2种检测人肾综合征出血热IgG抗体ELISA试剂盒的比较  

Comparison of two ELISA kits for the detection of the IgG antibodies against hemorrhagic fever with renal syndrome

作　　者：李卓[1,2] 曾汉玉 马樱 刘媛[1] 张戎[1] 刘美宁[3] 陈丽华 

机构地区：[1]第四军医大学免疫学教研室,西安710032 [2]西安市卫生学校医学检验教研室,710054 [3]咸阳市疾病预防控制中心,712046

出　　处：《传染病信息》2015年第2期92-95,共4页Infectious Disease Information

基　　金：国家科技重大专项(2013ZX1004609);国家自然科学基金青年项目(81401297)

摘　　要：目的探讨国产与进口人肾综合征出血热(hemorrhagic fever with renal syndrome,HFRS)Ig G抗体ELISA检测试剂盒的性能差异。方法采用国产和进口ELISA试剂盒分别检测50例HFRS疫苗接种者血清样本中抗人HFRS Ig G抗体含量,分析比较2种ELISA试剂盒的一致性、灵敏性、精密度以及方法学等的差异。结果 2种ELISA试剂盒的精密度良好,批内变异系数均<5%;2种试剂阳性一致率为100%,阴性一致率为20%,相似率为60%;灵敏性检测结果显示,2种ELISA试剂盒的灵敏性差异较大(P<0.05),国产ELISA试剂盒的灵敏度约是进口ELISA试剂盒的5倍。结论国产人HFRS Ig G抗体ELISA检测试剂盒灵敏性好,进口ELISA试剂盒特异性好,国产和进口ELISA试剂盒的精密度均良好,在实际应用中应根据具体情况合理选用。Objective To investigate the performance differences in detecting hemorrhagic fever with renal syndrome （HFRS） IgG Antibodies between domestic and imported ELISA kits. Methods Domestic and imported ELISA kits were used to detect HFRS IgG antibodies of the serum samples from 50 HFRS vaccinators, and the consistency, sensitivity, precision and methodology of the two ELISA kits were analyzed. Results Precision test showed that both the domestic and the imported ELISA kits had good precision, with the batch coefficient of variation of less than 5%. The positive consistency rate of the two ELISA kits was 100%, the negative consis- tency rate was 20%, and the similarity rate was 60%. The sensitivity of the domestic ELISA kits was 5 times higher than that of the imported ELISA kits, and the difference was significant between the two ELISA kits （P〈0.05）. Conclusions The sensitivity of the do- mestic ELISA kits is higher than that of the imported ELISA kits, the specificity of the imported ELISA kits is higher than that of the domestic ELISA kits, and both the domestic ELISA kits and the imported ELISA kits have good precision for the detection of HFRS IgG antibodies. The selection and application of the domestic or the imported ELISA kits depend on specific requirements.

关 键 词：汉坦病毒 肾综合征出血热 抗体 酶联免疫吸附测定 

分 类 号：R373.32[医药卫生—病原生物学] R512.8[医药卫生—基础医学]