Liver Unit, Vall d'Hebron University Hospital, Barcelona, Spain.
J Med Virol. 2013 Aug;85(8):1362-8. doi: 10.1002/jmv.23536.
Routine screening of patients at risk of hepatitis C virus (HCV) infection has become a priority given recent improvements in therapeutic options and the asymptomatic nature of most chronic infections. The aim of this study was to evaluate the performance of the Elecsys® Anti-HCV II assay, a new qualitative antibody immunoassay, compared with currently available assays, and assess its suitability for routine diagnostic testing. The sensitivity of the Elecsys® Anti-HCV II, ARCHITECT® Anti-HCV, AxSYM® HCV 3.0, PRISM® HCV, Vitros® ECi Anti-HCV, Elecsys® Anti-HCV, and ADVIA Centaur® HCV assays was compared using commercially available seroconversion panels and samples from patients known to be HCV positive and infected with HCV genotypes 1-6. Specificity was investigated using samples from blood donors, unselected hospitalized patients, and patients with potential cross-reacting factors or from high-risk groups. The Elecsys® Anti-HCV II assay detected more positive bleeds than the comparator assays, was more sensitive in recognizing early HCV infection, and correctly identified all 765 samples known to be HCV positive, regardless of genotype. The overall specificity of the Elecsys(®) Anti-HCV II assay was 99.84% (n=6,850) using blood donor samples, 99.66% (n=3,922) using samples from unselected hospitalized patients, and 99.66% (n=2,397) using samples from patients with potentially cross-reacting factors or from high-risk groups. The specificity of the Elecsys® Anti-HCV II assay was superior or equal to the comparator assays. In conclusion, the Elecsys® Anti-HCV II assay is a sensitive and specific assay suitable for routine use in the reliable detection of anti-HCV antibodies.
常规筛查丙型肝炎病毒 (HCV) 感染高危患者已成为当务之急，这是因为最近治疗方案的改进和大多数慢性感染的无症状性质。本研究旨在评估 Elecsys® Anti-HCV II 检测法，一种新的定性抗体免疫分析法，与现有检测方法相比的性能，并评估其用于常规诊断检测的适用性。使用市售的血清学转换试剂盒和已知 HCV 阳性且感染 HCV 基因型 1-6 的患者样本，比较 Elecsys® Anti-HCV II、ARCHITECT® Anti-HCV、AxSYM® HCV 3.0、PRISM® HCV、Vitros® ECi Anti-HCV、Elecsys® Anti-HCV 和 ADVIA Centaur® HCV 检测法的灵敏度。使用献血者样本、非选择性住院患者样本和具有潜在交叉反应因素或来自高危人群的患者样本，调查其特异性。Elecsys® Anti-HCV II 检测法比对照检测法检测到更多的阳性样本，在识别早期 HCV 感染方面更敏感，并且正确识别了所有 765 份已知 HCV 阳性的样本，无论基因型如何。使用献血者样本时，Elecsys® Anti-HCV II 检测法的总体特异性为 99.84%（n=6850），使用非选择性住院患者样本时为 99.66%（n=3922），使用具有潜在交叉反应因素或来自高危人群的患者样本时为 99.66%（n=2397）。Elecsys® Anti-HCV II 检测法的特异性优于或等同于对照检测法。总之，Elecsys® Anti-HCV II 检测法是一种敏感和特异性的检测法，适用于常规使用，可可靠地检测抗 HCV 抗体。
