Yoo Soo Jin, Wang Lan Lan, Ning Hsiao-Chen, Tao Chuan Min, Hirankarn Nattiya, Kuakarn Sunida, Yang Ruifeng, Han Tae Hee, Chan Raymond C, Hussain Baizurah Mohd, Hussin Hazilawati, Muliaty Dewi, Shen Lisong, Liu Hongjing, Wei Lai
Inje University Sanggye Paik Hospital, 1342, Dongilro, Nowon-gu, Seoul 139-707, South Korea.
West China Hospital, Sichuan University, 37 GuoXue Xiang, Chengdu, Sichuan Province 610041, China.
J Clin Virol. 2015 Mar;64:20-7. doi: 10.1016/j.jcv.2014.12.015. Epub 2014 Dec 30.
Early diagnosis of hepatitis C virus (HCV) infection is essential to allow appropriate treatment and prevent transmission.
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.
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.
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.
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.
丙型肝炎病毒（HCV）感染的早期诊断对于进行适当治疗和预防传播至关重要。
使用来自不同亚太人群的大量样本评估Elecsys（®）抗-HCV II检测法作为亚洲常规筛查检测法，并将其性能与该地区常规使用的其他HCV检测法进行比较。
使用医院常规样本确定Elecsys（®）抗-HCV II检测法的敏感性和特异性，并在九个独立中心与以下至少一种比较检测法进行比较：ARCHITECT™抗-HCV；Serodia（®）-HCV颗粒凝集试验；Vitros（®）ECi抗-HCV；Elecsys（®）抗-HCV；ADVIA Centaur（®）HCV；InTec（®）HCV EIA；或丽珠（®）抗-HCV。使用市售的血清转化检测板评估早期感染检测的敏感性。
对于所有六个测试的检测板，Elecsys（®）抗-HCV II检测法在识别早期感染方面更敏感，平均比比较检测法更早检测到急性HCV感染。对7726份常规样本进行了检测，其中322份被鉴定为HCV阳性。Elecsys（®）抗-HCV II的敏感性为100%，特异性为99.66%，两者均与竞争检测法的结果相当或更优，竞争检测法的敏感性和特异性分别为87.5%-100%和98.98%-100%。
Elecsys（®）抗-HCV II检测法具有敏感性和特异性，支持其在亚太地区用作常规筛查方法。此外，与既定方法相比，该检测法缩短了感染与抗体检测之间的诊断窗口期。
