两种方法检测HBsAg定量结果的临床互认研究

doi:10.3969/j.issn.1673-8640.2013.09.023

检验医学 ›› 2013, Vol. 28 ›› Issue (9): 828-834.DOI: 10.3969/j.issn.1673-8640.2013.09.023

• 技术研究与评价.论著 • 上一篇下一篇

两种方法检测HBsAg定量结果的临床互认研究

盛欢^¹,胡晓波^¹,许洁^²

1.上海交通大学医学院附属第三人民医院检验科,上海 201900;
2.上海交通大学医学院附属第三人民医院感染科,上海 201900

收稿日期:2013-09-25 修回日期:2013-09-25 出版日期:2013-09-15 发布日期:2013-09-25
通讯作者: 胡晓波,联系电话:021-56691101。
作者简介:盛欢,女,1982年生,学士,技师,主要从事临床检验工作。

A clinical consensus study of HBsAg quantitative results by two methods

SHENG Huan^¹,HU Xiaobo^¹,XU Jie^²

1.Department of Clinical Laboratory,Shanghai Third People′s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 201900,China;
2.Department of Infection, Shanghai Third People′s Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 201900, China

Received:2013-09-25 Revised:2013-09-25 Online:2013-09-15 Published:2013-09-25

摘要/Abstract

摘要：

目的评估罗氏和雅培公司乙型肝炎表面抗原(HBsAg)定量检测临床应用可行性。方法收集423例血清和血浆标本,用雅培公司ARCHITECT HBsAg试剂和罗氏公司HBsAg quantitative Elecsys试剂进行比较检测,采用统计学方法分析两者之间的关系,并对2种试剂进行性能评估。结果定量试剂的分析内和分析间变异系数(CV)较小。同一患者血清和血浆HBsAg结果相关性较好(r＝0.988,P<0.05),罗氏与雅培试剂在检测HBsAg结果的相关性较好(r=0.965,P<0.05)。2种试剂对脂血、黄疸、溶血等可疑干扰物抗干扰能力相同。2种试剂的检测限均为0.05 IU/mL。2种试剂通过稀释,都可报告常见的高值HBsAg检测结果。2种试剂回收率性能一致。结论 2种HBsAg定量检测试剂在检测结果方面符合性较高,具有良好的相关性,其HBsAg检测结果可以互认。

关键词: 乙型肝炎表面抗原, 相关性, 结果互认

Abstract:

Objective To evaluate the clinical application feasibility of hepatitis B surface antigen (HBsAg) quantitative determination by Roche and Abbott. Methods A total of 423 serum and plasma samples were collected and determined by Abbott ARCHITECT HBsAg and Roche HBsAg quantitative Elecsys, and the results were analyzed comparatively. The correlation was analyzed statistically. Performance evaluation on Roche and Abbott was also conducted. Results The intra-analysis and inter-analysis coefficients of variation (CV) were low. The HBsAg results of serum and plasma samples from the same patient correlated well (r=0.988, P<0.05). The correlation between Roche and Abbott was good (r=0.965,P<0.05). The 2 assays were not influenced by potential interferences such as lipemia, icterus and hemolysis. The limit of the 2 assays was 0.05 IU/mL. Through dilution, the 2 assays could report the common clinical high-value HBsAg results. The recoveries of the 2 assays were consistent. Conclusions Results from Roche and Abbott HBsAg quantitative results are consistent and have a good correlation, and they are suitable for the clinical application. HBsAg results are consensus for each other.

Key words: Hepatitis B surface antigen, Correlation, Result consensus

中图分类号:

R446.61

盛欢,胡晓波,许洁. 两种方法检测HBsAg定量结果的临床互认研究[J]. 检验医学, 2013, 28(9): 828-834.

SHENG Huan,HU Xiaobo,XU Jie. A clinical consensus study of HBsAg quantitative results by two methods[J]. , 2013, 28(9): 828-834.

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两种方法检测HBsAg定量结果的临床互认研究

A clinical consensus study of HBsAg quantitative results by two methods

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