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方法研究

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

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  • 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
王燕(1973—),女,博士,副主任技师,主要从事自身免疫病及感染免疫方面的研究。Tel:15552866535;E-mail: wangyan881450@ aliyun. com. cn

收稿日期: 2012-12-14

  修回日期: 2013-04-16

  网络出版日期: 2013-10-14

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

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  • Department of Laboratory medicine, General Hospital of Jinan Military Area, Jinan 250031, China

Received date: 2012-12-14

  Revised date: 2013-04-16

  Online published: 2013-10-14

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。

本文引用格式

王燕,尹秋霞,窦恒利 . 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[J]. 标记免疫分析与临床, 2013 , 20(4) : 246 -250 . DOI: 10.11748/bjmy. issn. 1006 -1703.2013.04.016

Abstract

Objective To compare the detection rate of Anti-hepatitis C virus (anti-HCV) with chemilumines- cence 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 coincidence 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 vims infection with CLIA.
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