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学科主题: 临床医学
题名:
Evaluation of the performance of the EIAgen HCV test for detection of hepatitis C virus infection
作者: Rao, Hui-Ying1; Ren, Fu-Rong2; Guan, Wen-Li1; Houde, Michel3; Du, Shao-Cai1; Liu, Chang-Li2; Gong, Xiao-Yan2; Wei, Lai1
关键词: Hepatitis C ; Anti-HCV ; Performance evaluation ; Sensitivity ; Specificity
刊名: JOURNAL OF VIROLOGICAL METHODS
发表日期: 2009-12-01
DOI: 10.1016/j.jviromet.2009.08.008
卷: 162, 期:1-2, 页:203-207
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Biochemical Research Methods ; Biotechnology & Applied Microbiology ; Virology
研究领域[WOS]: Biochemistry & Molecular Biology ; Biotechnology & Applied Microbiology ; Virology
关键词[WOS]: BLOOD-DONORS ; IMPACT ; PREVALENCE ; ANTIBODIES ; ASSAYS ; NAT
英文摘要:

The EIAgen HCV test (Adaltis Inc., Montreal, Canada) is an enzyme immunoassay (EIA) for the detection of anti-hepatitis C virus (HCV) antibodies. This study compared the performance of this test side-by-side with the current Ortho HCV 3.0 Anti-HCV assay (Ortho-Clinical Diagnostics Inc., Johnson & Johnson Company, Raritan, NY, USA). Among 2559 specimens examined, 178 were true positives, 2376 were true negatives and 5 were indeterminate. The sensitivity of the EIAgen HCV test was 100%, versus 98.3% for the Ortho HCV test, while their respective specificities were 98.1% and 98.2%. The EIAgen HCV test gave a positive predictive value of 79.8% and a negative predictive value of 100%. Overall, the concordance of this test with the Ortho HCV test was 98.2%. Specimens from potentially interfering substances, such as sera from pregnant women, sera from patients with acute non-C hepatitis, autoimmune diseases, lipidemia, or from patients undergoing hemolysis, showed no interference with either EIA. An EIAgen HCV test signal-to-cut-off ratio of > 5.9 would be highly predictive of a true-positive finding in these specimens. The EIAgen HCV test is well suited for screening blood and blood products in antibodies to HCV. (c) 2009 Elsevier B.V. All rights reserved.

语种: 英语
所属项目编号: 2005CB522902 ; 2007CB512900 ; 2006AA02A410 ; 30571639 ; 2008ZX70002-012 ; 2008ZX10002-013
项目资助者: Chinese Basic Research Foundation 973 ; 863 program ; NSFC ; National Science and Technology Key Project during the 11th Five-Year Plan Period ; Key Clinical Research Program of Ministry of Health
WOS记录号: WOS:000271586500030
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/55714
Appears in Collections:北京大学第二临床医学院_北京大学肝病研究所_期刊论文

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作者单位: 1.Beijing Red Cross Blood Ctr, Beijing, Peoples R China
2.Adaltis Dev Inc, Laval, PQ, Canada
3.Peking Univ, Peoples Hosp, Inst Hepatol, Beijing 100044, Peoples R China

Recommended Citation:
Rao, Hui-Ying,Ren, Fu-Rong,Guan, Wen-Li,et al. Evaluation of the performance of the EIAgen HCV test for detection of hepatitis C virus infection[J]. JOURNAL OF VIROLOGICAL METHODS,2009,162(1-2):203-207.
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