部分艾滋病抗体诊断试剂盒检测效果研究

Study on the Quality of Some HIV Antibody Diagnosis Reagents

[目的]了解现有HIV诊断试剂的敏感性、特异性等性能,以便更好的应用于艾滋病抗体检测。[方法]以免疫印迹法(WB)为金标准,用13种诊断试剂对100份样本进行对比检测并统计分析。[结果]13种诊断试剂与WB法检测结果的差异均无统计学意义。[结论]13种诊断试剂均可达到卫生部《HIV抗体诊断试剂临床评估方案的实施办法》中有关试剂的要求。

[Objective]To understand the sensitivities and specialties of some HIV antibody diagnosis reagents and to give more information on HIV antibody testing. [Methods]100 blood serum samples were tested separately by 13 kinds of HIV antibody diagnosis reagents,and all the testing results were compared to that of WB which was the gold standard method. [Results]There was no statistical difference between each result of 13 kinds of HIV antibody diagnosis reagents and WB. [Conclusion]The 13 kinds of HIV antibody diagnosis reagents were up to the national mustard.