五种国产酶免疫测定法抗乙型肝炎病毒核心抗原抗体检测试剂的评价  

Evaluation of 5 Kinds of China-made Enzyme Immuoassay Kits for Antibody to Hepatitis B Virus Core Antigen Detection

作　　者：马景臣[1] 齐倾祥[1] 王锋[2] 余陶[2] 张文英[2] 赵守军 张勇[2] 

机构地区：[1]河北省疾病预防控制中心,石家庄050021 [2]中国疾病预防控制中心病毒病预防控制所,传染病预防控制国家重点实验室,北京100052 [3]Department of Radiology,University of California,San Francisco 94143,USA

出　　处：《中国疫苗和免疫》2009年第5期400-403,共4页Chinese Journal of Vaccines and Immunization

基　　金：卫生部全国乙型病毒性肝炎血清流行病学调查专项资金

摘　　要：目的为全国人群乙型病毒性肝炎(乙肝)血清流行病学调查,筛选适宜的抗乙肝病毒核心抗原抗体(Antibody to Hepatitis B Virus Core Antigen,Anti-HBc)检测试剂。方法选择符合国家质量标准,且在全国销量最大的五种(A、B、C、D、E)酶免疫测定法Anti-HBc检测试剂,平行检测由95份阳性和57份阴性参比品组成的参比系统各5次,将每个检测的co/s值(诊断试验截断值与样品速率值之比)做log(co/s+1)转换,计算并比较各试剂的可靠性指标组内相关系数(Intraclass Correlation Coefficient,ICC)、变异系数(Coefficient of Variability,CV)和真实性指标曲线下面积(Area Under Curve,AUC)、部分(partial)AUC(pAUC)、固定特异度下的灵敏度[Se(FPR=e)]等。结果五种试剂ICC、CV从优到劣的排序均为A、B、D、C、E,除ICC指标试剂B与D外,试剂间差异有统计学意义(Bootstrap法,P<0.05);五种试剂的AUC在0.991～0.997,pAUC最大的试剂B、C、D间的差异无统计学意义,但同时明显大于试剂A、E(Bootstrap法,P<0.05);Se(FPR=e)指标只有最高的试剂B明显高于最低的试剂A、E,但与试剂C、D间的差异无统计学意义。结论五种试剂按优劣依次为B、C、D、A、E。Objective To Screen an EIA kit that fits best for using in serological detection of anti-HBc in the national investigation of hepatitis B virus infection. Methods Top 5 kinds of kits on the best seller list of China-made anti-HBc EIA kit were selected and each detect the anti-HBc panel （95 positive and 57 negative） 5 times. The co/s ratio of each test was recorded and transformed by lg（co/s＋1）. Reliability indices ICC and CV, and validity indices AUC, pAUC and Se（FPR=e） were calculated and compared between each kit. Results The indices of ICC and CV of the 5 kinds of kits arranged in the same order of A, B, D, C and E, from the best to the worst. And the differences between them were significantly important （Bootstrap method, P 〈0.05）,except for between kits B and D in CV index; The AUCs ranged from 0.991 to 0.997; For index pAUCs, differences were significant between kits B, D, C ,which had the biggest values, kits A and E which had the lowest ones. For index Se（FPR=e）, significant differences were only seen between kits B and A, and B and E （Bootstrap method, P〈0.05）. Conelusion The diagnostic ability of all the 5 kinds of kits arrange in an order of B, C, D, A and E, from the best to the worst.

关 键 词：诊断试验 抗乙型肝炎病毒核心抗原抗体 评价 受试者工作特征曲线 

分 类 号：R373.2[医药卫生—病原生物学]