Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis.
Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis.
复制标题
DOI：
10.7326/m16-0065
复制
发表时间：
2016-09-06
影响因子：
39.2
通讯作者：
Denkinger CM
中科院分区：
文献类型：
--
作者：
Freiman JM;Tran TM;Schumacher SG;White LF;Ongarello S;Cohn J;Easterbrook PJ;Linas BP;Denkinger CM
慢性丙型肝炎病毒感染的诊断需要同时进行阳性的丙型肝炎病毒抗体筛查和确认性核酸试验。丙型肝炎病毒核心抗原(HCVcAg)是NAT的潜在替代品。这项系统性综述评估了与NAT相比，五种HCVcAg检测在成人和儿童中诊断活动性丙型肝炎病毒感染的准确性。EMBASE、PubMed、Web of Science、Scope us和Cochrane，从1990年到2016年3月31日。纳入了无语言限制的队列、横断面和随机对照试验。两名独立的评价者提取数据，并使用改编的诊断准确性研究质量评估(QUADAS-2)工具进行评估。44项研究评估了5项指数测试。建筑师的研究质量最高，而Ortho ELISA的研究质量最低。双因素分析的灵敏度和特异度分别为：Architect 93.4%(90.1，96.4)和98.8%(97.4，99.5)，Ortho EL ISA 93.2%(81.6，97.7)和99.2%(87.9,100)，湖南金达59.5%(46.0，71.7)和82.9%(58.6，94.3)。没有足够的数据用于Lumipulse和Lumispot的荟萃分析。在使用Architect进行的三项定量研究中，HCVcAg与丙型肝炎病毒RNA的相关性高于3000IU/mL。对于分组分析，没有关于艾滋病毒或乙肝病毒状况等协变量的足够数据。很少有研究报道分离株的基因类型，也没有关于基因4、5和6的数据。大多数研究是在参考实验室内的高资源环境下进行的。信号放大法检测HCVcAg具有高灵敏度、高特异性，与3000IU/mL以上的HCVcAg有较好的相关性。在丙型肝炎高流行环境中，HCVcAg检测有可能取代NAT。
Diagnosis of chronic Hepatitis C Virus (HCV) infection requires both a positive HCV antibody screen and confirmatory nucleic acid test (NAT). HCV core antigen (HCVcAg) is a potential alternative to NAT. This systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for five HCVcAg tests compared to NAT. EMBASE, PubMed, Web of Science, Scopus, and Cochrane from 1990 through March 31, 2016. Cohort, cross-sectional, and randomized controlled trials were included without language restriction Two independent reviewers extracted data and assessed quality using an adapted Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. 44 studies evaluated 5 index tests. Studies for the ARCHITECT had the highest quality, while those for Ortho ELISA were the lowest. From bivariate analyses, the sensitivity and specificity with 95% CI were: ARCHITECT 93.4% (90.1, 96.4) and 98.8% (97.4, 99.5), Ortho ELISA 93.2% (81.6, 97.7) and 99.2% (87.9, 100), and Hunan Jynda 59.5% (46.0, 71.7) and 82.9% (58.6, 94.3). Insufficient data were available for a meta-analysis for Lumipulse and Lumispot. In three quantitative studies using ARCHITECT, HCVcAg correlated closely with HCV RNA above 3000 IU/mL. There was insufficient data on covariates such as HIV or HBV status for sub-group analyses. Few studies reported genotypes of isolates and there were scant data for genotypes 4, 5, and 6. Most studies were conducted in high resource settings within reference laboratories. HCVcAg assays with signal amplification have high sensitivity, high specificity, and good correlation with HCV RNA above 3000 IU/mL. HCVcAg assays have the potential to replace NAT in high HCV prevalence settings.