化学发光法和酶联免疫法作为筛选试验测定丙肝抗体的评价  

Screening Test of Hepatitis C Antibody by Chemiluminescent Assay and Enzyme Immunoassay

作　　者：王燕[1] 尹秋霞[1] 窦恒利[2] 

机构地区：[1]济南军区总医院实验诊断科,山东济南250031 [2]济南市立四院,山东济南250031

出　　处：《标记免疫分析与临床》2013年第4期246-250,共5页Labeled Immunoassays and Clinical Medicine

摘　　要：目的比较化学发光法(CLIA)和酶联免疫法(EIA)测抗-HCV对诊断HCV感染的检出率,分析CLIA测定抗-HCV作为HCV感染初筛试验的重要临床意义。方法分别用CLIA、EIA方法检测所有临床标本中的抗-HCV,选取抗-HCV初筛阳性样本进行HCV RNA确认试验。结果 6461例样本中,EIA和CLIA测抗-HCV阳性率分别为2.86%和3.17%;确认试验中,CLIA法抗-HCV阳性与HCV RNA的符合率为97.1%,显著高于EIA组(91.9%)。EIA法测抗-HCV,S:CO>5.0以上,与HCV RNA检测符合率可达100%;弱阳性样本,与HCV RNA符合率为69.7%;CLIA法测抗-HCV,S:CO>2.0以上,与HCV RNA检测符合率可达100%;弱阳性样本,与HCV RNA符合率为92.9%。有31例样本CLIA法抗-HCV和HCV RNA阳性,而EIA法抗-HCV阴性;有4例样本EIA法检测为阳性,而CLIA法和PCR确认试验均为阴性。结论CLIA法测抗-HCV作为HCV感染初筛实验,与传统EIA相比,特异性和阳性预测值更高,有效降低了假阳性率,有利于临床医生对HCV感染患者的早期诊断和治疗。Objective To compare the detection rate of Anti-hepatitis C virus （anti-HCV） with chemiluminescence immunoassay （CLIA） and enzyme immunoassay （EIA）, and explore the clinical significance of CLIA in diagnosis of HCV infection. Methods The anti-HCV in 6461 patient samples were detected by CLIA and EIA respectively, and anti-HCV positive samples were Confirmed with HCV-RNA test. Results The positive rate of anti-HCV in 6461 patient samples determined by CLIA and EIA were 3.17% and 2.86%, respectively. The positive coincidence ratio of CLIA detection confirmed by HCV RNA assay （97.1% ） was obviously higher than that of EIA （91.9%）. Among EIA detection samples, while S：CO value was more than 5.0, the positive coin- cidence ratio confirmed by HCV RNA was 100%. In weak positive samples, the positive coincidence ratio was only 69.7%. Among CLIA detection samples, while S ：CO value was more than 2.0, the positive coincidence ratio confirmed by HCV RNA was 100%. In weak positive samples, the positive coincidence ratio was 92.9%. 31 anti-HCV positive samples detected by CLIA were negative detected by EIA. 4 anti-HCV positive samples detected by EIA were negative detected by CLIA. Conclusion CLIA provides higher specificity and positive predictive value than EIA, and reduces false-positive results. It is effective laboratory procedures for early diagnosis and treatment monitor of hepatitis C virus infection with CLIA.

关 键 词：丙型肝炎抗体 酶联免疫法 化学发光免疫测定 

分 类 号：R446.61[医药卫生—诊断学]