Ansaldi F, Bruzzone B, Testino G, Bassetti M, Gasparini R, Crovari P, Icardi G
Department of Health Sciences, University of Genoa, Genoa, Italy.
J Viral Hepat. 2006 Jan;13(1):5-10. doi: 10.1111/j.1365-2893.2005.00646.x.
Reduction of the window period of hepatitis C virus (HCV) infection represents an important goal in the transfusional and diagnostic setting. A prototype assay designed to simultaneously detect circulating HCV antigen and anti-HCV, has been developed. Aim of this study was to evaluate the performance of this new assay in terms of specificity and sensitivity and to compare its efficacy with commercial assays. To evaluate the specificity of the assay, 400 samples from the general population and 100 'difficult' sera, negative for anti-HCV, were tested. To assess sensitivity, the new test was used on 76 PCR-positive and anti-HCV negative sera, seven natural or commercial seroconversion panels that included 17 RNA-positive and anti-HCV negative sera and 31 anti-HCV positive sera, 20 weak anti-HCV positive sera, 80 viraemic and anti-HCV-positive sera from patients infected with different subtypes and 10 sera from patients with HBV-HCV or HIV-HCV co-infections. Of 500 anti-HCV negative samples, 499 (99.8%) were negative with a cut-off index <0.5, while one sample was within the grey zone. Of the 93 HCV-RNA positive and anti-HCV negative sera from patients and panels, 85 (91.4%) resulted positive, and one had the cut-off index in the grey zone. The reduction in the diagnostic window period observed with the new test and HCV-RNA assays were equal, on average, to 24 and 34.4 days respectively. All anti-HCV positive sera were positive. The new assay shows high sensitivity and specificity and could be a useful tool not only in the diagnostic setting, where procedures to reduce the window period, such as antigen or HCV-RNA detection, are not currently recommended, but also in the screening of blood donations, when nucleic acid technologies is not feasible because of costs, organization, emergency and/or logistic difficulties.
缩短丙型肝炎病毒（HCV）感染的窗口期是输血和诊断领域的一个重要目标。现已开发出一种旨在同时检测循环HCV抗原和抗-HCV的原型检测方法。本研究的目的是评估这种新检测方法的特异性和敏感性，并将其与商业检测方法的效果进行比较。为评估该检测方法的特异性，对400份来自普通人群的样本和100份抗-HCV阴性的“疑难”血清进行了检测。为评估敏感性，该新检测方法用于检测76份PCR阳性且抗-HCV阴性的血清、7个天然或商业血清转换样本组，其中包括17份RNA阳性且抗-HCV阴性的血清和31份抗-HCV阳性的血清、20份抗-HCV弱阳性血清、80份来自感染不同亚型患者的病毒血症且抗-HCV阳性的血清以及10份HBV-HCV或HIV-HCV合并感染患者的血清。在500份抗-HCV阴性样本中，499份（99.8%）在临界指数<0.5时为阴性，而1份样本处于灰色区域。在来自患者和样本组的93份HCV-RNA阳性且抗-HCV阴性的血清中，85份（91.4%）结果为阳性，1份临界指数处于灰色区域。新检测方法和HCV-RNA检测方法观察到的诊断窗口期缩短平均分别为24天和34.4天。所有抗-HCV阳性血清均为阳性。这种新检测方法具有高敏感性和特异性，不仅在诊断领域（目前不推荐采用缩短窗口期的程序，如抗原或HCV-RNA检测）可能是一种有用的工具，而且在因成本、组织、紧急情况和/或后勤困难而无法采用核酸技术的献血筛查中也可能是一种有用的工具。
