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Rapid fluorescent lateral-flow immunoassay for hepatitis B virus genotyping
Liu-Wei Song1,2, Ying-Bin Wang1,2, Lin-Lin Fang1,2
1†National Institute of Diagnostics and Vaccine Development in Infectious Diseases, State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, School of Life Sciences, Xiamen University, Xiamen 361102, China.
Analytical Chemistry
|April 21, 2015
Summary
A new DNA-independent assay offers a fast and reliable method for Hepatitis B virus (HBV) genotyping. This fluorescent lateral flow immunoassay (LFIA) simplifies clinical management for chronic hepatitis B patients.
Area of Science:
- Virology
- Immunology
- Biotechnology
Background:
- Hepatitis B virus (HBV) genotyping is crucial for managing chronic hepatitis B (CHB).
- Existing nucleic acid-based genotyping methods are costly, slow, and inconvenient.
- A need exists for a more accessible and efficient HBV genotyping tool.
Purpose of the Study:
- To develop and evaluate a novel DNA-independent HBV genotyping tool.
- To create a rapid, convenient, and reliable assay for differentiating HBV genotypes.
- To assess the performance of the new assay in clinical cohorts.
Main Methods:
- Development of genotype-specific monoclonal antibodies (mAbs) against HBV.
- Creation of a one-step fluorescent lateral flow immunoassay (LFIA) using mAbs.
- Evaluation of the GT-LFIA assay in clinical samples from CHB patients.
Main Results:
- A novel GT-LFIA was successfully developed, differentiating HBV genotypes A, B, C, and D.
- The assay demonstrated high accuracy, with 96.3% genotype differentiability and 99.5% concordance with sequencing in 456 CHB patients.
- The GT-LFIA provided reliable genotyping results even for patients with undetectable HBV DNA levels.
Conclusions:
- The developed GT-LFIA is a convenient, fast, and reliable tool for differential HBV genotyping.
- This assay is particularly valuable for CHB patients with low or undetectable HBV DNA levels.
- The GT-LFIA simplifies clinical management and improves accessibility for HBV genotyping.
