一种国产丙肝抗体检测试剂在血液筛查中的应用评价  

Evaluation of the application of a domestic HCV ELISA assay in blood screening

作　　者：范加诚[1] 华玉娟[1] 苏涛[1] 范风涛[1] 

机构地区：[1]泰安市红十字会中心血站,山东泰安271000

出　　处：《临床医药文献电子杂志》2017年第42期8252-8253,共2页Electronic Journal of Clinical Medical Literature

基　　金：泰安市科技发展基金项目(项目编号:2015NS1125)

摘　　要：目的通过与核酸检测(NAT)以及一种基于间接法免疫检测原理的酶联免疫吸附法(ELISA)试剂相比较,评估另一种基于双抗原夹心法免疫检测原理的ELISA试剂在献血者丙肝检测方面的表现。方法用NAT和两种免疫检测原理的ELISA试剂分别对39976份无偿献血者血样进行平行检测,并采用丙肝病毒抗体重组免疫印迹(HCV RIBA)试剂进行补充实验,分析比较结果。结果在检测HCV Ab上,夹心法原理ELISA试剂特异性优于间接法原理ELISA试剂,差异有统计学意义(P<0.05),前者与NAT比较,差异有统计学意义(P<0.01)。结论夹心法原理ELISA试剂与NAT结合应用于献血者丙肝病毒筛查,可以有效减少漏检和降低由假反应性造成的血液报废。Objective To evaluate the differences of domestic reagent that is Sandwich enzyme-linked immunosorbent assay （ELISA） in hepatitis C blood screening by comparing using Indirect ELISA and nucleic acids （NAT） detection.Methods A total of 39976 donor samples were tested for HCV detection through parallel detection by Sandwich ELISA,Indirect ELISA and NAT.The HCV reactive samples were confirmed by recombinant immunoblot assay （RIBA）.Analysis and comparison were conducted on all results. Results The specificity of Sandwich ELISA reagent was higher than Indirect ELISA reagent （P〈0.05）.And there was difference between Sandwich ELISA reagent and NAT （P〈0.01）.Conelusion Using both domestic Sandwich ELISA reagent and NAT together for detection of hepatitis C,that can effectively reduce the number of undetected blood samples and avoid false reactive.

关 键 词：双抗原夹心法 HCV ELISA NAT 血液筛查 

分 类 号：R446.6[医药卫生—诊断学]