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抗-HCV酶联免疫吸附试验试剂的评价
引用本文:杨芳,邢文革,于海英,蒋岩.抗-HCV酶联免疫吸附试验试剂的评价[J].中国输血杂志,2009,22(5).
作者姓名:杨芳  邢文革  于海英  蒋岩
作者单位:中国疾病预防控制中心国家艾滋病参比实验室,北京,100050
摘    要:目的评价国内外11种抗-HCV酶联免疫吸附试验(ELISA)试剂的质量。方法采用艾滋病参比实验室基础血清盘、BBI阳转血清盘、美国CAP特性血清盘,对国产和进口的试剂进行质量测评。评价指标包括敏感性、特异性、阳性预测值、阴性预测值等。结果11种抗-HCV ELISA检测试剂的敏感性均为100%,多数试剂特异性>90%。阳转血清盘评价显示5种试剂平均延长天数<2d,大多数试剂未检出抗-NS3。所有试剂均检测能出抗核心区抗体。美国CAP特性血清盘评价显示所有试剂检测结果与标准结果一致率均为100%。结论11种抗-HCV酶联免疫吸附试验试剂有较高的敏感性,特异性有差异。由于ELISA抗-HCV试剂敏感性高,实用性强,适合于我国一般人群的筛查检测。

关 键 词:抗-HCV  酶联免疫吸附试验(ELISA)  试剂评价

Evaluation of the anti-HCV enzyme-linked immunosorbent assay
YANG Fang,XING Wenge,YU Haiying,et al Chinese Center for Disease Control , Prevention,NCAIDS,Beijing ,China.Evaluation of the anti-HCV enzyme-linked immunosorbent assay[J].Chinese Journal of Blood Transfusion,2009,22(5).
Authors:YANG Fang  XING Wenge  YU Haiying  Chinese Center for Disease Control  Prevention  NCAIDS  Beijing  China
Institution:YANG Fang,XING Wenge,YU Haiying,et al Chinese Center for Disease Control , Prevention,NCAIDS,Beijing 100050,China
Abstract:Objective To evaluate 11 anti-HCV enzyme-linked immunosorbent assay reagent kits. Methods Eleven ELISA kits, including domestic and foreign ones, were evaluated by three serum panels including AIDS reference lab master panel, BBI serocoversion panel and CAP serum panel. Evaluation indexes contained sensitivity,specificity,positive predict value and negative predict value. Results Sensitivity in 11 kits was 100 percent, while specificity in most of them was larger than 90 percent. Based on serocoversion pane...
Keywords:HCV  Enzyme-linked immunosorbent assay  Kits evaluation  
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