欧蒙印迹仪EURO Blot MasterⅡ在HIV抗体确证实验中的应用研究

EURO Blot Master Ⅱ Application Research in HIV Confirmatory Test

目的探讨并验证EURO Blot Master Ⅱ(简称EBM II)全自动免疫印迹仪与AUTOBLOT SYSTEM 20(简称AS20)蛋白印迹仪同时进行HIV初筛阳性标本确证实验结果的一致性与相关性,评估EBM Ⅱ全自动免疫印迹仪可以满足HIV抗体确证实验的要求,可以在中国各级疾病预防控制中心及通过认证的HIV确证实验室中使用。方法采用MP公司AS20蛋白印迹仪作为参比仪器,欧蒙EBM Ⅱ全自动免疫印迹仪为实验仪器,两台仪器同时对71例HIV初筛阳性血清标本进行检测。计算其阳、阴性符合率,验证两种仪器对同一样本检测结果的一致性与相关性。结果两台仪器的阳、阴性符合率均达到100%,阳、阴性预测值也都达到了100%。结论 EBM II与AS20的检测结果具有很好的一致性及相关性,完全符合各级疾病预防控制中心及HIV确证实验室的用于HIV抗体确证实验检测的使用要求。

Objective To compare consistency and correlation between EURO Blot Master Ⅱ （EBM Ⅱ） and AUTOBLOT SYSTEM 20 （AS20） in the confirmatory test of HIV screening positive samples, and evaluate competence and application of EBM Ⅱ to HIV antibody confirmatory test in centers for disease control, prevention and certified laboratories in China. Methods EBM Ⅱ was employed to detect 71 HIV screening positive samples, simultaneously using AS20 as the reference device. Both positive and negative coincidence rates were calculated to validate the consistency and correlation between EBM Ⅱ and AS20. Results Both positive and negative coincidence rate between EBM Ⅱ and AS20 were 100% and both PPV and NPV were up to 100%. Conclusion With the strong consistency and good correlation with AS20, EBM Ⅱ could be used to HIV antibody confirmatory test in centers for disease control,prevention and certified laboratories in China.