三种丙型肝炎病毒核心抗原检测方法初步比较  

Preliminary comparison between 3 Hepatitis C Virus core antigen detection methods

作　　者：王美玉[1] 裴丽健[1] 于海英[1] 蒋岩[1] 陈兵[1] 吕铭洋[1] 邢文革[1] 

机构地区：[1]中国疾病预防控制中心性病艾滋病预防控制中心国家参比实验室,北京102206

出　　处：《中国艾滋病性病》2014年第5期364-366,共3页Chinese Journal of Aids & STD

基　　金：中美艾滋病防治合作项目~~

摘　　要：目的对三种丙型肝炎病毒核心抗原（HCV cAg）的检测试剂进行初步比较。方法对72份抗体检测阳性样本进行HCV核糖核酸（RNA）、HCV核心抗原检测,其中HCV cAg分别采用A、B、C 3种试剂平行检测,实验室检测和数据统计均采用盲法。结果 A、B、C 3种HCV cAg检测试剂与核酸检测的符合率分别为97.22%、72.22%、54.16%,两两之间差异均有统计学意义（P〈0.05）。试剂A对HCVcAg的检出率与HCV RNA的检出率高度一致（Kappa=0.8421,95%可信区间：0.6290-1.0000）。方法B、C与核酸检测无一致性,差异有统计学意义（P〈0.05）。Cochran-Armitage趋势性检验表明,三种试剂对HCV cAg的检出率均随HCV RNA浓度升高而提高（Z统计量单侧P〈0.0001）。结论方法 A可作为条件有限时核酸检测的替代方法;三种HCV Ag检测方法的检测水平之间存在较大差距;三种方法对HCV cAg的检出能力均随核酸浓度的升高而增强。Objective To compare 3 HCV core antigen detection reagents. Methods HCV RNA and HCV core antigen （tAg） were detected in 72 anti-HCV antibody positive samples. HCV core antigen were parallelly detected by 3 kinds of HCV tAg detection reagents （A,B and C）. Blinded methods were adopted in sample detection and data analysis. Results The coincidence rates of the three methods （A,B and C） compared with the HCV RNA test were 97.22%, 72.22% and 54.16% ,respectively. Any two of the 3 coincidence rates showed significant differences （P d0.05）. The relevance ratio between kit A and ROCHE CAP/CTM HCV detection showed remarkably consistent （Kappa=0. 8421,95%CI：0. 6290-1. 0000）, while this consistency had not been shown in kit B or C with significant difference （P〈0.05）. Cochran-Armitage trend test showed that detection rates of the three reagents for HCV tAg increased with the increase of HCV RNA concentration （Z statistic, one sided P〈0. 0001）. Conclusion Kit A may be used as an alternative method of nucleic acid detection in resouce-limited settings. The detection level between the 3 reagents shows significant disparity. The ability of the 3 reagents for HCV eAg detection increase with the increase of concentration of HCV RNA.

关 键 词：丙型肝炎病毒 核心抗原 核酸 检测方法 

分 类 号：R378.2[医药卫生—病原生物学]