原和乙肝病毒DNA测定结果作比较分析。结果：本法最低检测限为0.03 IU·ml-1;批内CV分别为3.6%、2.9%和3.4%;批间CV分别为4.3%、4.6%和4.1%;线性范围为0~130 IU·ml-1和20~52 000 IU·ml-1（1∶400稀释）;罗氏Elecsys与雅培Architect系统测定HBsAg结果 （Log10 IU·ml-1）的线性关系：y=1.04x-0.13,r=0.963。乙肝患者血液HBsAg水平与e抗原、乙肝病毒载量之间的相关关系分别是r=0.443,P=0.01和r=0.629,P=0.01。结论：罗氏Elecsys系统分析性能满足临床需求,该系统测定HBsAg与雅培Architect系统测定结果有高度相关性。乙肝患者血液HBsAg定量水平与e抗原、乙肝病毒载量之间呈正相关关系,是反映乙肝患者抗病毒治疗效果的重要指标。

The applicable evaluation of the quantitative determination of hepatitis B surface antigen with the electrochemiluminescence immunoassay

Objective： To evaluate the analytical performance on the quantitative determination of HBsAg with Roche Elecsys and the relationships between the results of HBsAg with serum HBeAg and HBV-DNA levels. Methods： The lower limit of detection,precision and linear range were performed with the controls and patient serum samples. 361 samples from chronic hepatitis B（ CHB） patients were collected and HBsAg levels were detected by Roche Elecsys and Architect system. The relationships among HBsAg levels and HBeAg,HBV-DNA quantitation were investigated. Results： The lower limit of detection（ LLD） was 0. 03 IU·ml-1. The coefficient variations（ CVs） of within day were 3. 6%,2. 9%,3. 4%; the CVs of between-day were 4. 3%,4. 6%,4. 1%; the linear range was 0 ~ 130 IU·ml-1or 20 ~ 52 000 IU·ml-1（ 1∶ 400 dilution）. The quantitative results of HBsAg measured by Roche Elecsys showed good linear correlation with those by Architect system： y = 1. 04x-0. 13,r = 0. 963. The positive correlation were observed among the levels of HBsAg,HbeAg and the load of HBV-DNA,r = 0. 443,P = 0. 01 and r = 0. 629,P = 0. 01. Conclusion： Serum HBsAg Level was positively correlated with e antigen and HBV-DNA concentrations,it can reflect HBV replicative status and the efficacy of antiviral treatment. High correlation was found between quantitative HBsAg measurements conducted with the Elecsys and the Architect system and the Elecsys system can satisfy the requirement of clinic.