国产抗-HEV IgG ELISA试剂盒阳性临界值讨论

Discussion on positive threshold of domestic anti-HEV IgG ELISA kit

目的确定上海科华生物公司生产的抗-HEV IgG ELISA试剂盒阳性临界值,为自然人群抗-HEV IgG流行率调查提供依据。方法选择本实验室保存的不同来源血清样本,采用上海科华公司生产的抗-HEV IgG ELISA试剂盒进行检测。以Genelabs抗-HEV IgG试剂为标准,应用ROC曲线法确定科华公司试剂检测自然人群抗-HEV IgG时合理的阳性临界值。结果以ROC曲线确定的约登指数最大值(0.848)相应的切点为科华试剂阳性临界值(0.071)。结论 ROC曲线有助于获得合理的阳性临界值。

Objective Defining reasonable positive threshold for sero-prevalence of anti-HEV IgG among the general population. Methods The positive threshold of Anti-HEV IgG ELISA kit from KeHua Inc. for general population was identified using ROC analysis with stored serums as the materials, and kit from Genelabs Inc. as the standard method. Results The threshold of Kehua＇s kit was identified as the tangency point （0.071） corresponding to the maximal value of Youden’s Index （0.848）. Conclusions Reasonable positive threshold could be achieved by using ROC method.