雅培化学发光法检测HIV的S/CO比值与确证试验的相关性分析  

The correlation of HIV S/CO ratio by Abbott chemiluminescence immunoassay with the confirmation assay

作　　者：罗娜[1] 张劲丰[1] 苏荣[1] 庄健海[1] 竺佳瑶 

机构地区：[1]佛山市中医院检验科,广东佛山528000

出　　处：《中国卫生检验杂志》2017年第19期2794-2796,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的探讨雅培化学发光法检测HIV筛查试验信号/临界值(S/CO)与确证试验的相关性。方法经雅培化学发光法检测HIV S/CO比值≥1.0的血清样本103份,用免疫印迹法(Western blot,WB)对HIV筛查试验结果进行确认评价,采用SPSS 19.0软件绘制HIV S/CO比值受试者工作特性(ROC)曲线,得到雅培化学发光法检测HIV的最佳诊断界点。结果雅培化学发光法检测HIV S/CO比值≥1.0的血清样本103份,WB检测阳性79份,不确定13份,阴性11份,雅培化学发光法与WB的阳性符合率为79.6%。确证试验为HIV-1阳性的样本中,gp160、gp120、gp41、p66、p51、p55、p24条带出现的百分率均≥90%。根据ROC曲线分析,雅培化学发光法检测HIV的最佳诊断界点为15.01S/CO,此时灵敏度为98.7%,特异度为95.8%,漏诊率为1.3%,误诊率为4.2%。结论合理确定雅培化学发光法检测HIV的最佳诊断界点,其灵敏度和特异度较高,误诊率较低,对HIV筛查具有良好的诊断价值。Objective To study the correlation of HIV signal-to-cut off（ S/CO） ratio by chemiluminescence immunoassay（ CLIA） with confirmation assay. Methods A total of 103 HIV positive samples（ S/CO ratio≥1） were screened out by Abbott CLIA system. The results were confirmed by Western blot（ WB）. The best diagnostic point of Abbott chemiluminescence detecting HIV was obtained when SPSS 19. 0 software was used to draw the receiver operating characteristics（ ROC） curve of HIV S/CO ratio. Results By Abbott CLIA,103 samples＇ S/CO ratio（ ≥1. 0） was determined. By WB,79 cases of them were confirmed as positive and 13 cases indeterminate and 11 cases negative. The coincidence rate of Abbott CLIA was 79. 6%. In the samples of HIV-1 tested by confirmation assay positively,the percentages of the occurrences of gp160,gp120,gp41,p66,p51,p55,p24 were not less than 90%. According to the ROC curve analysis,the best diagnostic point for Abbott CLIA system to HIV was 15. 01 S/CO and the sensitivity was 98. 7%,the specificity was 95. 8%,the missed diagnosis rate was 1. 3%,and the misdiagnosis rate was 4. 2%. Conclusion It is important to determine a reasonable diagnostic point for Abbott CLIA system to HIV for not only the higher sensitivity and the lower misdiagnosis rate but also the improvement of determination report.

关 键 词：人类免疫缺陷病毒 化学发光法 免疫印迹法 

分 类 号：R446.62[医药卫生—诊断学]