Performance of Hepatitis Delta Virus(HDV)RNA Testing for the Diagnosis of Active HDV Infection:Systematic Review and Meta-analysis  

作　　者：Sisi Chen Xiangying Zhang Ling Xu Yuan Tian Zihao Fan Yaling Cao Zhenzhen Pan Yao Gao Sujun Zheng Zhongping Duan Mei Liu Feng Ren 

机构地区：[1]Beijing Institute of Hepatology,Beijing Youan Hospital,Capital Medical University,Beijing,China [2]The First Department of Liver Disease Center,Beijing Youan Hospital,Capital Medical University,Beijing,China [3]Fourth Department of Hepatology Center,Beijing Youan Hospital,Capital Medical University,Beijing,China [4]Department of Oncology,Beijing Youan Hospital,Capital Medical University,Beijing,China

出　　处：《Journal of Clinical and Translational Hepatology》2023年第6期1368-1376,共9页临床与转化肝病杂志（英文版）

基　　金：supported by National Natural Science Foundation of China(grant numbers 81770611,82002243,82100653);Key Projects of the Beijing Municipal Education Commission’s Science and Technology Plan(grant number KZ202010025035);Special Key Research Project of Capital Health Development Scientific Research(grant numbers SF2020-1-1151,SF2021-1G-2181,SF2022-1-2182);Demonstrating Application and Research of Clinical Diagnosis and Treatment Technology in Beijing(grant numbers Z191100006619096,Z191100006619097);Beijing Talents Foundation(grant number 2018000021469G289);Beijing Hospitals Authority Youth Program(grant number QML20201702);Talent Cultivation Plan of“Climbing the Peak”of Beijing Municipal Hospital Administration(grant number DFL20221503).

摘　　要：Background and Aims:Hepatitis delta virus(HDV)is a defective virus and causes severe liver disease.Several HDV RNA assays have been developed,however the diagnostic efficacy remains unclear.This systematic review and metaanalysis aims to evaluate the diagnostic accuracy of HDV RNA assays to aid in the diagnosis of active hepatitis D.Methods:The PubMed,Embase,and Cochrane Library databases were systematically searched from the beginning to June 31,2022.Information on the characteristics of the literature and data on sensitivity,specificity,and area under curve(AUC)of the receiver operating characteristic(ROC)were extracted.Stata 14.0 was used for meta-analysis of the combined sensitivity,specificity,positive likelihood ratio,and negative likelihood ratio.Results:A total of 10 studies were included in the meta-analysis.The summary sensitivity,specificity,positive likelihood ratio,negative likelihood ratio,and diagnostic odds ratio of HDV RNA assays for HDV diagnosis were 0.92(95%CI:0.87-0.95),0.90(95%CI:0.86-0.93),7.74(95%CI:5.31-11.29),0.10(95%CI:0.06-0.18)and 99.90(95%CI:47.08-211.99),respectively.The AUC of the pooled ROC curve was 0.95(95%CI:0.92-0.96).Conclusions:The results show that HDV RNA assays had high diagnostic performance.However,that is limited by the number and quality of studies.Standard protocols for the development of assays by manufacturers and larger studies on the use of the assays are needed.

关 键 词：Hepatitis viruses Hepatitis delta virus DIAGNOSIS Sensitivity SPECIFICITY 

分 类 号：R512.63[医药卫生—内科学]