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Real-Time Polymerase Chain Reaction-Based Detection and Quantification of Hepatitis B Virus DNA
Published on: December 15, 2023
Detection of hepatitis B virus markers using a biosensor based on imaging ellipsometry.
Journal of Viral Hepatitis
|June 3, 2009
Summary
A novel biosensor using imaging ellipsometry (BIE) effectively detects five hepatitis B virus (HBV) markers. This high-throughput method shows potential for rapid clinical diagnosis of HBV infection.
Area of Science:
- Biomedical Engineering
- Infectious Disease Diagnostics
- Biosensor Technology
Background:
- Hepatitis B virus (HBV) infection remains a significant global health concern.
- Accurate and rapid diagnostic tools are crucial for effective HBV management and treatment.
- Existing diagnostic methods can be time-consuming or lack the capacity for simultaneous multi-marker detection.
Purpose of the Study:
- To develop and validate a biosensor based on imaging ellipsometry (BIE) for the simultaneous detection of five key HBV infection markers.
- To establish and optimize the methodology for clinical diagnosis, including ligand screening, sensitivity determination, and cut-off value (CoV) setting.
- To compare the performance of the BIE biosensor with established clinical methods like Enzyme-Linked Immunosorbent Assay (ELISA).
Main Methods:
- Development of a biosensor utilizing imaging ellipsometry (BIE) technology.
- Establishment of a matrix assay method for ligand screening and selection of high-bioactivity ligands.
- Determination of sensitivity and cut-off values (CoVs) for five HBV markers using receiver operating characteristic (ROC) curves.
- Validation of the BIE biosensor against ELISA as the reference method in 169 patients.
Main Results:
- High bioactivity ligands were selected, achieving sensitivities of 1 ng/mL for hepatitis B surface antigen (HBsAg) and 1 IU/mL for surface antibody (anti-HBs).
- Established CoVs for HBsAg, anti-HBs, hepatitis B e antigen, hepatitis B e antibody, and core antibody were 15%, 18%, 15%, 20%, and 15%, respectively.
- The BIE biosensor demonstrated the capability to simultaneously detect up to five HBV markers within one hour.
- Results from the BIE biosensor showed acceptable agreement with the reference ELISA method.
Conclusions:
- The developed BIE biosensor is a sensitive and specific tool for detecting multiple HBV markers.
- The methodology is robust, enabling efficient ligand screening, sensitivity assessment, and CoV determination.
- The BIE biosensor offers a high-throughput, rapid, and reliable alternative for hepatitis B diagnosis, showing significant potential for clinical application.

