目的：对国外丁型肝炎病毒（HDV ）抗体检测试剂盒的性能进行研究和对比分析。方法对采集的1000份血清样本分别用考核试剂、参比试剂和第三方试剂进行检测后使用统计学方法进行结果处理，并依据S/Co值来判断。结果 Kappa分析显示Kappa值为0．950（P＜0．01）。特异性100％，敏感性97．73％，ROC曲线下面积0．986。结论该检测试剂盒的准确性比较高，与目前国内使用比较广泛的诊断试剂盒相比有较高的一致性，通过提高丁型肝炎的临床检出率，对疾病的预防、早期诊断及治疗起到一定的辅助作用。%Objective To conduct the study and comparative analysis on the performance of foreign hepatitis D virus (HDV) an-tibody test kits .Methods The collected 1 000 serum samples were tested by 3 kinds of different reagent :test reagent ,reference rea-gent and third party reagent .The detection results were processed by the statistical method and the judgement was performed base on the S/Co value .Results The Kappa analysis showed that the Kappa value was 0 .950(P<0 .01) .The specificity was 100% ,the sensitivity was 97 .73% and the area under ROC was 0 .986 .Conclusion The test kit has a relatively high accuracy and high consis-tency compared with the diagnostic reagent kits now widely used in domestic .Increasing the clinical detection rate of HDV can play a helping role on prevention ,early diagnosis and treatment of the disease .
展开▼
