Khan Harun, Hill Andrew, Main Janice, Brown Ashley, Cooke Graham
Faculty of Medicine, Imperial College London, United Kingdom.
Department of Pharmacology and Therapeutics, Liverpool University, United Kingdom.
Open Forum Infect Dis. 2017 May 26;4(2):ofw252. doi: 10.1093/ofid/ofw252. eCollection 2017 Spring.
The complexity and cost of current diagnostics for hepatitis C virus (HCV) may act as a prevention to the scale-up of treatment in the developing world. Currently, ribonucleic acid (RNA)-polymerase chain reaction tests are the gold standard. However, there is potential for the use of simpler and cheaper antigen tests to confirm HCV infection in different clinical settings. We evaluated the sensitivity and specificity of antigen assays. This was compared with the reference-standard RNA assays. A subanalysis also assessed Architect core antigen test, which is the only commercially available antigen test on the market. In 24 datasets, evaluating HCV-antigen assays in 8136 samples, the percentage of HCV-antigen positive, HCV-RNA negative was 0.57%. The percentage HCV-antigen negative, HCV-RNA positive was 3.52%. There is strong evidence that antigen detection performs as well as RNA-based assays for HCV management. The use of antigen tests could improve access to HCV care in underresourced healthcare settings.
当前丙型肝炎病毒（HCV）诊断方法的复杂性和成本可能会阻碍在发展中国家扩大治疗规模。目前，核糖核酸（RNA）聚合酶链反应检测是金标准。然而，在不同临床环境中，使用更简单、更便宜的抗原检测来确认HCV感染具有可能性。我们评估了抗原检测的敏感性和特异性，并将其与参考标准RNA检测进行比较。一项亚分析还评估了Architect核心抗原检测，这是市场上唯一可获得的商业抗原检测。在24个数据集中，对8136份样本进行HCV抗原检测评估，HCV抗原阳性、HCV-RNA阴性的比例为0.57%。HCV抗原阴性、HCV-RNA阳性的比例为3.52%。有充分证据表明，抗原检测在HCV管理方面与基于RNA的检测效果相当。使用抗原检测可以改善资源匮乏的医疗环境中获得HCV治疗的机会。
