Biotechnology Research Center, New Damietta City, Egypt.
Arch Med Res. 2012 Oct;43(7):555-62. doi: 10.1016/j.arcmed.2012.09.010. Epub 2012 Oct 17.
Hepatitis C virus (HCV) has emerged as the major pathogen of liver disease worldwide. The aim of this study was to quantitate and evaluate the performance of HCV-NS4 antigen as an alternative approach for confirmation of viremia.
Detection of HCV-NS4 was assessed in 883 patients with chronic hepatitis C. Areas under the ROC curves (AUC) were used to assess and compare diagnostic accuracy of ELISA for HCV-NS4 with quantitative HCV-RNA as a gold standard.
HCV-NS4 was identified at 27 kDa using Western blot. AUC for HCV-NS4 detection was 0.95 for all patients with different liver pathologies: 0.93 for liver fibrosis (LF), 0.95 for liver cirrhosis (LC) and 0.98 for hepatocellular carcinoma (HCC). The mean ± SD (μg/mL) of HCV-NS4 in LF was 94.2 ± 55.6; in LC was 99.3 ± 64.8 and in HCC was 124.9 ± 70.3.
HCV-NS4 antigen detection using ELISA is a reliable test in the confirmation of HCV infection.
丙型肝炎病毒（HCV）已成为全球范围内肝脏疾病的主要病原体。本研究的目的是定量评估 HCV-NS4 抗原作为确认病毒血症的替代方法的性能。
评估了 883 例慢性丙型肝炎患者的 HCV-NS4 检测情况。使用 ROC 曲线下面积（AUC）评估和比较 HCV-NS4 ELISA 检测与定量 HCV-RNA 作为金标准的诊断准确性。
使用 Western blot 在 27 kDa 处鉴定出 HCV-NS4。对于具有不同肝脏病理学的所有患者，HCV-NS4 检测的 AUC 为 0.95：肝纤维化（LF）为 0.93，肝硬化（LC）为 0.95，肝细胞癌（HCC）为 0.98。LF 中 HCV-NS4 的平均值±标准差（μg/mL）为 94.2±55.6；LC 中为 99.3±64.8，HCC 中为 124.9±70.3。
使用 ELISA 检测 HCV-NS4 抗原是确认 HCV 感染的可靠检测方法。
