ORIGINAL RESEARCH article
Front. Microbiol.
Sec. Infectious Agents and Disease
Volume 16 - 2025 | doi: 10.3389/fmicb.2025.1594410
This article is part of the Research TopicPathogenic microorganisms and biosafetyView all 3 articles
Analytical Performance and Standardization of Four HCV RNA Assays in China: An Evaluation of Sensitivity, Precision, and Genotype Inclusivity
Provisionally accepted
- 1Zhejiang Center for Disease Control and Prevention (Zhejiang CDC), Hangzhou, China
- 2National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China
- 3Minhang Hospital, Fudan University, Shanghai, Shanghai Municipality, China
- 4Yangpu Hospital, Tongji University, Yangpu, Shanghai, China
- 5Chinese Academy of Medical Sciences and Peking Union Medical College, Dongcheng, Beijing Municipality, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Accurate, specific, and sensitive detection and quantification of hepatitis C virus (HCV) RNA are critical for diagnosing and managing HCV infections. This study evaluated and compared the performance of four commercially available HCV RNA quantification reagents using standardized serum panels, providing evidence-based insights for clinical applications. Performance metrics, including analytical sensitivity, specificity, limit of detection (LOD), precision, genotype inclusivity (GT 1-6), and linearity, were assessed using seven distinct serum panels: basic, analytical specificity, seroconversion, analytical sensitivity, precision, genotype qualification, and linearity panels. All reagents demonstrated 100% analytical sensitivity and specificity (95% CI: 79.95-100), with no cross-reactivity to common interfering substances or viruses. LOD values for reagents A, B, C, and D were 25 IU/mL, 50 IU/mL, 50 IU/mL, and 50 IU/mL, respectively. Intra-and inter-assay coefficients of variation (CVs) for HCV genotypes 1-6 ranged from 1.48% to 4.37% and 1.74% to 4.84%, respectively. Strong linear correlations (R 2 >0.95) were observed between measured and expected HCV RNA levels across all reagents. These reagents exhibit high sensitivity, specificity, precision, and accuracy for HCV genotypes 1-6, with a wide linear range, making them suitable for clinical diagnosis and monitoring of HCV infections.
Keywords: Hepatitis C virus, RNA, Performance assessment, quantitative, Serum panel
Received: 16 Mar 2025; Accepted: 13 May 2025.
Copyright: © 2025 Yan, Xu, Zhang, Zhang, Fang, Pan, Zhang and Xing. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Junhang Pan, Zhejiang Center for Disease Control and Prevention (Zhejiang CDC), Hangzhou, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.