CAJ | 학술논문

目的应用大肠杆菌表达的戊型肝炎病毒(HEV)重组抗原建立HEV IgG抗体诊断(ELISA)试剂盒.方法应用大肠杆菌表达的具有戊型肝炎主要抗原表位的表达蛋白HEV ORF23作为包被抗原,建立检测血清中抗HEV IgG的间接ELISA试剂盒.通过HEV IgG试剂盒对100份戊型肝炎患者血清和150份正常人阴性血清测定结果进行比较,评价本试剂盒的特异性、敏感性及稳定性.另选临床500份肝炎患者血清进行检测,评价本试剂盒的临床应用价值.结果建立的抗HEV IgG间接ELISA试剂盒特异性、敏感性均为100%,重复性较好,在4℃至少可稳定存放6个月,与同类试剂的符合率为95%以上.500份血清样本中,戊型肝炎患者150例,检出HEV145份,阳性符合率为96.67%.结论应用大肠杆菌表达的HEV重组抗原建立的检测试剂盒对血清抗HEV IgG的检测具有良好的特异性和敏感性,在戊型肝炎的临床诊断和流行病学调查中具有潜在的应用价值.
목적 응용대장간균표체적무형간염병독(HEV)중조항원건립HEV IgG항체진단(ELISA)시제합.방법 응용대장간균표체적구유무형간염주요항원표위적표체단백HEV ORF23작위포피항원,건립검측혈청중항HEV IgG적간접ELISA시제합.통과HEV IgG시제합대100빈무형간염환자혈청화150빈정상인음성혈청측정결과진행비교,평개본시제합적특이성、민감성급은정성.령선림상500빈간염환자혈청진행검측,평개본시제합적림상응용개치.결과 건립적항HEV IgG간접ELISA시제합특이성、민감성균위100%,중복성교호,재4℃지소가은정존방6개월,여동류시제적부합솔위95%이상.500빈혈청양본중,무형간염환자150례,검출HEV145빈,양성부합솔위96.67%.결론 응용대장간균표체적HEV중조항원건립적검측시제합대혈청항HEV IgG적검측구유량호적특이성화민감성,재무형간염적림상진단화류행병학조사중구유잠재적응용개치.
Objective To establish an EliSA kit for serum anti-hepatitis E virus IgG detection using recombinant antigen expressed in E. Coli. Methods Utilizing the recombinant protein ORF23 of REV expressed in E. Coli as a coating antigen, the ELISA kit for detecting serum anti-HEV IgG was established. The serum samples from 100 HEV patients and 150 negative serum samples were measured, and the detecting results was compared with those of other two HEV kits(the kits from Genelabs company and Wantai Corporation). The specificity, sensitivity and stability of the kit were evaluated. The serum samples from another 500 clinical hepatitis patients were detected to evaluate the clinical application value of this kit. Results Both the specificity and sensitivity of the kit were 100% and the consistency rates to other kits were more than 95%. The kit showed a good stability and could be stable for at least 6 months under 4 ℃. 500 samples were 145 positive in 150 hepatitis E patients, the consistency rates were 96.67% . Conclusions The ELBA kit prepared with HEV recombinant antigen has good specificity and sensitivity for detecting anti-HEV IgG in serum, and may have potential evaluation in clinical diagnosis and epidemiological investigation for hepatitis E.