两种免疫分析系统对乙型肝炎表面抗原定量测定的比较  

Comparative analysis of electro-chemiluminescence immunoassay and chemiluminescent microparticle immunoassay abilities to quantitatively assess hepatitis B surface antigen

作　　者：王洁 汪茂荣 

机构地区：[1]解放军第八一医院全军肝病中心,南京210002

出　　处：《中华肝脏病杂志》2013年第3期192-195,共4页Chinese Journal of Hepatology

摘　　要：目的对同一临床实验室的不同免疫自动检测系统进行评估，探讨不同检测系统间HBsAg定量测定结果是否具有可比性。方法采用电化学发光免疫分析法（ECLIA）和化学发光微粒子免疫分析法（CMIA）对100例HBV感染患者血清样本中的HBsAg分别进行定量检测，计量资料比较用x。检验，用线性回归统计法分析两检测系统间的差异，判断其可比性。结果两检测系统间HBsAg测定结果相关性良好（r≥0．95），在低值、中值和高值均表现出良好的相关性（r值分别为0．966、0．974和0．984）。两种检测系统的一致性为940／0，检测结果差异无统计学意义护〉0．05）。但HBsAg含量在0．10IU／ml附近时，两种检测系统检测结果有所不同。结论ECLIA与CMIA免疫分析系统在HBsAg定量检测中有较好的相关性，但在检测灵敏度上存在一定差异。Objective To perform a systematic comparative analysis of two different commercial automated systems using chemiluminescence immtmoassay to quantitatively detect hepatitis B virus surface antigen （HBsAg） in patient sera. Methods The Elecsys2010 electrical chemiluminescence immunoassay （ECLIA; manufactured by Roche） and the ARCHITECT il000 chemiluminescence magnetic microparticle immunoassay （CMIA; manufactured by Abbott） were used to detect HBsAg in 100 serum samples of individuals who presented at our department with suspected hepatitis infection between January and May 2012. The manufacturer＇s protocols were strictly followed. The categorical data was analyzed by Chi-squared test, and linear regression analysis was used to compare the results of the two assay systems. Results The HBsAg detection results from the two different assay systems showed good correlation （1- i〉 0.95）, and had good correlation at a low （r = 0.966）, medium （1- = 0.974） and high （r = 0.984） cutoff values. However, the positive detection rate of CMIA was significantly higher than that of ECLIA（94% vs. 88%, P 〈 0.05）. When the HBsAg content was below 0.10 IU/ml, the ECLIA detection rate and sensitivity were slightly higher than those of CMIA. Conclusion The ARCHITECT il000 and Elecsys 2010 immunoassay systems have good correlation in quantitative detection of HBsAg, but the former may be more sensitive.

关 键 词：肝炎表面抗原 乙型 诊断 电化学发光免疫分析法 化学发光微粒子免疫分析法 

分 类 号：R446.6[医药卫生—诊断学]