Evaluation of the Elecsys(®) Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection.
BACKGROUND
Early diagnosis of hepatitis C virus (HCV) infection is essential to allow appropriate treatment and prevent transmission.


OBJECTIVE
To evaluate the Elecsys(®) 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.


METHODS
The sensitivity and specificity of the Elecsys(®) 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™ Anti-HCV; Serodia(®)-HCV Particle Agglutination; Vitros(®) ECi Anti-HCV; Elecsys(®) Anti-HCV; ADVIA Centaur(®) HCV; InTec(®) HCV EIA; or Livzon(®) Anti-HCV. Commercially available seroconversion panels were used to assess sensitivity for early detection of infection.


RESULTS
The Elecsys(®) 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(®) 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(®) 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.
Inje University Sanggye Paik Hospital, 1342, Dongilro, Nowon-gu, Seoul 139-707, South Korea. Electronic address: sjyoo@paik.ac.kr.
Soo Jin
SJ
Yoo
West China Hospital, Sichuan University, 37 GuoXue Xiang, Chengdu, Sichuan Province 610041, China. Electronic address: wangll87@126.com.
Lan Lan
LL
Wang
Chang Gung Memorial Hospital, 5 Fusing Street, Gueishan Township, Taoyuan County 333, Taiwan ROC. Electronic address: ning@adm.cgmh.org.tw.
Hsiao-Chen
HC
Ning
West China Hospital, Sichuan University, 37 GuoXue Xiang, Chengdu, Sichuan Province 610041, China. Electronic address: taochuanmin@sina.com.
Chuan Min
CM
Tao
Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, 1873 Rama Road, Pathumwan, Bangkok 10330, Thailand. Electronic address: nattiya.h@chula.ac.th.
Nattiya
N
Hirankarn
Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, 1873 Rama Road, Pathumwan, Bangkok 10330, Thailand. Electronic address: sunida_80@hotmail.com.
Sunida
S
Kuakarn
Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Xizhimen South Street No 11, Xicheng District, Beijing 100044, China. Electronic address: yangruifeng103@live.cn.
Ruifeng
R
Yang
Inje University Sanggye Paik Hospital, 1342, Dongilro, Nowon-gu, Seoul 139-707, South Korea. Electronic address: taeheehan@paik.ac.kr.
Tae Hee
TH
Han
Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia. Electronic address: raymond.chan@sswahs.nsw.gov.au.
Raymond C
RC
Chan
Hospital Ampang, Jalan Mewah Utara, Pandan Mewah, 68000 Ampang, Selangor DE, Malaysia. Electronic address: baizurah@moh.gov.my.
Baizurah Mohd
BM
Hussain
Hospital Ampang, Jalan Mewah Utara, Pandan Mewah, 68000 Ampang, Selangor DE, Malaysia. Electronic address: drhazila@yahoo.com.
Hazilawati
H
Hussin
Prodia Clinical Laboratory, Kramat Raya Street No. 150, Jakarta 10430, Indonesia. Electronic address: dewi.liusvia@prodia.co.id.
Dewi
D
Muliaty
Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, 1665 Kong Jiang Road, Shanghai 200092, China. Electronic address: lisongshen@hotmail.com.
Lisong
L
Shen
Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, 1665 Kong Jiang Road, Shanghai 200092, China. Electronic address: hongjingliu@hotmail.com.
Hongjing
H
Liu
Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Xizhimen South Street No 11, Xicheng District, Beijing 100044, China. Electronic address: weilai@pkuph.edu.cn.
Lai
L
Wei
D000914:Antibodies, Viral / Q000097:blood*; D001208:Asia; D042241:Early Diagnosis; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008163:Luminescent Measurements; D008403:Mass Screening; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity
D000914:Antibodies, Viral; D011933:Reagent Kits, Diagnostic
Asia; Assay; Elecsys(®) Anti-HCV II; Sensitivity; Seroconversion sensitivity; Specificity