摘要
〔目的〕分析丙型肝炎病毒(HCV)抗体酶联免疫吸附试验(ELISA)诊断试剂的可信度。〔方法〕本研究对应用2种国产ELISA试剂从大连口岸出入境人员中检出的HCV阳性标本采用免疫印迹试验(RIBA)进行确证,并对检测结果进行综合分析。〔结果〕138份标本中万泰(WT)、丽珠(LZ)2种ELISA试剂检测均为阳性的120份,进行RIBA确证阳性115份,阳性率95.8%;仅WT阳性的10份标本,RIBA确证阳性4份,阳性率40.0%;仅LZ阳性的8份标本,RIBA确证阳性3份,阳性率37.5%。对ELISA检测真阳性和假阳性标本的S/CO值进行统计学处理,发现差异有显著性(P<0.05)。对16份假阳性标本进行RIBA条带分析,其中Core条带有10条,占62.5%;NS3-1条带有3条,占18.8%;NS3-2条带有2条,占12.5%;NS4条带有1条,占6.3%;没有出现NS5条带。〔结论〕本研究的结果与美国疾病预防与控制中心(CDC)在对美国公司所生产的抗HCV试剂可信度评价的基础上规定:当S/CO值在3.8以下时,样品需进行确证方可确定其阴、阳性的要求相一致。当HCV的ELISA检测结果S/CO值较低或1种ELISA试剂检测结果为阴性时应进行RIBA确证试验。
Objective To analyze the reliability of commercial anti-HCV reagent by means of Enzyme-linked Immunosorbent Assay （ELISA）. Method Two kinds of domestic ELISA reagents were administrated in HCV detection for entry-exit personnels at Dalian port, and the positive specimen were confirmed by using Recombinant Immunoblot Assay （RIBA）. Result Of 138 specimen detected, 120 were positive with ELISA, which 115 were confirmed with RIBA, accounting for 95.8%. Of positive specimen tested by only one kind of ELISA reagent （WT）, 40.0% were positive confirmed by RIBA, and 37.5% were confirmed for LZ. The statistical difference was observed in S/CO between true positive and false positive samples （P 〈 0.05）. For 16 false positive specimen, Core was 10（62.5%）, and NS3-1 was 3 （18.8%）, while NS3-2 was 2 （12.5%） and NS4 was 1 （6.3%）, and NS5 was 0 （0.0%）. Conclusion The findings in this study is coincidently consistent with that of US CDC in testing HCV and meet the threshold （S/CO=3.8）,while RIBA test should be utilized for the specimen if S/CO is lower or either kind of ELISA reagent is negative.
出处
《中国国境卫生检疫杂志》
CAS
2009年第1期1-3,共3页
Chinese Journal of Frontier Health and Quarantine
基金
国家质量监督检验检疫总局科研基金项目(2008IK-204)
关键词
肝炎病毒
丙型
免疫印迹试验
酶联免疫吸附试验
可信度
Hepatitis, C type
Recombinant immunoblot assay （RIBA）
Enzyme-linked immunosorbent assay （ELISA）
Reliability
