人巨细胞病毒pp65 IgG-AI快速诊断试剂的临床应用  

Evaluation of Clinical Application of Rapid Diagnostic Kit for Human Cytomegalovirus pp65 IgG-AI

作　　者：刘倩[1] 黄维[1] 崔寰[1] 陈敬贤[1] 王明丽[1] 

机构地区：[1]安徽医科大学微生物学教研室安徽省重要遗传病基因资源利用重点实验室生物工程部,合肥230032

出　　处：《中国生物制品学杂志》2008年第4期323-326,共4页Chinese Journal of Biologicals

基　　金：安徽省"十五"生物医药重大科技专项(编号:01303003);安徽省教育厅自然科学基金项目(编号:2006KJ320B)

摘　　要：目的评价人巨细胞病毒(Human cytomegalovirus,HCMV)pp65 IgG-亲和力指数(Avidity index,AI)快速诊断试剂的临床应用价值。方法以自制的截短pp65重组蛋白作为诊断试剂,对本室血清库中保存的标本,采用ELISA间接法检测其特异性IgG抗体,分析该试剂的灵敏度、特异性和准确度。检测临床收集的89份患者血清标本(其中5例被明确诊断为HCMV活动性感染)的pp65 IgG抗体,并与意大利DIESSE公司IgG检测试剂盒结果进行比较。同时,对pp65 IgG阳性标本,运用尿素变性ELISA间接法检测其AI值,与意大利DIESSE公司IgM检测试剂盒结果进行比较,评价AI检测在HCMV感染诊断中的价值。结果用pp65快速诊断试剂检测阳性、阴性血清特异性IgG抗体,均与原确认结果相同,灵敏度、准确度和特异性均达100%。两种诊断试剂IgG抗体检测结果,差异无显著意义。pp65诊断试剂对pp65 IgG阳性标本的AI值进行检测,AI<60%标本共41份,阳性率为46.07%,较参比试剂IgM检测阳性率(23.59%)高;5份明确诊断HCMV活动性感染的患者血清标本中,pp65诊断试剂与参比试剂检测IgG抗体,各有4份阳性,一致率为100%,pp65诊断试剂检测AI值为阳性的标本有3份,其中,参比试剂检测IgM为阳性的仅有1份。临床明确诊断为HCMV肺炎的患者血清标本,诊断试剂检测AI值为可疑阳性,但参比试剂检测HCMV IgM抗体为阴性。结论pp65 IgG-AI快速诊断试剂可初步诊断HCMV感染,简单快速,重复性好,具有良好的临床应用前景。Objective To evaluate the clinical application of rapid diagnostic kit for human cytomegalovirus （HCMV） pp65 IgG-avidity index （AI）.Methods Determine the specific IgG in confirmed positive and negative serum specimens preserved in our laboratory with prepared HCMV pp65 IgG-AI kit by indirect ELISA to analyze the sensitivity, specificity and accuracy. Determine the pp65 IgG in 89 serum specimens collected in clinic, of which 5 were from the patients with active HCMV infection, by the prepared kit, and compare the results with those by imparted kit. In addition, determine the AI values of pp65 IgG positive specimens by indirect ELISA using urea as protein denaturant and compare the results with those by imported IgM kit to evaluate the significance of AI in diagnosis of HCMV infection. Results All the determination results of confirmed positive and negative serum specimens were identical to those confirmed previously, indicating that the sensitivity, specificity and accuracy of prepared kit were 100%. The determination results of IgG by prepared and imported kits showed no significant difference. By determination of AI value with prepared kit, the primary （ or suspected primary） HCMV infection rate of patients from whom the clinical specimens were collected was 46.07%, which was significantly higher than that by determination of IgM with reference kit （23.59%）. Of the 5 specimens diagnosed as active HCMV infection,4 were proved as IgG positive by either prepared or reference kit, indicating that the coninicidence rate of the two kits was 100%. However,3 of the 5 specimens were proved as positive by determination of AI value with the prepared kit, while only one as positive by determination of IgM with reference kit. The specimens from patients with HCMV pulmonitis diagnosed in clinic were proved as positive by determination of AI value with the prepared kit, but as negative by determination of IgM with reference kit. Conclusion The developed rapid diagnostic kit for pp65 IgG-AI may be used for preli

关 键 词：人巨细胞病毒 pp65重组抗原 亲和力指数 诊断试剂 临床应用 

分 类 号：R392-33[医药卫生—免疫学] R373.9[医药卫生—基础医学]