用于丙型肝炎筛查的干血斑丙型肝炎病毒核心抗原检测的诊断性能:系统回顾和荟萃分析

IF 6.8 3区 医学 Q1 VIROLOGY
Ana Treviño-Nakoura, Daniel Sepúlveda-Crespo, José M. Bellon, Helena Codina, Rafael Amigot-Sánchez, Marta Quero-Delgado, Pablo Ryan, Isidoro Martínez, Salvador Resino
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引用次数: 0

摘要

丙型肝炎病毒(HCV)筛查越来越多地使用干血斑(DBS)采样。HCVcAg 检测为诊断 HCV 感染提供了一种更快、更简便的方法。我们进行了一项系统回顾和荟萃分析,以评估雅培 ARCHITECT HCV Ag 检测试剂盒在使用 DBS 样品筛查活动性 HCV 感染时的诊断性能。我们从截至 2024 年 10 月 4 日在不同数据库(PROSPERO:CRD42022363975)中登记了检索策略的所有已发表研究中选出了 8 项研究(n = 1229)。金标准方法是 HCV PCR 检测。数据采用 STATA 中的 MIDAS 模块和随机效应模型进行分析。综合诊断准确性指标如下:敏感性 85%,特异性 100%,阳性似然比 (PLR) 233.1,阴性似然比 (NLR) 0.15,接受者操作特征总结 (SROC) 0.99。似然比和 Fagan 的提名图表明,在高流行率环境中(≥5%),使用 DBS 样品进行 HCVcAg 检测可确认或排除活动性 HCV 感染,准确率超过 92%。然而,在低流行率地区(≤1%),必须进行确证检验才能获得阳性结果。无论HCV感染率如何,该检验识别未感染HCV人群的能力都很高,误差率低于3%。这项荟萃分析存在一定的局限性,特别是由于纳入的研究数量较多,而且研究之间存在明显的异质性。使用雅培ARCHITECT HCV Ag检测法对DBS样本进行HCV筛查显示出卓越的诊断性能,但当HCV感染率较低时(≤1%),其外部有效性可能会受到限制。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Diagnostic performance of dried blood spot hepatitis C virus core antigen testing for hepatitis C screening: A systematic review and meta-analysis

Dried blood spot (DBS) sampling is increasingly used for hepatitis C virus (HCV) screening. HCVcAg testing offers a faster and more streamlined approach to diagnosing HCV infection. We conducted a systematic review and meta-analysis to assess the diagnostic performance of the Abbott ARCHITECT HCV Ag assay for screening active HCV infection using DBS samples. Eight studies (n = 1229) were selected among all published studies available up to October 4, 2024, in different databases with a search strategy registered (PROSPERO: CRD42022363975). The gold standard method was the HCV PCR test. Data were analyzed using the MIDAS module in STATA with a random effects model. Combined diagnostic accuracy measures were as follows: sensitivity 85%, specificity 100%, positive likelihood ratio (PLR) 233.1, negative likelihood ratio (NLR) 0.15, and summary receiver operating characteristic (SROC) 0.99. Likelihood ratios and Fagan's nomogram suggested that the HCVcAg assay with DBS samples can confirm or rule out active HCV infection with over 92% accuracy in high-prevalence settings (≥5%). However, in low-prevalence settings (≤1%), a confirmatory test must be required for positive results. The ability of the test to identify people without HCV infection was high regardless of HCV prevalence, with an error rate of less than 3%. This meta-analysis is subject to limitations, particularly due to the number of included studies and significant heterogeneity among them. HCV screening using the Abbott ARCHITECT HCV Ag assay with DBS samples showed excellent diagnostic performance, but its external validity may be limited when HCV prevalence is low (≤1%).

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来源期刊
Journal of Medical Virology
Journal of Medical Virology 医学-病毒学
CiteScore
23.20
自引率
2.40%
发文量
777
审稿时长
1 months
期刊介绍: The Journal of Medical Virology focuses on publishing original scientific papers on both basic and applied research related to viruses that affect humans. The journal publishes reports covering a wide range of topics, including the characterization, diagnosis, epidemiology, immunology, and pathogenesis of human virus infections. It also includes studies on virus morphology, genetics, replication, and interactions with host cells. The intended readership of the journal includes virologists, microbiologists, immunologists, infectious disease specialists, diagnostic laboratory technologists, epidemiologists, hematologists, and cell biologists. The Journal of Medical Virology is indexed and abstracted in various databases, including Abstracts in Anthropology (Sage), CABI, AgBiotech News & Information, National Agricultural Library, Biological Abstracts, Embase, Global Health, Web of Science, Veterinary Bulletin, and others.
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