HCV游离抗原BA-ELISA检测方法的临床应用评价  

Evaluation on clinical application of HCV free antigen detection methods of BA-ELISA

作　　者：龙润乡[1] 陈红英[2] 朱祥明[3] 沈云松[4] 孙翳[4] 苏品璨[3] 王俊[1] 谢忠平[1] 

机构地区：[1]中国医学科学院北京协和医学院医学生物学研究所,云南昆明650118 [2]昆明医学院第一附属医院 [3]云南昆明血液中心 [4]云南省第一人民医院

出　　处：《现代预防医学》2013年第3期526-527,530,共3页Modern Preventive Medicine

基　　金：国家863项目(2007AA02Z480);云南省联合支持国家计划项目(2008GA008)

摘　　要：目的根据国家相关法规对HCV游离抗原BA-ELISA检测方法进行临床应用效果评价。方法生物素标记丙型肝炎病毒抗体(HCV-Ab)与辣根过氧化物酶标记亲和素联合应用建立HCV游离抗原BA-ELISA检测法,分别在3个省级医疗卫生机构进行临床试验,同时使用HCV-cAg、HCV-Ab、HCV-RNA荧光定量检测试剂盒进行对比同步检测。结果临床试剂与HCV-Ab检测结果相比一致性66.67%,特异性100%;与荧光定量PCR相比结果一致性为80.85%、特异性为98.87%;同类市售产品HCV核心抗原检测试剂检测结果与之接近。结论临床试剂特异性较好,灵敏度有待提高;临床研究试剂比市售同类产品阳性检出率略高,但两种试剂检出率均低于核酸及抗体检测试剂。OBJECTIVE According to the national relative regulations, to evaluate effect of clinical application of HCV free antigen BA-ELISA detection method. METHODS Used biotin-labeled hepatitis C virus antibody （HCV-Ab） and horseradish peroxidase -conjugated avidin system to establish of free HCV antigen detection methods of BA-ELISA. Respectively in the three provincial-level medical and health institutions for clinical trials, meanwhile HCV-cAg, HCV-Ab, HCV-RNA fluorescence quantitative detection kit synchronous detection were compared. RESULTS Results of clinical study reagent compared with I-ICV-Ab test results, coincidence rate was 66.67%, specificity 100%; And compared with HCV-PCR, coincidence rate was 80.85%, specificity was 98.87%; The results were analogue by the commercial product HCV-Ag detection reagents and HCV- Ag detection reagents. CONCLUSION Better clinical study reagent specificity, sensitivity need to be improved; clinical study reagents than similar products commercially, positive rate is slightly higher, but both are lower than nucleic acid detection reagent and antibody detection kit.

关 键 词：丙型肝炎病毒 酶联免疫法 生物素-亲和素检测法 临床运用评价 游离抗原 

分 类 号：R373.21[医药卫生—病原生物学]