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学科主题: 临床医学
题名:
Evaluation of the Elecsys (R) Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection
作者: Yoo, Soo Jin1; Wang, Lan Lan2; Ning, Hsiao-Chen3; Tao, Chuan Min2; Hirankarn, Nattiya4,5; Kuakarn, Sunida4,5; Yang, Ruifeng6; Han, Tae Hee1; Chan, Raymond C.7; Hussain, Baizurah Mohd8; Hussin, Hazilawati8; Muliaty, Dewi9; Shen, Lisong10; Liu, Hongjing10; Wei, Lai6
关键词: Elecsys (R) Anti-HCV II ; Asia ; Assay ; Sensitivity ; Seroconversion sensitivity ; Specificity
刊名: JOURNAL OF CLINICAL VIROLOGY
发表日期: 2015-03-01
DOI: 10.1016/j.jcv.2014.12.015
卷: 64, 页:20-27
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Virology
研究领域[WOS]: Virology
关键词[WOS]: TO-CUTOFF RATIOS ; PERFORMANCE EVALUATION ; VIROLOGICAL TOOLS ; EPIDEMIOLOGY ; MANAGEMENT ; DIAGNOSIS
英文摘要:

Background: Early diagnosis of hepatitis C virus (HCV) infection is essential to allow appropriate treatment and prevent transmission.

Objectives: To evaluate the Elecsys (R) Anti-HCV II assay as a routine screening assay in Asia using a large number of samples from different Asian Pacific populations and compare its performance with other HCV assays routinely used in the region.

Study design: The sensitivity and specificity of the Elecsys (R) Anti-HCV II assay were determined using routine hospital samples and compared with at least one of the following comparator assays at nine independent centers: ARCHITECT (TM) Anti-HCV; Serodia (R)-HCV Particle Agglutination; Vitros (R) ECi Anti-HCV; Elecsys (R) Anti-HCV; ADVIA Centaur (R) HCV; InTec (R) HCV EIA; or Livzon (R) Anti-HCV. Commercially available seroconversion panels were used to assess sensitivity for early detection of infection.

Results: The Elecsys (R) Anti-HCV II assay was more sensitive in recognizing early infection and detected acute HCV infection earlier on average than the comparator assays for all six panels tested. 7,726 routine samples were tested and 322 identified as HCV positive. Elecsys (R) Anti- HCV II had a sensitivity of 100% and a specificity of 99.66%, both of which were comparable or superior to the results obtained for competitor assays, which ranged from 87.5-100% and 98.98-100%, respectively.

Conclusions: The Elecsys (R) Anti-HCV II assay has the sensitivity and specificity to support its use as a routine screening method in the Asia Pacific region. Furthermore, this assay shortens the diagnostic window between infection and the detection of antibodies compared with established methods. (C) 2015 The Authors. Published by Elsevier B.V.

语种: 英语
项目资助者: Roche Diagnostics GmbH (Penzberg, Germany)
WOS记录号: WOS:000352273600005
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/53817
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.Chulalongkorn Univ, Fac Med, Bangkok 10330, Thailand
2.King Chulalongkorn Mem Hosp, Bangkok 10330, Thailand
3.Royal Prince Alfred Hosp, Sydney, NSW 2050, Australia
4.Hosp Ampang, Ampang 68000, Selangor De, Malaysia
5.Prodia Clin Lab, Jakarta 10430, Indonesia
6.Inje Univ, Sanggye Paik Hosp, Seoul 139707, South Korea
7.Chang Gung Mem Hosp, Gueishan 333, Taoyuan County, Taiwan
8.Sichuan Univ, West China Hosp, Chengdu 610041, Sichuan Provinc, Peoples R China
9.Peking Univ, Peking Univ Peoples Hosp, Inst Hepatol, Beijing Key Lab Hepatitis C & Immunotherapy Liver, Beijing 100044, Peoples R China
10.Shanghai Jiao Tong Univ, Sch Med, Xin Hua Hosp, Shanghai 200092, Peoples R China

Recommended Citation:
Yoo, Soo Jin,Wang, Lan Lan,Ning, Hsiao-Chen,et al. Evaluation of the Elecsys (R) Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection[J]. JOURNAL OF CLINICAL VIROLOGY,2015,64:20-27.
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