目的 分析商品化试剂盒检测人乙型肝炎病毒(乙肝)表面抗体(抗-HBs)之间的差异。方法 本院实验标本252份,分别用雅培I2000定量试剂盒、罗氏e601定量试剂盒、安图Auto Lumo A2000定量检测试剂盒和国内主流酶联免疫法定性试剂盒(上海科华)检测人乙肝表面抗体,以假定金标准对各厂家的阴、阳性结果进行比对分析,并对3个定量检测系统进行量值相关性分析。结果 4种乙肝表面抗体试剂与假定金标准相比,灵敏度和特异性都达到了93%以上,其中安图和罗氏的灵敏度和特异性最高,达到了98%以上;罗氏试剂盒的跃登指数(灵敏度+特异性－100%)最高,为99.3%;与金标准比较,3种化学发光试剂盒检测结果无统计学差异(P>0.05),而酶联免疫法定性试剂盒检测结果有统计学差异(P<0.05)。结论 主流乙肝表面抗体试剂盒在检验乙肝表面抗体时均存在一定的假阳性或假阴性,量值相关性较好,不影响临床应用分析。
Abstract
Objective To study four commercially available assays for antibody to hepatitis B virus surface antigen. Methods A total of 252 specimens were tested by Abbott i2000、Roche e601、Autobio AutoLumoA2000 and a ELISA kit, respectively,and the quantitative results and the performance characteristics of the different test systems were compared. Results The sensitivity and specificity of different manufacturer kits for Anti-HBs were beyond 93%. The detection rates of compared CLIA(Chemiluminescence Immunoassay) commercial Anti-HBs reagents had no significant difference (P>0.05). Conclusions The four commercial Anti-HBs reagents have false positive and false negative results; the correlation analysis for quantitative results is beyond 0.85.
关键词
表面抗体 /
金标准 /
灵敏度 /
特异性 /
量值相关性
Key words
antibody to hepatitis B surface antigen /
gold standard /
sensitivity /
specificity /
correlation analysis
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参考文献
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