HCV Duo用于HCV感染筛查的诊断效能分析

Analysis of Diagnostic Performance of HCV Duo for HCV Infection Screening

摘要: 目的：分析Elecsys® HCV Duo抗原抗体联合检测在丙型肝炎病毒(HCV)感染筛查中的诊断效能，为临床开展丙肝分层筛查提供依据。方法：收集2025年10月至2026年5月于眉山市中医医院接受HCV抗体检测的患者血清标本298份，以HCV-RNA检测结果为金标准，比较HCV Duo联合检测、抗体及抗原组分的灵敏度、特异性、阳性预测值、阴性预测值。结果：298份标本中HCV RNA阳性62例、阴性236例，HCV Duo-Ag阳性48例、阴性250例，HCV Duo-Ab阳性191例、阴性107例。以HCV-RNA检测结果为标准，HCV Duo联合检测时，阳性191例，真阳性62例，假阳性129例，真阴性107例。HCV Duo联合检测、HCV Duo-Ab检测的灵敏度和阴性预测值均显著高于HCV Duo-Ag检测(P < 0.05)，HCV Duo-Ag检测特异性、阳性预测值和诊断准确率均显著高于HCV Duo联合检测、HCV Duo-Ab检测(P < 0.001)。在RNA阳性标本中，HCV Duo-Ag与HCV Duo-Ab组分检出率分别为77.42%和100% (P < 0.001)。在RNA阴性标本中，HCV Duo-Ag与HCV Duo-Ab组分的假阳性率分别为0%和54.66% (P < 0.001)。结论：HCV Duo-Ag的高特异性与HCV Duo-Ab的高灵敏度形成了良好的互补关系，为HCV Duo联合检测的策略设计提供了理论依据。临床可采用分层筛查策略，兼顾筛查漏诊风险与核酸检测成本，优化丙肝规范化筛查流程。

Abstract: Objective: To analyze the diagnostic efficacy of Elecsys® HCV Duo antigen-antibody combined assay in screening for hepatitis C virus (HCV) infection, so as to provide evidence for the implementation of hierarchical HCV screening in clinical practice. Methods: A total of 298 serum specimens from patients who underwent HCV antibody detection at Traditional Chinese Medicine Hospital of Meishan between October 2025 and May 2026 were enrolled in this study. Using HCV-RNA detection as the gold standard, the sensitivity, specificity, positive predictive value and negative predictive value were compared among the HCV Duo combined assay, isolated antibody assay and isolated antigen assay. Results: Among the 298 specimens, 62 were HCV RNA-positive and 236 were HCV RNA-negative; 48 specimens tested positive and 250 tested negative for HCV Duo-Ag, while 191 specimens tested positive and 107 tested negative for HCV Duo-Ab. Based on the results of HCV-RNA detection, the HCV Duo combined assay yielded 191 positive results, including 62 true-positive cases, 129 false-positive cases and 107 true-negative cases. The sensitivity and negative predictive value of the HCV Duo combined assay and isolated HCV Duo-Ab assay were significantly higher than those of the isolated HCV Duo-Ag assay (P < 0.05). The specificity, positive predictive value and diagnostic accuracy of the HCV Duo-Ag assay were markedly superior to those of the HCV Duo combined assay and isolated HCV Duo-Ab assay (P < 0.001). For HCV RNA-positive specimens, the positive detection rates of HCV Duo-Ag and HCV Duo-Ab were 77.42% and 100%, respectively (P < 0.001). For HCV RNA-negative specimens, the false-positive rates of HCV Duo-Ag and HCV Duo-Ab were 0% and 54.66%, respectively (P < 0.001). Conclusion: The high specificity of HCV Duo-Ag complements the high sensitivity of HCV Duo-Ab perfectly, which lays a theoretical foundation for the design of the HCV Duo combined detection strategy. A hierarchical screening protocol is recommended for clinical application, which can balance the risk of missed diagnosis and the cost of nucleic acid testing, and further standardize and optimize the routine screening workflow for hepatitis C.