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

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

doi:10.14218/JCTH.2022.00107

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

J Clin Transl Hepatol. 2023 Nov 28;11(6):1368-1376. doi: 10.14218/JCTH.2022.00107. Epub 2023 Jun 14.

Authors

Sisi Chen¹, Xiangying Zhang¹, Ling Xu¹, Yuan Tian¹, Zihao Fan¹, Yaling Cao¹, Zhenzhen Pan¹, Yao Gao¹, Sujun Zheng², Zhongping Duan³, Mei Liu⁴, Feng Ren¹

Affiliations

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.

Abstract

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 meta-analysis 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.

Keywords: Diagnosis; Hepatitis delta virus; Hepatitis viruses; Sensitivity; Specificity.