丙型肝炎病毒抗体酶联免疫吸附试剂检测结果可信度的分析

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。

Reliability of Enzyme-linked Immunosorbent Assay(ELISA) in Testing of Commercial Anti-HCV Diagnostic Reagent

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...