金标法初筛试剂与诊断试剂检测乙肝表面抗原的结果分析

目的:分析金标法初筛试剂与诊断试剂检测无偿献血者乙肝表面抗原的阳性率、假阳性率及假阴性率的结果。方法:金标法初筛试纸条检测68 326例,诊断试纸条检测55 637例,乙肝表面抗原初检阴性者与初检阳性者均用ELISA法做复检。结果:初筛试剂检测68 326例的HBsAg阳性率为5.96%、假阳性率5.8%、假阴性率2.84%,诊断试剂检测55 637例的阳性率为2.77%、假阳性率2.6%、假阴性率0.47%。结论:金标法初筛试剂检测无偿献血者乙肝表面抗原的阳性率、假阳性率及假阴性率均高于诊断试剂。

Results analysis of testing HBsAg with preliminary test reagent and diagnostic reagent of colloidal gold-labeled method

Objective：To analyze the results of positive rate, false positive rate and false negative rate of testing the voluntary blood donors＇ HBsAg with preliminary test reagent and diagnostic reagent of colloidal gold-labeled method. Method：68 326 voluntary blood donors were tested with the preliminary test reagent of colloidal gold-labeled method and 55 637 voluntary blood donors were tested with the diagnostic reagent of colloidal gold-labeled method,all those who were hepatitis B surface antigen negative and who were positive were retested with ELISA. Result：The positive rate, false positive rate and false negative rate of HBsAg among 68 326 voluntary blood donors who were tested with the preliminary test reagent of colloidal gold-labeled method were 5. 96%,5. 8% and 2. 84%, respectively. The positive rate, false positive rate and false negative rate of HBsAg among 55 637 voluntary blood donors who were tested with the diagnostic reagent of colloidal gold-labeled method was 2.77%,2.6% and 0.47%, respectively. Conclusion： The positive rate, false positive rate and false negative rate of the voluntary blood donors＇ HBsAg which were tested with the preliminary test reagent of colloidal gold labeled method were higher than those of the diagnostic reagent of colloidal gold-labeled method.