化学发光法检测抗-HEV IgG方法的建立

The establishment and clinical application of a chemiluminescence method of detecting anti-HEV IgG

目的 建立化学发光检测抗HEV IgG方法,用于HEV感染的实验室诊断及流行病学调查,为试剂盒研制打下基础.方法 以HEV重组抗原包被微孑孔板,辣根过氧化物酶标记的单克隆抗人IgG抗体为第二抗体,建立抗HEV IgG的化学发光检测方法,评价其灵敏度、特异性、精密性等指标.检测患者血清中抗HEV IgG抗体并与第三方试剂比较.结果 建立了检测抗HEV IgG的化学发光方法,检测500例临床患者标本并与对照试剂盒对比,阳性符合率为99.32％,阴性符合率为98.58％,总符合率98.80％,其灵敏度、特异性、重复性均达到设计要求.结论 建立了化学发光检测血清中抗-HEV IgG的方法,具有敏感性高、特异性强、操作简便等特点,适用于戊型肝炎的临床诊断和流行病学调查.

Objective To establish a chemiluminescence method for the detection of anti-HEV IgG in laboratory diagnosis,which lay a foundation for the development of an anti-HEV IgG chemiluminescence assay kit.Methods The HEV recombinant antigen and the HRP-monoclonal anti-human IgG were respectively used as coating antigen and secondary antibody to establish the chemiluminescence method.The sensitivity,specificity and accuracy of the established method were evaluated and compared with the thirdparty reagent.Results 500 clinical serum samples were tested both by the established method and a commercialized chemiluminescence assay kit,the coincidence rate of two methods had reached 98.80%.The sensitivity,specificity and repeatability of the established method were proved to meet the requirements of the experiment design.Conclusions A chemiluminescence method of detecting anti-HEV IgG was established.This method has the characteristics of high sensitivity,high specificity,easy of operation,which is definitely applicable in the diagnosis of HEV infection and epidemiological survey.