CAJ | 학술논문

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.
목적 건립화학발광검측항HEV IgG방법,용우HEV감염적실험실진단급류행병학조사,위시제합연제타하기출.방법 이HEV중조항원포피미혈공판,랄근과양화물매표기적단극륭항인IgG항체위제이항체,건립항HEV IgG적화학발광검측방법,평개기령민도、특이성、정밀성등지표.검측환자혈청중항HEV IgG항체병여제삼방시제비교.결과 건립료검측항HEV IgG적화학발광방법,검측500례림상환자표본병여대조시제합대비,양성부합솔위99.32％,음성부합솔위98.58％,총부합솔98.80％,기령민도、특이성、중복성균체도설계요구.결론 건립료화학발광검측혈청중항-HEV IgG적방법,구유민감성고、특이성강、조작간편등특점,괄용우무형간염적림상진단화류행병학조사.
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.