High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing

Abstract Serum Hepatitis B virus (HBV) RNA serves as a non-invasive biomarker for monitoring chronic hepatitis B and guiding treatment decisions. However, current diagnostic tests relying on Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) require centralized facilities and ted...

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Main Authors: Shixin Yan, Chuipeng Kong, Jiazhe Cheng, Zhuoyun Tang, Ke Sun, Shanchuan Chen, Minghan Li, Chengyan Tao, Yue Li, Yanhua Zhao, Chuanmin Tao, Jia Geng, Feng Li
Format: Article
Language:English
Published: Springer 2025-08-01
Series:Molecular Biomedicine
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Online Access:https://doi.org/10.1186/s43556-025-00282-7
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author Shixin Yan
Chuipeng Kong
Jiazhe Cheng
Zhuoyun Tang
Ke Sun
Shanchuan Chen
Minghan Li
Chengyan Tao
Yue Li
Yanhua Zhao
Chuanmin Tao
Jia Geng
Feng Li
author_facet Shixin Yan
Chuipeng Kong
Jiazhe Cheng
Zhuoyun Tang
Ke Sun
Shanchuan Chen
Minghan Li
Chengyan Tao
Yue Li
Yanhua Zhao
Chuanmin Tao
Jia Geng
Feng Li
author_sort Shixin Yan
collection DOAJ
description Abstract Serum Hepatitis B virus (HBV) RNA serves as a non-invasive biomarker for monitoring chronic hepatitis B and guiding treatment decisions. However, current diagnostic tests relying on Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) require centralized facilities and tedious operational steps, and there is currently no standardized HBV RNA detection method. Herein, we describe the rapid amplification-free detection of HBV RNA in clinical serum samples via a nanopore sensing method. Our method involves the design of a DNA nanomachine capable of translation of each target HBV RNA into a large amount of 7-nt single-strand DNA (ssDNA) as signal reporters that produce blockage features when passing through an alpha-hemolysin (α-HL) nanopore, the target can be quantified by identifying the frequency of this blockage occurrence. We demonstrate that this unique nanopore sensing feature not only distinguishes Signal Report (SR) DNA from interfering nucleic acids in clinical serum samples but also ensures a high assay sensitivity with a limit-of-detection (LOD) at 12.5 fM. The clinical potential of this method was validated through testing serum samples from 26 HBV-infected-patients and 7 healthy-participants. When compared with the RT-qPCR method, it showed only one false result, achieving an accuracy rate of 97.0%. Additionally, testing results for 18 cases during the treatment period demonstrated that our method’s conclusions on continued treatment and drug discontinuation were highly consistent with clinical diagnoses, with an accuracy rate of 100%. Therefore, the method developed in this study expands the clinical applications of 3D DNA nanomachine and nanopore sensing technology in clinical detection.
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spelling doaj-art-31ef5f32aefb44ebb5c2e9fd3e2989d82025-08-20T04:01:42ZengSpringerMolecular Biomedicine2662-86512025-08-016111610.1186/s43556-025-00282-7High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensingShixin Yan0Chuipeng Kong1Jiazhe Cheng2Zhuoyun Tang3Ke Sun4Shanchuan Chen5Minghan Li6Chengyan Tao7Yue Li8Yanhua Zhao9Chuanmin Tao10Jia Geng11Feng Li12Department of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterKey Laboratory of Green Chemistry & Technology of Ministry of Education, College of Chemistry, Sichuan UniversityDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterDepartment of Laboratory Medicine, West China Hospital, Sichuan UniversityDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterDepartment of Laboratory Medicine, West China Hospital, Sichuan UniversityDepartment of Laboratory Medicine, West China Hospital, Sichuan UniversityDepartment of Laboratory Medicine, State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University and Collaborative Innovation CenterKey Laboratory of Green Chemistry & Technology of Ministry of Education, College of Chemistry, Sichuan UniversityAbstract Serum Hepatitis B virus (HBV) RNA serves as a non-invasive biomarker for monitoring chronic hepatitis B and guiding treatment decisions. However, current diagnostic tests relying on Reverse Transcription Quantitative Polymerase Chain Reaction (RT-qPCR) require centralized facilities and tedious operational steps, and there is currently no standardized HBV RNA detection method. Herein, we describe the rapid amplification-free detection of HBV RNA in clinical serum samples via a nanopore sensing method. Our method involves the design of a DNA nanomachine capable of translation of each target HBV RNA into a large amount of 7-nt single-strand DNA (ssDNA) as signal reporters that produce blockage features when passing through an alpha-hemolysin (α-HL) nanopore, the target can be quantified by identifying the frequency of this blockage occurrence. We demonstrate that this unique nanopore sensing feature not only distinguishes Signal Report (SR) DNA from interfering nucleic acids in clinical serum samples but also ensures a high assay sensitivity with a limit-of-detection (LOD) at 12.5 fM. The clinical potential of this method was validated through testing serum samples from 26 HBV-infected-patients and 7 healthy-participants. When compared with the RT-qPCR method, it showed only one false result, achieving an accuracy rate of 97.0%. Additionally, testing results for 18 cases during the treatment period demonstrated that our method’s conclusions on continued treatment and drug discontinuation were highly consistent with clinical diagnoses, with an accuracy rate of 100%. Therefore, the method developed in this study expands the clinical applications of 3D DNA nanomachine and nanopore sensing technology in clinical detection.https://doi.org/10.1186/s43556-025-00282-73D-DNA nanomachineNanopore sensingHepatitis B virus RNAssDNAClinical detection
spellingShingle Shixin Yan
Chuipeng Kong
Jiazhe Cheng
Zhuoyun Tang
Ke Sun
Shanchuan Chen
Minghan Li
Chengyan Tao
Yue Li
Yanhua Zhao
Chuanmin Tao
Jia Geng
Feng Li
High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing
Molecular Biomedicine
3D-DNA nanomachine
Nanopore sensing
Hepatitis B virus RNA
ssDNA
Clinical detection
title High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing
title_full High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing
title_fullStr High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing
title_full_unstemmed High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing
title_short High sensitivity detection of Hepatitis B virus RNA based on 3D-DNA nanomachine and protein nanopore sensing
title_sort high sensitivity detection of hepatitis b virus rna based on 3d dna nanomachine and protein nanopore sensing
topic 3D-DNA nanomachine
Nanopore sensing
Hepatitis B virus RNA
ssDNA
Clinical detection
url https://doi.org/10.1186/s43556-025-00282-7
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